1. TEL AVIV, Israel and RALEIGH, NC, Sept. 14, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in hospitalized patients with severe COVID-19 pneumonia.

    RedHill Biopharma Ltd. Logo

    Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.

    Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings…

    TEL AVIV, Israel and RALEIGH, NC, Sept. 14, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in hospitalized patients with severe COVID-19 pneumonia.

    RedHill Biopharma Ltd. Logo

    Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.

    Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced results from the U.S. Phase 2 study and the previously observed antiviral activity of opaganib.

    "We would like to thank the patients, physicians and supporting medical staff who took part in this important study. While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease. This correlates with what we know about opaganib's strong antiviral mechanism and effect against variants, as well as its mechanism of action and previously announced results from the Phase 2 U.S. study with opaganib," said Dror Ben Asher, RedHill CEO. "In parallel, we continue to make progress with our Phase 2/3 study with another novel, orally-administered drug candidate, RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, with the recent approval of the study in South Africa and its expansion within the United States. We are determined to continue our efforts to advance potential treatments to address COVID-19 and its overwhelming impact worldwide."

    The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14.

    Analysis of the top-line data is ongoing, including an analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the data with regulators, including U.S. FDA and foreign regulators, to help determine next steps.

    The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature, as they are based solely on top-line information provided to the Company by an independent third-party contractor. The Company intends to examine the data from this study in greater detail, along with all of the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the top-line results reported in this release as the final definitive results of the study.

    Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication.

    About Opaganib (ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently published in medRxiv.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of all SARS-CoV-2 variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib's potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].

    The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that in the next studies opaganib will not be found effective in decreasing renal fibrosis; that further analysis of the top-line results of the Phase 2/3 COVID-19 study for opaganib results in findings inconsistent with the top-line data disclosed in this release; that no further COVID-19 studies for opaganib will be commenced, and if commenced, may not be successful, including with respect to patients in earlier stages of COVID-19 on low flow oxygen support; that the Phase 2/3 study for RHB-107 in COVID-9 patients may not be successful;  that any additional studies for opaganib and the Phase 2/3 study for RHB-107 in COVID-19 patients, even if successful, will not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 will be required by regulatory authorities to support such potential applications and the use or marketing of opaganib or RHB-107 for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.      

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

     

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  2. RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval

    The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    -

    Number of U.S. sites for the study has also been expanded

    -

    RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants

    -

    RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19

    -

    In parallel RedHill's leading oral COVID-19 therapeutic,

    RedHill Biopharma Accelerates Ongoing U.S. Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients with South African Approval

    The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    -

    Number of U.S. sites for the study has also been expanded

    -

    RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants

    -

    RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19

    -

    In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming

    TEL AVIV, ISREAL and RALEIGH, NC / ACCESSWIRE / September 13, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that South Africa has joined the U.S. in approving the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat) [1] for non-hospitalized patients with symptomatic COVID-19. The study is already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.

    RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.

    "South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of study sites in the U.S., are aimed at accelerating our efforts to bring RedHill's two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world."

    The Phase 2/3 study ( NCT04723527 ) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment that can be prescribed and used in the largest, non-hospitalized, patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.

    In parallel, top-line results are upcoming from the opaganib [2] global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill's other advanced COVID-19 oral drug candidate.

    About RHB-107 (upamostat)
    RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in several indications in oncology, inflammatory and gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

    About RedHill Biopharma
    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik ® for opioid-induced constipation in adults, Talicia ® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo ® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204 , with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( ABC294640) , a first - in - class, oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 ( upamostat ), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104 , with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB - 106 , an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio .

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the Company's Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia ® ; (v) the Company's ability to successfully commercialize and promote Movantik ® , Talicia ® and Aemcolo ® ; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:
    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com
    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783 fennell@consilium-comms.com

    [1] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.
    [2] Opaganib (ABC294640) is an investigational new drug, not available for commercial distribution in the United States.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com .

    SOURCE: RedHill Biopharma Ltd



    View source version on accesswire.com:
    https://www.accesswire.com/663701/RHB-107-P23-COVID-19-Study-South-Africa-Approval

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  3. The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    Number of U.S. sites for the study has also been expanded

    RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants

    RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19

    In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming

    TEL AVIV,

    The South African Health Products Regulatory Authority (SAHPRA) has approved the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care

    Number of U.S. sites for the study has also been expanded

    RHB-107, a novel antiviral serine protease inhibitor targeting human cell factors, is expected to be effective against emerging viral variants

    RHB-107 is being developed as a potential treatment with a simple once-daily oral pill in the early course of COVID-19

    In parallel RedHill's leading oral COVID-19 therapeutic, opaganib, is being evaluated in a global Phase 2/3 study in 475 patients hospitalized with severe COVID-19, with top-line results upcoming

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 13, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that South Africa has joined the U.S. in approving the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is already ongoing in the U.S., with expansion of study sites underway to further accelerate recruitment.

    RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.

    "South Africa continues to face an onslaught of COVID-19 that is claiming many lives and causing significant distress to the healthcare system. South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat COVID-19 and its variants, both inside and outside the hospital setting," said Terry F. Plasse MD, Medical Director at RedHill. "As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms. The approval of this study in South Africa, along with the expansion of study sites in the U.S., are aimed at accelerating our efforts to bring RedHill's two novel, oral compounds that cover the spectrum of COVID-19 disease severity, RHB-107 and opaganib, to patients across the world."

    The Phase 2/3 study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment that can be prescribed and used in the largest, non-hospitalized, patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed for dose selection and to evaluate time to sustained recovery from illness as the primary endpoint. Patients are also tested for specific viral strain.

    In parallel, top-line results are upcoming from the opaganib[2] global 475-patient Phase 2/3 study in patients hospitalized with severe COVID-19 - RedHill's other advanced COVID-19 oral drug candidate.

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in several indications in oncology, inflammatory and gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( ABC294640), a first-in-class, oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the Company's Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 and/or opaganib will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating RHB-107 and/or opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the Company will not initiate the Phase 2/3 study for RHB-107 in certain geographies, including South Africa, will not expand this study to additional sites in the U.S. and that it will not be successful and that enrollment will be delayed; the risk that COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a relatively new disease, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using RHB-107, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    1. RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.

    2. Opaganib (ABC294640) is an investigational new drug, not available for commercial distribution in the United States.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1-212-529-2236

    bryan.gibbs@finnpartners.com  

    UK: Amber Fennell, Consilium

    +44 (0)7739 658783 

    fennell@consilium-comms.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/redhill-biopharma-accelerates-ongoing-us-phase-23-covid-19-study-of-once-daily-oral-rhb-107-in-non-hospitalized-patients-with-south-african-approval-301375125.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  4. COVID-19 and long COVID patients are at increased risk of developing kidney damage
    -
    Opaganib significantly decreased kidney fibrosis in a preclinical in vivo model
    -
    Renal fibrosis is a progressive process which occurs in patients with chronic kidney disease (CKD) and can ultimately lead to end-stage renal failure
    -
    Opaganib is a novel, late clinical-stage oral pill drug candidate with dual anti-inflammatory and antiviral activity and has already demonstrated strong inhibition against variants of concern, including Delta
    -
    The global 475-patient Phase 2/3 study with opaganib oral pill in hospitalized COVID-19 patients has completed treatment and follow up phase, with top-line results upcoming

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September

    COVID-19 and long COVID patients are at increased risk of developing kidney damage
    -
    Opaganib significantly decreased kidney fibrosis in a preclinical in vivo model
    -
    Renal fibrosis is a progressive process which occurs in patients with chronic kidney disease (CKD) and can ultimately lead to end-stage renal failure
    -
    Opaganib is a novel, late clinical-stage oral pill drug candidate with dual anti-inflammatory and antiviral activity and has already demonstrated strong inhibition against variants of concern, including Delta
    -
    The global 475-patient Phase 2/3 study with opaganib oral pill in hospitalized COVID-19 patients has completed treatment and follow up phase, with top-line results upcoming

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 7, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results of a new preclinical study demonstrating opaganib's (ABC294640)[1] efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model. Reports suggest that over 20% of hospitalized COVID-19 patients experience acute renal failure[2].

    Kidney fibrosis generally leads to loss of tissue function and subsequent organ failure, with high mortality rate. New therapeutic small molecules to modulate fibrosis are urgently needed. The aim of the in vivo efficacy study was to verify the effect of opaganib on kidney inflammation and fibrosis in a unilateral ureteral obstruction (UUO) model - a well characterized model for renal fibrosis. Results from the study showed that opaganib significantly decreased renal fibrosis.

    "A final, common pathway in chronic kidney disease is fibrosis, the formation of internal scar tissue, which can cause devastating effects and can ultimately lead to end-stage kidney failure. This new preclinical data, demonstrating opaganib's ability to decrease kidney fibrosis, along with its observed anti-inflammatory properties, positions opaganib as a potential novel therapy for the millions of patients suffering from chronic kidney disease and potentially extends to COVID-19 patients with Acute Kidney Injury (AKI) who are at risk of developing renal fibrosis," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Kidney injury and its associated progression to fibrosis is an important facet in both the acute phase of COVID-19 and in long COVID. Recent research has shown that after acute kidney injury, which we know can be a result of COVID-19 infection, the kidneys often fail to repair themselves properly and that sphingosine kinase-2 (SK2), which is inhibited by opaganib, is part of this process. These findings provide further support for the extensive work we are doing with opaganib in COVID-19. With the upcoming readout, we expect to learn more about kidney outcomes from hospitalized COVID-19 patients treated with opaganib in our global Phase 2/3 study."

    Renal fibrosis, a common outcome of chronic kidney disease (CKD), is characterized by an excessive accumulation and deposition of extracellular matrix (ECM) components and fibrous tissue. Renal fibrosis may ultimately lead to end-stage renal failure, a devastating disorder that requires dialysis or kidney transplantation. CKD is a very common disease, affecting 15% of U.S. adults[3].

    Recent studies have found that patients infected with SARS-CoV-2 are at increased risk of developing kidney damage, as well as chronic and end-stage kidney disease., associated with morbidity and mortality in these patients. Findings have suggested that beyond the acute phase of the disease, COVID-19 survivors, even those who did not require hospitalization, exhibit an increased risk of developing major adverse kidney disease such as CKD. In addition, data suggests that approximately 10% of people infected with COVID-19 may experience long COVID (post-acute sequalae), potentially involving acute kidney-related outcomes[4].

    Opaganib, a leading novel small molecule investigational oral pill in development for the treatment of COVID-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication. Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow up phase, and study top-line results are upcoming.

    Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[5]. Furthermore, the opaganib Phase 2/3 study has also passed four Data Safety Monitoring Board reviews, as well as a futility review, extending the total opaganib safety database to more than 460 patients and healthy subjects. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, has been recently published in medRxiv. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.

    About Opaganib (ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study that has completed patient treatment and follow-up, with top-line results upcoming. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently published in medRxiv.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[6].

    The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that in the next studies opaganib will not be found effective in decreasing renal fibrosis, the delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:
    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com
    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783
    fennell@consilium-comms.com

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Nadim, M.K., Forni, L.G., Mehta, R.L. et al. COVID-19-associated acute kidney injury: consensus report of the 25th Acute Disease Quality Initiative (ADQI) Workgroup. Nat Rev Nephrol 16, 747-764 (2020).

    [3] Centers for Disease Control and Prevention - Chronic Kidney Disease in the United States, 2021

    [4] Bowe B, Xie Y, Xu E, Al-Aly Z, Kidney Outcomes in Long COVID. JASN Sep 2021

    [5] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-head comparison study.

    [6] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd



    View source version on accesswire.com:
    https://www.accesswire.com/662954/RedHill-Biopharmas-Opaganib-Demonstrates-Significant-Decrease-of-Kidney-Fibrosis

    View Full Article Hide Full Article
  5. TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results of a new preclinical study demonstrating opaganib's (ABC294640)[1] efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model. Reports suggest that over 20% of hospitalized COVID-19 patients experience acute renal failure[2].

    RedHill Biopharma Logo

    Kidney fibrosis generally leads to loss of tissue function and subsequent organ failure, with high mortality rate. New therapeutic small molecules to modulate fibrosis are urgently needed. The aim of the in vivo efficacy study was to verify the effect of opaganib…

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results of a new preclinical study demonstrating opaganib's (ABC294640)[1] efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model. Reports suggest that over 20% of hospitalized COVID-19 patients experience acute renal failure[2].

    RedHill Biopharma Logo

    Kidney fibrosis generally leads to loss of tissue function and subsequent organ failure, with high mortality rate. New therapeutic small molecules to modulate fibrosis are urgently needed. The aim of the in vivo efficacy study was to verify the effect of opaganib on kidney inflammation and fibrosis in a unilateral ureteral obstruction (UUO) model – a well characterized model for renal fibrosis. Results from the study showed that opaganib significantly decreased renal fibrosis.

    "A final, common pathway in chronic kidney disease is fibrosis, the formation of internal scar tissue, which can cause devastating effects and can ultimately lead to end-stage kidney failure. This new preclinical data, demonstrating opaganib's ability to decrease kidney fibrosis, along with its observed anti-inflammatory properties, positions opaganib as a potential novel therapy for the millions of patients suffering from chronic kidney disease and potentially extends to COVID-19 patients with Acute Kidney Injury (AKI) who are at risk of developing renal fibrosis," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Kidney injury and its associated progression to fibrosis is an important facet in both the acute phase of COVID-19 and in long COVID. Recent research has shown that after acute kidney injury, which we know can be a result of COVID-19 infection, the kidneys often fail to repair themselves properly and that sphingosine kinase-2 (SK2), which is inhibited by opaganib, is part of this process. These findings provide further support for the extensive work we are doing with opaganib in COVID-19. With the upcoming readout, we expect to learn more about kidney outcomes from hospitalized COVID-19 patients treated with opaganib in our global Phase 2/3 study."

    Renal fibrosis, a common outcome of chronic kidney disease (CKD), is characterized by an excessive accumulation and deposition of extracellular matrix (ECM) components and fibrous tissue. Renal fibrosis may ultimately lead to end-stage renal failure, a devastating disorder that requires dialysis or kidney transplantation. CKD is a very common disease, affecting 15% of U.S. adults[3].

    Recent studies have found that patients infected with SARS-CoV-2 are at increased risk of developing kidney damage, as well as chronic and end-stage kidney disease., associated with morbidity and mortality in these patients. Findings have suggested that beyond the acute phase of the disease, COVID-19 survivors, even those who did not require hospitalization, exhibit an increased risk of developing major adverse kidney disease such as CKD. In addition, data suggests that approximately 10% of people infected with COVID-19 may experience long COVID (post-acute sequalae), potentially involving acute kidney-related outcomes[4].

    Opaganib, a leading novel small molecule investigational oral pill in development for the treatment of COVID-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication. Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow up phase, and study top-line results are upcoming.

    Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[5]. Furthermore, the opaganib Phase 2/3 study has also passed four Data Safety Monitoring Board reviews, as well as a futility review, extending the total opaganib safety database to more than 460 patients and healthy subjects. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, has been recently published in medRxiv. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.

    About Opaganib (ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study that has completed patient treatment and follow-up, with top-line results upcoming. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, recently published in medRxiv.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[6].

    The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma      

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that in the next studies opaganib will not be found effective in decreasing renal fibrosis, the delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Nadim, M.K., Forni, L.G., Mehta, R.L. et al. COVID-19-associated acute kidney injury: consensus report of the 25th Acute Disease Quality Initiative (ADQI) Workgroup. Nat Rev Nephrol 16, 747–764 (2020).

    [3] Centers for Disease Control and Prevention – Chronic Kidney Disease in the United States, 2021

    [4] Bowe B, Xie Y, Xu E, Al-Aly Z, Kidney Outcomes in Long COVID. JASN Sep 2021

    [5] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-head comparison study.

    [6] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharmas-opaganib-demonstrates-significant-decrease-of-kidney-fibrosis-301370133.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  6. RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021

    Two new analyses of Movantik® (naloxegol) data evaluated the safety and efficacy of Movantik in a subgroup of patients aged ≥ 65 years

    --

    Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid dosages

    --

    Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 7, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company…

    RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021

    Two new analyses of Movantik® (naloxegol) data evaluated the safety and efficacy of Movantik in a subgroup of patients aged ≥ 65 years

    --

    Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid dosages

    --

    Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 7, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and high dose opioid therapy.

    Two of the posters are dedicated to the subgroup of patients aged ≥ 65, with Movantik achieving significantly better response rates vs. placebo, with rapid onset of action and a higher proportion of subjects achieving spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) over the first 48 hours of treatment. Additional presented data also shows that naloxegol delivers similar rapid and sustained symptom improvement for patients, irrespective of the opioid dose they are prescribed, including at doses lower than 100 mg of morphine equivalent. The authors conclude that even with lower doses of morphine equivalent, clinicians should be diligent about treating these patients because they still are susceptible to OIC.

    The three analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the placebo arms.

    "With up to 90% of older patients receiving opioids to help cope with chronic pain, and up to 86% of them suffering from symptoms of OIC, these new analyses are particularly important in helping these patients achieve satisfactory control of their pain without the added burden of OIC. Older patients tend to be more susceptible to OIC due to comorbidities, polypharmacy, and reduced physical activity, and it is vital that they have access to therapies such as Movantik, that are shown to be effective in this challenging patient group." said Dr. Lynn Webster, Pain Researcher and Clinician and Senior Fellow at the Center of U.S. Policy.

    "There has been a shift in clinical practice to try to reduce doses of opioids used to treat chronic pain. However, low dose opioid therapy can prove to be equally troublesome in terms of treatment-related constipation as higher doses and it is important that physicians are diligent in monitoring for signs of OIC," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "This new analysis showing Movantik's efficacy irrespective of opioid dose is equally important in supporting the clinical shift to low dose opioid therapy through the management of OIC which can be expected in between 40-80% of patients taking chronic opioid therapy[1]."

    New Movantik (Naloxegol) Analyses Presented at PAINWeek 2021:

    Poster 1 (poster number 55):

    Naloxegol Provided Rapid Onset of Time to First Spontaneous Bowel Movement (SBM), Complete SBM and Predictable Efficacy in Older Adults (Age ≥ 65 Yrs): A Pooled Analysis of Two Phase 3 Studies

    Authors: Lynn Webster, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Martin Hale

    Poster 2 (poster number 59):

    Naloxegol Provided Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)

    Symptoms in Older Adults Age ≥ 65 Yrs: A Pooled Analysis of Two Phase 3 Studies

    Authors: Martin Hale, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Lynn Webster

    Poster 3 (poster number 30):

    Naloxegol Provides Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)

    Symptoms Irrespective of Opioid Dose: A Pooled Analysis of Two Phase 3 Studies

    Authors: Jeffrey Gudin, Jeremy A. Adler, June Almenoff, Carol B. Rockett, Enoch Bortey, Richard Rauck, Lynn Webster

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[2], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[3], and Aemcolo® for the treatment of travelers' diarrhea in adults[4]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About Movantik® (naloxegol)

    Movantik® is an opioid antagonist indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Important Safety Information About Movantik

    Movantik® (naloxegol) is contraindicated in:

    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.

    Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.

    • Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.

    Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.

    Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

    Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Click here for the Medication Guide and full Prescribing Information for Movantik.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    MOVANTIK is a registered trademark of the AstraZeneca group of companies.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate and Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783

    fennell@consilium-comms.com


    [1] Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

    [2] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    [3] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    [4] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word "Reach" in the source column of the News Explorer pages of London Stock Exchange's website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

    SOURCE: RedHill Biopharma Ltd



    View source version on accesswire.com:
    https://www.accesswire.com/662950/RedHill-Biopharma-Ltd-Announces-New-Movantik-Analyses-at-PAINWeek

    View Full Article Hide Full Article
  7. TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and high dose opioid therapy.

    RedHill Biopharma Logo

    Two of the posters are dedicated to the subgroup of patients aged ≥ 65, with Movantik achieving significantly better response rates vs. placebo, with rapid onset of action and a higher proportion of subjects achieving spontaneous bowel…

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and high dose opioid therapy.

    RedHill Biopharma Logo

    Two of the posters are dedicated to the subgroup of patients aged ≥ 65, with Movantik achieving significantly better response rates vs. placebo, with rapid onset of action and a higher proportion of subjects achieving spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) over the first 48 hours of treatment. Additional presented data also shows that naloxegol delivers similar rapid and sustained symptom improvement for patients, irrespective of the opioid dose they are prescribed, including at doses lower than 100 mg of morphine equivalent. The authors conclude that even with lower doses of morphine equivalent, clinicians should be diligent about treating these patients because they still are susceptible to OIC. 

    The three analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the placebo arms.  

    "With up to 90% of older patients receiving opioids to help cope with chronic pain, and up to 86% of them suffering from symptoms of OIC, these new analyses are particularly important in helping these patients achieve satisfactory control of their pain without the added burden of OIC. Older patients tend to be more susceptible to OIC due to comorbidities, polypharmacy, and reduced physical activity, and it is vital that they have access to therapies such as Movantik, that are shown to be effective in this challenging patient group." said Dr. Lynn Webster, Pain Researcher and Clinician and Senior Fellow at the Center of U.S. Policy.

    "There has been a shift in clinical practice to try to reduce doses of opioids used to treat chronic pain. However, low dose opioid therapy can prove to be equally troublesome in terms of treatment-related constipation as higher doses and it is important that physicians are diligent in monitoring for signs of OIC," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "This new analysis showing Movantik's efficacy irrespective of opioid dose is equally important in supporting the clinical shift to low dose opioid therapy through the management of OIC which can be expected in between 40-80% of patients taking chronic opioid therapy[1]."

    New Movantik (Naloxegol) Analyses Presented at PAINWeek 2021:

    Poster 1 (poster number 55):

    Naloxegol Provided Rapid Onset of Time to First Spontaneous Bowel Movement (SBM), Complete SBM and Predictable Efficacy in Older Adults (Age ≥ 65 Yrs): A Pooled Analysis of Two Phase 3 Studies

    Authors: Lynn Webster, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Martin Hale

    Poster 2 (poster number 59):

    Naloxegol Provided Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)

    Symptoms in Older Adults Age ≥ 65 Yrs: A Pooled Analysis of Two Phase 3 Studies

    Authors: Martin Hale, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Lynn Webster

    Poster 3 (poster number 30):

    Naloxegol Provides Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)

    Symptoms Irrespective of Opioid Dose: A Pooled Analysis of Two Phase 3 Studies

    Authors: Jeffrey Gudin, Jeremy A. Adler, June Almenoff, Carol B. Rockett, Enoch Bortey, Richard Rauck, Lynn Webster

    About RedHill Biopharma      

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[2], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[3], and Aemcolo® for the treatment of travelers' diarrhea in adults[4]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About Movantik® (naloxegol)

    Movantik® is an opioid antagonist indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Important Safety Information About Movantik

    Movantik® (naloxegol) is contraindicated in:

    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
    • Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.

    Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.

    Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

    Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Click here for the Medication Guide and full Prescribing Information for Movantik.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    MOVANTIK is a registered trademark of the AstraZeneca group of companies.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate and Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

    [2] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [3] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.      

    [4] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-presents-three-new-analyses-of-movantik-data-at-painweek-2021-301370121.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  8. RedHill Biopharma to Present at H.C. Wainwright Annual Global Investment and Cantor Global Healthcare Conferences

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 2, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September:

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT

    Speaker: Guy Goldberg, Chief Business Officer

    Cantor Global Healthcare Conference (September 27-30, 2021)

    Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay

    Moderator: Brandon…

    RedHill Biopharma to Present at H.C. Wainwright Annual Global Investment and Cantor Global Healthcare Conferences

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / September 2, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September:

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT

    Speaker: Guy Goldberg, Chief Business Officer

    Cantor Global Healthcare Conference (September 27-30, 2021)

    Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay

    Moderator: Brandon Folkes, CFA, Director, Equity Research - Healthcare, Biopharma

    Speaker: Guy Goldberg, Chief Business Officer

    The webcasts will be available for 30 days on the Company's website under the Investors page: www.redhillbio.com.

    RedHill Biopharma Ltd

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783
    fennell@consilium-comms.com

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd



    View source version on accesswire.com:
    https://www.accesswire.com/662533/RedHill-to-Present-at-HCW-Cantor-Conferences

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  9. TEL AVIV, Israel and RALEIGH, NC, Sept. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September:

    RedHill_Biopharma_Logo

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)
    Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT
    Speaker: Guy Goldberg, Chief Business Officer

    Cantor Global Healthcare Conference (September 27-30, 2021)
    Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay
    Moderator: Brandon Folkes, CFA, Director, Equity Research – Healthcare, Biopharma
    Speaker: Guy Goldberg, Chief Business Officer…

    TEL AVIV, Israel and RALEIGH, NC, Sept. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in September:

    RedHill_Biopharma_Logo

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT

    Speaker: Guy Goldberg, Chief Business Officer

    Cantor Global Healthcare Conference (September 27-30, 2021)

    Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay

    Moderator: Brandon Folkes, CFA, Director, Equity Research – Healthcare, Biopharma

    Speaker: Guy Goldberg, Chief Business Officer

    The webcasts will be available for 30 days on the Company's website under the Investors page: www.redhillbio.com.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults1, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

    1. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  
    2. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       
    3. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-to-present-at-hc-wainwright-annual-global-investment-and-cantor-global-healthcare-conferences-301368452.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  10. RedHill Biopharma Announces Two New U.S. Patents Covering Opaganib for Ebola Virus and RHB-104 for Crohn's

    U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035
    -
    Opaganib's 475-patient global Phase 2/3 study in severe COVID-19 approaching completion with upcoming top-line results
    -
    Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs for inflammatory and viral indications, including Ebola
    -
    Continued expansion of patent estate protecting RHB-104 following positive Phase 3 study for Crohn's disease; development path to approval being explored

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / August 23, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL

    RedHill Biopharma Announces Two New U.S. Patents Covering Opaganib for Ebola Virus and RHB-104 for Crohn's

    U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035
    -
    Opaganib's 475-patient global Phase 2/3 study in severe COVID-19 approaching completion with upcoming top-line results
    -
    Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs for inflammatory and viral indications, including Ebola
    -
    Continued expansion of patent estate protecting RHB-104 following positive Phase 3 study for Crohn's disease; development path to approval being explored

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / August 23, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued two new patents, one covering opaganib for treating Ebola virus disease, with patent protection until 2035, and the other covering RHB-104 for treating bacterial infections, with protection through 2029.

    'Opaganib's potent activity against several single-stranded RNA viruses positions it as a potential treatment for many viral diseases, including COVID-19 and other viruses that are the origin of devastating epidemics. Ebola virus disease remains a major risk with recent recurring outbreaks. Opaganib has already demonstrated positive results from non-clinical studies in Ebola, and RedHill is committed to continuing its development as a potential treatment for this devastating disease,' said Danielle T. Abramson, Ph.D., SVP, Global Head of Intellectual Property. 'In addition, we continue to evaluate the potential development path to approval of RHB-104 for Crohn's disease.'

    Opaganib is also under development for COVID-19, with a 475-patient global Phase 2/3 study in patients hospitalized with severe COVID-19 with patient treatment and follow-up recently completed and top-line results upcoming. In parallel, opaganib is also being studied in Phase 2 U.S. studies in cholangiocarcinoma and prostate cancer, as well as development programs for other indications.

    The MAP US randomized, double-blind, placebo-controlled first Phase 3 study with oral RHB-104 for Crohn's disease successfully met both its primary endpoint and its key secondary endpoints and presented the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn's disease, including anti-TNFs. Future development path to approval is being explored.

    About RedHill Biopharma
    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:
    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contact (U.S.):
    Bryan Gibbs
    Vice President
    Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com


    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd



    View source version on accesswire.com:
    https://www.accesswire.com/660878/RedHill-Announces-Two-New-US-Patents

    View Full Article Hide Full Article
  11. TEL AVIV, Israel and RALEIGH, N.C., Aug. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued two new patents, one covering opaganib for treating Ebola virus disease, with patent protection until 2035, and the other covering RHB-104 for treating bacterial infections, with protection through 2029.

    RedHill Biopharma Logo

    "Opaganib's potent activity against several single-stranded RNA viruses positions it as a potential treatment for many viral diseases, including COVID-19 and other viruses that are the origin of devastating epidemics. Ebola virus disease remains a major risk with recent recurring outbreaks. Opaganib…

    TEL AVIV, Israel and RALEIGH, N.C., Aug. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has issued two new patents, one covering opaganib for treating Ebola virus disease, with patent protection until 2035, and the other covering RHB-104 for treating bacterial infections, with protection through 2029.

    RedHill Biopharma Logo

    "Opaganib's potent activity against several single-stranded RNA viruses positions it as a potential treatment for many viral diseases, including COVID-19 and other viruses that are the origin of devastating epidemics. Ebola virus disease remains a major risk with recent recurring outbreaks. Opaganib has already demonstrated positive results from non-clinical studies in Ebola, and RedHill is committed to continuing its development as a potential treatment for this devastating disease," said Danielle T. Abramson, Ph.D., SVP, Global Head of Intellectual Property. "In addition, we continue to evaluate the potential development path to approval of RHB-104 for Crohn's disease."

    Opaganib is also under development for COVID-19, with a 475-patient global Phase 2/3 study in patients hospitalized with severe COVID-19 with patient treatment and follow-up recently completed and top-line results upcoming. In parallel, opaganib is also being studied in Phase 2 U.S. studies in cholangiocarcinoma and prostate cancer, as well as development programs for other indications.

    The MAP US randomized, double-blind, placebo-controlled first Phase 3 study with oral RHB-104 for Crohn's disease successfully met both its primary endpoint and its key secondary endpoints and presented the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn's disease, including anti-TNFs. Future development path to approval is being explored.

    About RedHill Biopharma      

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-two-new-us-patents-covering-opaganib-for-ebola-virus-and-rhb-104-for-crohns-301360447.html

    SOURCE RedHill Biopharma Ltd.

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  12. TEL AVIV, Israel and RALEIGH, NC, Aug. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its second quarter 2021 financial results and operational highlights on Thursday, August 26, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on Thursday, August 26, 2021, at 8:30 a.m. EDT, during which it will present key highlights.

    The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.  

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International…

    TEL AVIV, Israel and RALEIGH, NC, Aug. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its second quarter 2021 financial results and operational highlights on Thursday, August 26, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on Thursday, August 26, 2021, at 8:30 a.m. EDT, during which it will present key highlights.

    The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.  

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:

    +972-3-530-8845; the access code for the call is: 5554521 .

    About RedHill Biopharma    



    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® or opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783

    fennell@consilium-comms.com

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-to-host-second-quarter-2021-financial-results-and-operational-highlights-webcast-on-august-26-2021-301358734.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  13. RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Apotex

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 22, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ('AstraZeneca') and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. ('Apotex') resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application ('ANDA') seeking approval by the US. Food and Drug Administration ('FDA') to market a generic version of Movantik® (naloxegol).

    RedHill acquired from AstraZeneca in…

    RedHill Biopharma Announces Settlement of Movantik® Patent Litigation with Apotex

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 22, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ('AstraZeneca') and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. ('Apotex') resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application ('ANDA') seeking approval by the US. Food and Drug Administration ('FDA') to market a generic version of Movantik® (naloxegol).

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

    Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.

    The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to Apotex. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with Apotex does not end RedHill's ongoing litigation against the other one ANDA filer.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word "Reach" in the source column of the News Explorer pages of London Stock Exchange's website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

    SOURCE: RedHill Biopharma Ltd.



    View source version on accesswire.com:
    https://www.accesswire.com/656647/RedHill-Settles-MovantikR-Apotex-Patent-Litigation

    View Full Article Hide Full Article
  14. TEL AVIV, Israel and RALEIGH, NC, July 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ("AstraZeneca") and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. ("Apotex") resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

     

    RedHill Biopharma logo

     

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

    Under…

    TEL AVIV, Israel and RALEIGH, NC, July 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AstraZeneca AB and AstraZeneca Pharmaceuticals LP ("AstraZeneca") and Nektar Therapeutics have entered into a settlement and license agreement with Apotex, Inc. and Apotex Corp. ("Apotex") resolving their patent litigation in the U.S. in response to Apotex's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

     

    RedHill Biopharma logo

     

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

    Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.

    The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to Apotex. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with Apotex does not end RedHill's ongoing litigation against the other one ANDA filer.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib, a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

     

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.


     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com



    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-settlement-of-movantik-patent-litigation-with-apotex-301339505.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  15. RedHill Biopharma Significantly Extends Unrestricted Commercial Coverage for Talicia® with OptumRx

    Addition of Talicia® by OptumRx significantly extends Commercial patient access to Talicia® through this leader in U.S. healthcare

    Patient access to Talicia now extends to greater than 8 out of 10 covered U.S. Commercial lives

    Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies

    H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population

    TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 20, 2021

    RedHill Biopharma Significantly Extends Unrestricted Commercial Coverage for Talicia® with OptumRx

    Addition of Talicia® by OptumRx significantly extends Commercial patient access to Talicia® through this leader in U.S. healthcare

    Patient access to Talicia now extends to greater than 8 out of 10 covered U.S. Commercial lives

    Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies

    H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population

    TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 20, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that OptumRx, part of the UnitedHealth Group - a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021.

    'Momentum with Talicia is growing strongly and the addition of unrestricted Commercial coverage for Talicia by OptumRx, a major operator in U.S. healthcare coverage serving more than 26 million Americans, is an important advance in extending patient access to Talicia, which now extends to greater than 8 out of 10 covered U.S. Commercial lives,' said Rick Scruggs, RedHill's Chief Commercial Officer. 'Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment of H. pylori infection, and this listing represents the understanding within the medical community of the need to combat the high and growing resistance of H. pylori to commonly used antibiotics with an effective new first-line treatment.'

    About Talicia®
    Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the FDA and the World Health Organization (WHO) in recent years.

    Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[2] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[3].

    Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

    About H. pylori
    H. pylori is a bacterial infection that affects approximately 35%[4] of the U.S. population, with an estimated two million patients treated annually[5]. Worldwide, more than 50% of the population has
    H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[6] and a major risk factor for peptic ulcer disease[7] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[8]. More than 27,000 Americans are diagnosed with gastric cancer annually[9]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics commonly used in standard combination therapies[10].

    About RedHill Biopharma
    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[11], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[12], and Aemcolo® for the treatment of travelers' diarrhea in adults[13]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About OptumRx
    OptumRx provides a full spectrum of pharmacy care services through its network of more than 67,000 retail pharmacies, multiple home delivery, specialty and community health pharmacies and through the provision of in-home and pharmacy infusion services. OptumRx manages limited and ultra-limited distribution drugs in oncology, HIV, pain management and ophthalmology and serves the growing pharmacy needs of people with behavioral health and substance use disorders, particularly Medicare and Medicaid beneficiaries.

    OptumRx's comprehensive whole-person approach to pharmacy care services integrates demographic, medical, laboratory, pharmaceutical and other clinical data and applies analytics to drive clinical care insight to support care treatments and compliance, benefiting clients and individual consumers through enhanced services, elevated clinical quality and cost trend management.

    About Talicia® (omeprazole magnesium, amoxicillin and rifabutin)

    INDICATION AND USAGE
    Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial--, indicated for the treatment of Helicobacter pylori infection in adults.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

    IMPORTANT SAFETY INFORMATION
    Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.

    Talicia is contraindicated in patients receiving rilpivirine-containing products.

    Talicia is contraindicated in patients receiving delavirdine or voriconazole.

    Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.

    Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
    Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.

    Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.

    Talicia should not be used in patients with hepatic impairment or severe renal impairment.

    Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.

    The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

    To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
    1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Full prescribing information for Talicia is available at www.Talicia.com

    This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that Company will be unable to secure additional Pharmacy Benefit Management formulary coverage for Talicia®, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:
    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com
    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783
    fennell@consilium-comms.com

    [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. For full prescribing information see: www.Talicia.com.
    [2] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
    [3] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
    [4] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
    [5] IQVIA Custom Study for RedHill Biopharma, 2019
    [6] Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
    [7] NIH - Helicobacter pylori and Cancer, September 2013.
    [8] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
    [9] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
    [10] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
    [11] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
    [12] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
    [13] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd.



    View source version on accesswire.com:
    https://www.accesswire.com/656250/RedHill-Extends-Talicia-Commercial-Coverage

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  16. TEL-AVIV, Israel and RALEIGH, N.C., July 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that OptumRx, part of the UnitedHealth Group - a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021.

     

    RedHill Biopharma Logo

     

    "Momentum with Talicia is growing strongly and the addition of unrestricted Commercial coverage for Talicia by OptumRx, a major operator in U.S. healthcare coverage serving more than 26 million Americans, is an important advance…

    TEL-AVIV, Israel and RALEIGH, N.C., July 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that OptumRx, part of the UnitedHealth Group - a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021.

     

    RedHill Biopharma Logo

     

    "Momentum with Talicia is growing strongly and the addition of unrestricted Commercial coverage for Talicia by OptumRx, a major operator in U.S. healthcare coverage serving more than 26 million Americans, is an important advance in extending patient access to Talicia, which now extends to greater than 8 out of 10 covered U.S. Commercial lives," said Rick Scruggs, RedHill's Chief Commercial Officer. "Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment of H. pylori infection, and this listing represents the understanding within the medical community of the need to combat the high and growing resistance of H. pylori to commonly used antibiotics with an effective new first-line treatment."   



    About Talicia®             

    Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the FDA and the World Health Organization (WHO) in recent years.

    Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[2] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[3].        



    Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

    About H. pylori         

    H. pylori is a bacterial infection that affects approximately 35%[4] of the U.S. population, with an estimated two million patients treated annually[5]. Worldwide, more than 50% of the population has

    H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[6] and a major risk factor for peptic ulcer disease[7] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[8]. More than 27,000 Americans are diagnosed with gastric cancer annually[9]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics commonly used in standard combination therapies[10].

    About RedHill Biopharma  

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[11], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[12], and Aemcolo® for the treatment of travelers' diarrhea in adults[13]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

    About OptumRx

    OptumRx provides a full spectrum of pharmacy care services through its network of more than 67,000 retail pharmacies, multiple home delivery, specialty and community health pharmacies and through the provision of in-home and pharmacy infusion services. OptumRx manages limited and ultra-limited distribution drugs in oncology, HIV, pain management and ophthalmology and serves the growing pharmacy needs of people with behavioral health and substance use disorders, particularly Medicare and Medicaid beneficiaries.

    OptumRx's comprehensive whole-person approach to pharmacy care services integrates demographic, medical, laboratory, pharmaceutical and other clinical data and applies analytics to drive clinical care insight to support care treatments and compliance, benefiting clients and individual consumers through enhanced services, elevated clinical quality and cost trend management.

    About Talicia® (omeprazole magnesium, amoxicillin and rifabutin)

    INDICATION AND USAGE         

    Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults.        

               

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 

    IMPORTANT SAFETY INFORMATION

    Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.

    Talicia is contraindicated in patients receiving rilpivirine-containing products.

    Talicia is contraindicated in patients receiving delavirdine or voriconazole.

    Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.

    Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.

    Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.

    Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.

    Talicia should not be used in patients with hepatic impairment or severe renal impairment.

    Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.

    The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

    To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at

    1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.  

    Full prescribing information for Talicia is available at www.Talicia.com

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that Company will be unable to secure additional Pharmacy Benefit Management formulary coverage for Talicia®, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com


    [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. For full prescribing information see: www.Talicia.com.

    [2] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.

    [3] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).

    [4] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.

    [5] IQVIA Custom Study for RedHill Biopharma, 2019

    [6] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.

    [7] NIH – Helicobacter pylori and Cancer, September 2013.

    [8] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.

    [9] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).

    [10] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.

    [11] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [12] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [13] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-significantly-extends-unrestricted-commercial-coverage-for-talicia-with-optumrx-301337226.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  17. RedHill Biopharma Announces Last Patient Out for Phase 2/3 COVID-19 Study of Oral Opaganib

    Patient follow-up completed for the 475-patient global Phase 2/3 study of oral opaganib for severe COVID-19
    Top-line results expected in the coming weeks

    Opaganib, a novel, dual antiviral and anti-inflammatory investigational COVID-19 pill, demonstrated potent inhibition of Beta and Gamma variants and is expected to be effective against emerging variants, including Delta and Delta Plus

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 19, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and…

    RedHill Biopharma Announces Last Patient Out for Phase 2/3 COVID-19 Study of Oral Opaganib

    Patient follow-up completed for the 475-patient global Phase 2/3 study of oral opaganib for severe COVID-19
    Top-line results expected in the coming weeks

    Opaganib, a novel, dual antiviral and anti-inflammatory investigational COVID-19 pill, demonstrated potent inhibition of Beta and Gamma variants and is expected to be effective against emerging variants, including Delta and Delta Plus

    TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / July 19, 2021 / RedHill Biopharma Ltd. (NASDAQ:RDHL) ('RedHill' or the 'Company'), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640) [1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line results are expected in the coming weeks.

    Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19. Opaganib recently demonstrated potent in vitro inhibition of the Beta (South African) and Gamma (Brazilian) variants and based on its unique host-targeted mechanism and the preliminary results from this study, we believe opaganib is likely to also maintain its activity against emerging variants, including Delta and Delta Plus . Positive U.S. Phase 2 efficacy data has also previously been announced.

    'Emerging data is showing that variants are capable of evading vaccines' effects. Not only does this threaten efforts to control the pandemic, but it also brings into sharp focus the urgent need for effective oral COVID-19 therapies capable of working despite the emergence of variants. This makes the completion of this study even more significant, given its potential to be a game-changer in the treatment of COVID-19,' said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill . 'We can now concentrate on getting all the data collected, cleaned and collated in the database ready for analysis and subsequent reporting. This means we are weeks away from knowing if we are a big step closer to having a paradigm-shifting oral therapy for hospitalized COVID-19 patients.'

    The primary endpoint of the global Phase 2/3 study, approved in 10 countries, is the proportion of patients breathing room air without oxygen support by Day 14. The study has also captured additional important outcome measures, such as the time to hospital discharge, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality.

    Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations [2] . Furthermore, four independent DSMB recommendations to continue the study have been received following three unblinded safety reviews and an unblinded futility analysis. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.

    The Company maintains ongoing discussions with the FDA, EMA and other regulators, on potential pathways to approval, with next steps to be guided by study results. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries.

    About Opaganib (ABC294640 [3] )

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study that has now completed patient treatment and follow-up. Opaganib has also demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa -induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids [4] .

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov , a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik ® for opioid-induced constipation in adults [5] , Talicia ® for the treatment of Helicobacter pylori (H. pylori) infection in adults [6] , and Aemcolo ® for the treatment of travelers' diarrhea in adults [7] . RedHill's key clinical late-stage development programs include: (i) RHB-204 , with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640) , a first - in - class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat) , a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104 , with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda ® ) , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB - 106 , an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia ® ; (v) the Company's ability to successfully commercialize and promote Movantik ® , Talicia ® and Aemcolo ® ; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:
    Adi Frish
    Chief Corporate & Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    adi@redhillbio.com

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236
    bryan.gibbs@finnpartners.com
    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783
    fennell@consilium-comms.com

    [1] Opaganib is an investigational new drug, not available for commercial distribution.
    [2] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-hear comparison study.
    [3] Yeliva remains the prospective brand name for opaganib
    [4] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
    [5] Full prescribing information for Movantik ® (naloxegol) is available at: www.Movantik.com.
    [6] Full prescribing information for Talicia ® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com .
    [7] Full prescribing information for Aemcolo ® (rifamycin) is available at: www.Aemcolo.com.

    This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com .

    SOURCE: RedHill Biopharma Ltd.



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  18. TEL AVIV, Israel and RALEIGH, NC, July 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line results are expected in the coming weeks.

    RedHill Biopharma logo

    Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19. Opaganib recently demonstrated potent in vitro inhibition of the Beta (South African) and…

    TEL AVIV, Israel and RALEIGH, NC, July 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line results are expected in the coming weeks.

    RedHill Biopharma logo

    Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19. Opaganib recently demonstrated potent in vitro inhibition of the Beta (South African) and Gamma (Brazilian) variants and based on its unique host-targeted mechanism and the preliminary results from this study, we believe opaganib is likely to also maintain its activity against emerging variants, including Delta and Delta Plus. Positive U.S. Phase 2 efficacy data has also previously been announced.

    "Emerging data is showing that variants are capable of evading vaccines' effects. Not only does this threaten efforts to control the pandemic, but it also brings into sharp focus the urgent need for effective oral COVID-19 therapies capable of working despite the emergence of variants. This makes the completion of this study even more significant, given its potential to be a game-changer in the treatment of COVID-19," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "We can now concentrate on getting all the data collected, cleaned and collated in the database ready for analysis and subsequent reporting. This means we are weeks away from knowing if we are a big step closer to having a paradigm-shifting oral therapy for hospitalized COVID-19 patients."

    The primary endpoint of the global Phase 2/3 study, approved in 10 countries, is the proportion of patients breathing room air without oxygen support by Day 14. The study has also captured additional important outcome measures, such as the time to hospital discharge, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality.

    Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[2]. Furthermore, four independent DSMB recommendations to continue the study have been received following three unblinded safety reviews and an unblinded futility analysis. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.

    The Company maintains ongoing discussions with the FDA, EMA and other regulators, on potential pathways to approval, with next steps to be guided by study results. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries. 

    About Opaganib (ABC294640[3])

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study that has now completed patient treatment and follow-up. Opaganib has also demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[4].

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo® for the treatment of travelers' diarrhea in adults[7]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-hear comparison study.

    [3] Yeliva remains the prospective brand name for opaganib

    [4] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [5] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [6] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.        

    [7] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

     

     

    Cision View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-last-patient-out-for-phase-23-covid-19-study-of-oral-opaganib-301336304.html

    SOURCE RedHill Biopharma Ltd.

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  19. TEL-AVIV, Israel and RALEIGH, N.C., July 13, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, has added Movantik® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation (OIC), as a preferred brand with no restrictions to a National Formulary and as a preferred brand on its other commercial formularies starting July 1, 2021.

    RedHill Biopharma logo

    "Chronic pain is a major public health issue and the debilitating constipation that often accompanies treatment with opioids only serves to compound the issue. It…

    TEL-AVIV, Israel and RALEIGH, N.C., July 13, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, has added Movantik® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation (OIC), as a preferred brand with no restrictions to a National Formulary and as a preferred brand on its other commercial formularies starting July 1, 2021.

    RedHill Biopharma logo

    "Chronic pain is a major public health issue and the debilitating constipation that often accompanies treatment with opioids only serves to compound the issue. It is important for optimal therapy that patients have access to treatments such as Movantik, the market-leading PAMORA for opioid-induced constipation," said Rick Scruggs, RedHill's Chief Commercial Officer. "This important new listing as an unrestricted preferred brand strengthens Movantik's leadership position and now means that over 30 million more Americans will have access to Movantik. Almost 9 out of 10 U.S. commercial lives are now covered and we continue to work toward additional formulary coverage for the remaining patients."  

    About Movantik® (naloxegol)

    Movantik® is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Important Safety Information About Movantik

    Movantik® (naloxegol) is contraindicated in:

    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
    • Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.

    Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.

    Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Post-marketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

    Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Click here for the Medication Guide and full Prescribing Information for Movantik.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    MOVANTIK is a registered trademark of the AstraZeneca group of companies.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[i], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[ii], and Aemcolo® for the treatment of travelers' diarrhea in adults[iii]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.  

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will be unable to secure additional PBMs formulary coverage for Movantik,; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.


    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

    [i] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    [ii] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    [iii] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  20. TEL AVIV, Israel and RALEIGH, N.C., June 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing potent inhibition of COVID-19 variants of concern by opaganib (Yeliva®, ABC294640)[1].

    Opaganib, a leading novel investigational oral pill in development for the treatment of COVID-19, is a unique host-targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. It exerts its antiviral effect by selectively inhibiting sphingosine kinase-2 (SK2), a key enzyme produced in human cells that can be recruited by the virus to support its replication. Following the recently presented positive U.S. Phase 2 study data, opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 is fully enrolled and is expected to be completed in the coming weeks.

    Working with the University of Louisville Center for Predictive Medicine, opaganib was studied in a 3D tissue model of human bronchial epithelial cells (EpiAirway™) to evaluate the in vitro efficacy of opaganib in inhibiting the Beta (South African) and Gamma (Brazilian) SARS-CoV-2 variants. Preliminary results showed potent inhibition of both the Beta and Gamma variants by opaganib at non-cytotoxic doses.

    "The results we have seen with opaganib so far are exciting," said William Severson, Ph.D., Director of Shared Resources for the Center for Predictive Medicine, University of Louisville. "They provide further evidence in support of opaganib's antiviral capabilities and highlight opaganib's potential as an orally-administered treatment for COVID-19 and its continuously emerging variants."

    "Opaganib inhibits an enzyme in the COVID-19 patients' cells called sphingosine kinase-2, which the SARS-CoV-2 virus can recruit in order to replicate," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Opaganib's dual antiviral and anti-inflammatory mechanism of action is independent of mutations in the spike protein. This means we expect opaganib to similarly work against other emerging COVID-19 variants, including the Delta (Indian) variant. Moreover, we are looking forward to seeing the top-line clinical data from the global Phase 2/3 study which is expected to be completed in the coming weeks."

    The global Phase 2/3 study of opaganib in COVID-19 has previously received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[2].

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in preliminary top-line data from the 40-patient U.S. Phase 2 study.

    Opaganib demonstrated potent inhibition of viral replication against SARS-CoV-2, the virus that causes COVID-19, in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.           

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in last patient visit and top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

     

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-head comparison study.

    [3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

     

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    SOURCE RedHill Biopharma Ltd

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  21. TEL AVIV, Israel and RALEIGH, N.C., June 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish, RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO Digital International Convention, taking place June 14-18, 2021.

    RedHill Biopharma Logo

    The presentation will be available on the Company's website for 30 days from the start of the conference: https://ir.redhillbio.com.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced…

    TEL AVIV, Israel and RALEIGH, N.C., June 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish, RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO Digital International Convention, taking place June 14-18, 2021.

    RedHill Biopharma Logo

    The presentation will be available on the Company's website for 30 days from the start of the conference: https://ir.redhillbio.com.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-to-present-at-the-bio-digital-international-convention-301308802.html

    SOURCE RedHill Biopharma Ltd.

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  22. TEL AVIV, Israel and RALEIGH, NC, June 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has completed enrollment and randomized the last patient in the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). A total of 475 patients were randomized, more than the planned 464.

    RedHill Biopharma logo

    The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14. The study captures additional important outcome measures in the follow up period of up to 6 weeks, such as the time to hospital discharge, improvement according to the World Health…

    TEL AVIV, Israel and RALEIGH, NC, June 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has completed enrollment and randomized the last patient in the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). A total of 475 patients were randomized, more than the planned 464.

    RedHill Biopharma logo

    The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14. The study captures additional important outcome measures in the follow up period of up to 6 weeks, such as the time to hospital discharge, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality.

    An evaluation of the blinded blended intubation and mortality rates to date is encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[2]. Furthermore, four independent DSMB recommendations to continue the study were already provided following unblinded safety and futility reviews.

    "Enrollment completion of this 475-patient global study of oral opaganib for COVID-19 is a truly exciting milestone in the urgent search for an effective pill to treat COVID-19, positioning opaganib as a leading novel, dual-action, investigational COVID-19 oral treatment," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "Acting on the cause and effect of COVID-19 through a dual antiviral and anti-inflammatory effect, opaganib is host-targeted and is therefore expected to be effective against emerging viral variants. With waves of COVID-19 continuing to wash over many countries, coupled with the specter of new variants, it is more critical than ever that the world has access to an oral pill to treat COVID-19."

    In addition to ongoing discussions with the FDA and other regulators, the Company has also met with the EMA to talk about a European pathway. As with all discussions with regulatory bodies, next steps will be guided by study results. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries. 

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in last patient visit and top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-hear comparison study.

    [3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  23. RALEIGH, NC / ACCESSWIRE / May 27, 2021 / The Summer Solstice - Best Ideas from the Buy-Side will take place on June 1-4, 2021, where 35 SmallCap, MicroCap and NanoCap public companies will be presenting via virtual webcast to a global investor audience.

    The Summer Solstice - Best Ideas from the Buy Side: VIRTUAL begins on Tuesday, June 1, 2021, with company presentations beginning at 9am Eastern Time. Presentations will be webcast on Tuesday and Wednesday (June 1 and 2) with 1x1 Meetings being held on Thursday and Friday (June 3 and 4).

    Join us for a full two days of presentations that were nominated by qualified investors as a "Best Idea." A full agenda is located here: https://microcaprodeo.com/agenda

    If you would like to attend and participate…

    RALEIGH, NC / ACCESSWIRE / May 27, 2021 / The Summer Solstice - Best Ideas from the Buy-Side will take place on June 1-4, 2021, where 35 SmallCap, MicroCap and NanoCap public companies will be presenting via virtual webcast to a global investor audience.

    The Summer Solstice - Best Ideas from the Buy Side: VIRTUAL begins on Tuesday, June 1, 2021, with company presentations beginning at 9am Eastern Time. Presentations will be webcast on Tuesday and Wednesday (June 1 and 2) with 1x1 Meetings being held on Thursday and Friday (June 3 and 4).

    Join us for a full two days of presentations that were nominated by qualified investors as a "Best Idea." A full agenda is located here: https://microcaprodeo.com/agenda

    If you would like to attend and participate in the Summer Solstice - Best Ideas from the Buy-Side Virtual Conference, please register here to listen to every webcast directly on the website and book 1x1 meetings with presenting companies: https://microcaprodeo.com/signup

    Full event website: https://microcaprodeo.com/

    On Tuesday June 1, 2021 and Wednesday, June 2, 2021, the following issuers will be presenting their companies virtually. Below are the webcasting links to view presentations.

    Date

    Time

    Presentation Name

    Ticker

    Event URL

    Tuesday, June 1st

    8:30 - 8:55

    RedHill Biopharma

    RDHL

    https://www.webcaster4.com/Webcast/Page/2134/41529

    Tuesday, June 1st

    9:00-9:25

    Photocure

    PHO

    https://www.webcaster4.com/Webcast/Page/2134/41489

    Tuesday, June 1st

    9:30-9:55

    electroCure

    ECOR

    https://www.webcaster4.com/Webcast/Page/2134/41494

    Tuesday, June 1st

    10:00-10:25

    Mechanical Technology, Inc.

    MKTY

    https://www.webcaster4.com/Webcast/Page/2134/41496

    Tuesday, June 1st

    10:30-10:55

    Stabillis Solutions, Inc.

    SLNG

    https://www.webcaster4.com/Webcast/Page/2134/41497

    Tuesday, June 1st

    11:00-11:25

    CECO Environmental Corp

    CECE

    https://www.webcaster4.com/Webcast/Page/2134/41500

    Tuesday, June 1st

    11:30-11:55

    Monaker Group

    MKGI

    https://www.webcaster4.com/Webcast/Page/2134/41508

    Tuesday, June 1st

    12:00-12:25

    Auddia Inc.

    AUUD

    https://www.webcaster4.com/Webcast/Page/2134/41509

    Tuesday, June 1st

    12:30-12:55

    Assure Holdings

    ARHH

    https://www.webcaster4.com/Webcast/Page/2134/41510

    Tuesday, June 1st

    1:00-1:25

    Dolphin Entertainment

    DLPN

    https://www.webcaster4.com/Webcast/Page/2134/41511

    Tuesday, June 1st

    1:30-1:55

    IMAC Holdings

    IMAC

    https://www.webcaster4.com/Webcast/Page/2134/41512

    Tuesday, June 1st

    2:00-2:25

    COMSovereign

    COMS

    https://www.webcaster4.com/Webcast/Page/2134/41513

    Tuesday, June 1st

    2:30-2:55

    Myomo

    MYO

    https://www.webcaster4.com/Webcast/Page/2134/41514

    Tuesday, June 1st

    3:00-3:25

    Pivotal Systems

    PVS

    https://www.webcaster4.com/Webcast/Page/2134/41604

    Tuesday, June 1st

    3:30-3:55

    Miravo Healthcare

    MRVFF

    https://www.webcaster4.com/Webcast/Page/2134/41516

    Tuesday, June 1st

    4:00-4:25

    NZME

    NZME

    https://www.webcaster4.com/Webcast/Page/2134/41517

    Tuesday, June 1st

    4:30-4:55

    Zoom Telephonics dba Minim

    MINM

    https://www.webcaster4.com/Webcast/Page/2134/41518

    Tuesday, June 1st

    5:00 - 5:25

    DataStorage Corp

    DTST

    https://www.webcaster4.com/Webcast/Page/2134/41527

    Wednesday, June 2nd

    8:30-8:55

    NLS Pharmaceuticals

    NLSP

    https://www.webcaster4.com/Webcast/Page/2134/41515

    Wednesday, June 2nd

    9:00-9:25

    Aspira Women's Health

    AWH

    https://www.webcaster4.com/Webcast/Page/2134/41499

    Wednesday, June 2nd

    9:30-9:55

    Issuer Direct (ISDR)

    ISDR

    https://www.webcaster4.com/Webcast/Page/2134/41502

    Wednesday, June 2nd

    10:00-10:25

    Biomerica

    BMRA

    https://www.webcaster4.com/Webcast/Page/2134/41504

    Wednesday, June 2nd

    10:30-10:55

    Alimera Sciences

    ALIM

    https://www.webcaster4.com/Webcast/Page/2134/41505

    Wednesday, June 2nd

    11:00-11:25

    LifeMD

    LFMD

    https://www.webcaster4.com/Webcast/Page/2134/41603

    Wednesday, June 2nd

    11:30-11:55

    Stryve Foods, LLC

    ANDA

    https://www.webcaster4.com/Webcast/Page/2134/41507

    Wednesday, June 2nd

    12:00-12:25

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    BIOL

    https://www.webcaster4.com/Webcast/Page/2134/41519

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    CALL:L

    https://www.webcaster4.com/Webcast/Page/2134/41520

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    FBIO

    https://www.webcaster4.com/Webcast/Page/2134/41521

    Wednesday, June 2nd

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    https://www.webcaster4.com/Webcast/Page/2134/41522

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    MLSS

    https://www.webcaster4.com/Webcast/Page/2134/41523

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    https://www.webcaster4.com/Webcast/Page/2134/41525

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    Contact Information:
    Angie Goertz, Vice President of Marketing
    Issuer Direct Corporation
    Office: (919) 228-6240
    Email: Angie.Goertz@IssuerDirect.com

    SOURCE: MicroCap Rodeo



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  24. TEL AVIV, Israel and RALEIGH, N.C., May 27, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the first quarter ended March 31, 2021.

    RedHill Biopharma Logo

    Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The progress of our two novel, oral COVID-19 programs has put RedHill at the forefront of oral COVID-19 therapeutics development. Opaganib, one of the most advanced and promising novel, dual-mode of action, oral drug candidates in development for COVID-19, now has almost 100% enrollment in its global 464-patient Phase 2/3 study in severe COVID-19." Mr. Ben-Asher continued: "Commercially, a strong end to the first…

    TEL AVIV, Israel and RALEIGH, N.C., May 27, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the first quarter ended March 31, 2021.

    RedHill Biopharma Logo

    Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The progress of our two novel, oral COVID-19 programs has put RedHill at the forefront of oral COVID-19 therapeutics development. Opaganib, one of the most advanced and promising novel, dual-mode of action, oral drug candidates in development for COVID-19, now has almost 100% enrollment in its global 464-patient Phase 2/3 study in severe COVID-19." Mr. Ben-Asher continued: "Commercially, a strong end to the first quarter has set up 2021 for growth, reversing a slow start to the year across the industry. Movantik's new prescriptions in the first quarter outperformed the same quarter last year, while Talicia's growth in prescription volume, repeat prescribing and new prescribers will be key growth drivers going forward. With the U.S. now emerging from the shadows of COVID-19, patients returning to clinics and travel resuming, positively affecting Aemcolo's prospects, we are excited for the promise 2021 holds."   

    Micha Ben Chorin, Chief Financial Officer at RedHill, added: "A strong March helped rebalance quarterly revenues, as we maintained cash burn rate at previous quarter levels. With a healthy balance sheet, we are well-positioned to drive our late-stage R&D programs forward, as we work diligently to build on the upward trends across our core business." 

    Financial highlights for the quarter ended March 31, 2021[iii]

    Net Revenues were approximately $20.6 million for the first quarter of 2021, a decrease of $0.9 million compared to the fourth quarter of 2020. The decrease was mainly attributable to typical cyclical trends in Movantik sales.

    Gross Profit was approximately $10.3 million for the first quarter of 2021, a decrease of $0.5 million compared to the fourth quarter of 2020, maintaining a consistent gross margin of approximately 50%. The decrease was mainly attributable to the decrease in net revenues.

    Research and Development Expenses were approximately $7.5 million for the first quarter of 2021, an increase of $1.3 million compared to the fourth quarter of 2020, mainly attributable to the progression of our COVID-19 development programs.

    Selling, Marketing and General and Administrative Expenses were approximately $21.0 million for the first quarter of 2021, a decrease of $3.3 million compared to the fourth quarter of 2020. The decrease was mainly attributable to large non-recurring marketing investments made in the fourth quarter of 2020.

    Operating Loss and Net Loss were approximately $18.2 million and $22.9 million, respectively, for the first quarter of 2021, compared to $19.7 million and $24.3 million, respectively, in the fourth quarter of 2020. The decrease was mainly attributable to the decrease in marketing expenses, as detailed above.

    Net Cash Used in Operating Activities was approximately $12.3 million for the first quarter of 2021, a decrease of $0.4 million compared to the fourth quarter of 2020.

    Net Cash Provided by Financing Activities was approximately $58.7 million for the first quarter of 2021, comprised primarily of proceeds from equity offerings.

    Cash Balance1 as of March 31, 2021, was approximately $92.1 million.

    Commercial Highlights

    Movantik® (naloxegol)[iv]

    Movantik ended the quarter strongly with a 4% increase in new prescriptions compared to the first quarter of 2020. Movantik market leadership position is holding strong at 75% U.S. market share, with focus on growth in 2021 and beyond. Movantik also continues to enjoy excellent coverage without restrictions in the PAMORA class for both commercial & government segments, with 88% of American commercial lives covered.

    In March 2021, the Company announced that RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP and Nektar Therapeutics had entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. (MSN) resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application (ANDA) seeking approval by the U.S. Food and Drug Administration (FDA) to market a generic version of Movantik. Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to FDA approval) or earlier under certain circumstances.

    In February 2021, the Company also announced an agreement with Cosmo Pharmaceuticals N.V. to manufacture Movantik, securing high-quality manufacturing capacity for our current largest commercial product.

    Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[v]

    Talicia continued to achieve new launch year milestones. Talicia achieved 11% growth in prescription volume and a 39% increase in the number of repeat prescribers compared to the previous quarter, positioning the brand and RedHill for continued growth in 2021 as clinician visits resume and diagnostic labs reopen fully. The quarter ended strongly, resulting in the highest levels of monthly and weekly prescription volume and number of prescribers since launch. Overall, Talicia continues to show growth in total prescribers and repeat prescribing, and March's performance indicates ongoing momentum for accelerated growth for the remainder of 2021.  

    Talicia's growth is supported by an increased commercial coverage of 77%, compared to 69% in the fourth quarter of 2020. Further formulary additions are expected, adding to the previously announced listings of Talicia on the national formularies of Prime Therapeutics, EnvisionRx and Express Scripts.

    Aemcolo® (rifamycin)[vi]

    RedHill has implemented plans, including re-launching active field promotion, to support, and build on, the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. The Company expects that these plans will drive a resurgence of interest in Aemcolo once travel restrictions are lifted and international travel from the U.S. returns to significant levels.

    In January 2021, the Company reported that its partner, Cosmo Pharmaceuticals, announced it had successfully completed its Phase 2 Proof-of-Concept (POC) clinical trial of rifamycin SV-MMX 600 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). As part of an exclusive license agreement between RedHill and Cosmo Pharmaceuticals from October 2019 for the U.S. rights to Aemcolo (rifamycin), RedHill maintains certain rights, including a right of first refusal, in relation to rifamycin SV-MMX 600 mg in the U.S.

    R&D Highlights

    COVID-19 Program: Opaganib (ABC294640, Yeliva®)[vii] 

    The global Phase 2/3 study of orally-administered, opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840) is now almost 100% enrolled. Last patient out will occur approximately six weeks after the final patient is randomized. This puts opaganib amongst the first novel investigational COVID-19 oral pills to deliver late-stage data.

    The study has passed four Data Safety Monitoring Board reviews, including a futility review. The fourth DSMB review, conducted in April, was based on an analysis of unblinded safety data from the first 255 patients treated for at least 14 days, extending the total opaganib safety database to approximately 380 patients.

    Opaganib has shown dual anti-inflammatory and antiviral activity and is host-targeted, and therefore expected to be effective against emerging viral variants with various mutations in the spike protein.

    The Company recently announced receipt of a Notice of Allowance for a U.S. patent application covering the use of opaganib for the treatment of COVID-19 with a term extending until at least 2041. The Company also previously announced that it had signed collaborations with several U.S., European and Canadian suppliers, including with Cosmo Pharmaceuticals for large-scale ramp-up of opaganib manufacturing, further strengthening manufacturing capabilities and capacity of opaganib.

    In view of the upcoming completion of enrollment, RedHill is evaluating the regulatory path for opaganib with a focus on those countries currently most affected by COVID-19. The regulatory path, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive, as well as the specific requirements in each country. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has indicated we will need to complete additional studies to support applications in the U.S. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.

    The Company continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the development and manufacturing scale-up of opaganib.

    COVID-19 Program: RHB-107 (upamostat)[viii]

    In February 2021, RedHill announced dosing of the first patient in the U.S. Phase 2/3 COVID-19 study with novel, orally-administered, RHB-107 (upamostat). The study with once-daily RHB-107 is evaluating treatment of non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen - the vast majority of COVID-19 patients.

    RHB-107 is a novel, orally-administered, serine protease inhibitor. It is also host-targeting and therefore also expected to be effective against emerging viral variants with mutations in the spike protein. In previously announced in vitro results, RHB-107 strongly inhibited SARS-CoV-2 viral replication.

    The Company recently announced receipt of a Notice of Allowance for a U.S. patent application covering the use of RHB-107 for the treatment of COVID-19 with a term extending until at least 2041. 

    RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease      

    A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection.

    The FDA also granted Fast Track designation for RHB-204 in January 2021, providing early and frequent communications and a rolling review of any New Drug Application (NDA). RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

    RHB-204 was granted FDA Orphan Drug designation and Qualified Infectious Disease Product designation, extending its U.S. market exclusivity to a potential total of 12 years upon potential FDA approval.

    Opaganib - Cholangiocarcinoma and Prostate Cancer

    The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is ongoing for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.

    In light of preclinical findings demonstrating tumor regression following combination treatment with opaganib and RHB-107 (upamostat), RedHill plans to add an additional cohort to the ongoing Phase 2a study, evaluating opaganib in combination with RHB-107, subject to discussions with the FDA. Opaganib was granted FDA Orphan Drug designation for the treatment of cholangiocarcinoma.

    An additional Phase 2 study with opaganib in prostate cancer is ongoing at the Medical University of South Carolina (MUSC). The study is supported by a National Cancer Institute grant awarded to MUSC with additional support from RedHill.

    Conference Call and Webcast Information:

    The Company will host a webcast today, Thursday, May 27, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2021.

    The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.                  

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:

    +972-3-530-8845; the access code for the call is: 8506238.

    About RedHill Biopharma      

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding planned commercial operational breakeven by the end of 2021 and regarding achieving fast growth and increased profit margin. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a delay in completion of enrollment for the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107, delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required, and for RHB-107 may be required, by regulatory authorities to support such potential applications and the use or marketing of opaganib and/or RHB-107, as the case may be, for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate and Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com



     

     

     

    REDHILL BIOPHARMA LTD.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

    (Unaudited)

















    Three Months Ended





    March 31, 





    2021



    2020





    U.S. dollars in thousands

    NET REVENUES



    20,575



    1,056

    COST OF REVENUES



    10,253



    1,715

    GROSS PROFIT



    10,322



    (659)

    RESEARCH AND DEVELOPMENT EXPENSES



    7,484



    2,765

    SELLING AND MARKETING EXPENSES



    13,895



    9,006

    GENERAL AND ADMINISTRATIVE EXPENSES



    7,095



    4,586

    OPERATING LOSS



    18,152



    17,016

    FINANCIAL INCOME



    (42)



    (214)

    FINANCIAL EXPENSES



    4,753



    355

    FINANCIAL EXPENSES, net



    4,711



    141

    LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD



    22,863



    17,157











    LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):



    0.05



    0.05

    WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands)



    429,603



    352,696

     

     

    REDHILL BIOPHARMA LTD.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

















    March 31,



    December 31,





    2021



    2020





    Unaudited            Audited





    U.S. dollars in thousands

    CURRENT ASSETS:









    Cash and cash equivalents



    75,972



    29,295

    Bank deposits



    16



    17

    Financial assets at fair value through profit or loss





    481

    Trade receivables



    23,306



    28,655

    Prepaid expenses and other receivables



    4,094



    5,521

    Inventory



    9,270



    6,526





    112,658



    70,495

    NON-CURRENT ASSETS:









    Restricted cash



    16,158



    16,164

    Fixed assets



    553



    511

    Right-of-use assets



    4,702



    5,192

    Intangible assets



    86,052



    87,879





    107,465



    109,746

    TOTAL ASSETS



    220,123



    180,241





















    CURRENT LIABILITIES: 









    Accounts payable



    6,536



    11,553

    Lease liabilities



    1,636



    1,710

    Allowance for deductions from revenue



    22,677



    18,343

    Accrued expenses and other current liabilities



    25,446



    24,082

    Payable in respect of intangible assets purchase



    10,334



    17,547





    66,629



    73,235











    NON-CURRENT LIABILITIES:









    Borrowing



    82,524



    81,386

    Payable in respect of intangible assets purchase



    13,788



    7,199

    Lease liabilities



    3,391



    3,807

    Royalty obligation



    750



    750





    100,453



    93,142

    TOTAL LIABILITIES



    167,082



    166,377











    EQUITY:









    Ordinary shares



    1,309



    1,054

    Additional paid-in capital



    354,057



    293,144

    Accumulated deficit



    (302,325)



    (280,334)

    TOTAL EQUITY



    53,041



    13,864

    TOTAL LIABILITIES AND EQUITY



    220,123



    180,241

     

     

    REDHILL BIOPHARMA LTD.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

    (Unaudited)



















    Three Months Ended







    March 31, 







    2021



    2020







    U.S. dollars in thousands

    OPERATING ACTIVITIES:











    Comprehensive loss



    (22,863)



    (17,157)



    Adjustments in respect of income and expenses not involving cash flow:











    Share-based compensation to employees and service providers



    872



    802



    Depreciation



    492



    350



    Amortization and impairment of intangible assets



    1,827



    1,076



    Non-cash interest expenses related to borrowing and payable in respect of intangible assets purchase



    2,639



    104



    Fair value losses (gains) on financial assets at fair value through profit or loss



    6



    75



    Exchange differences and revaluation of bank deposits



    46



    (159)







    5,882



    2,248



    Changes in assets and liability items:











    Decrease (increase) in trade receivables



    5,349



    (501)



    Decrease in prepaid expenses and other receivables



    1,428



    971



    Increase in inventories



    (2,744)



    (885)



    Decrease in accounts payable



    (5,017)



    (999)



    Increase in accrued expenses and other liabilities



    1,364



    6,030



    Increase (decrease) in allowance for deductions from revenue



    4,334



    (331)







    4,714



    4,285



    Net cash used in operating activities



    (12,267)



    (10,624)



    INVESTING ACTIVITIES:











    Purchase of fixed assets



    (88)



    (242)



    Change in investment in current bank deposits





    3,200



    Transactions costs related to purchase of intangible assets





    (1,183)



    Proceeds from sale of financial assets at fair value through profit or loss



    475



    2,225



    Net cash provided by (used in) investing activities



    387



    4,000



    FINANCING ACTIVITIES:











    Proceeds from long-term borrowings, net of transaction costs





    79,345



    Proceeds from issuance of ordinary shares, net of issuance costs



    57,941





    Exercise of options into ordinary shares



    3,227





    Repayment of payable in respect of intangible asset purchase



    (2,125)





    Increase in restricted cash





    (20,000)



    Payment of principal with respect to lease liabilities



    (383)



    (261)



    Net cash provided by financing activities



    58,660



    59,084



    INCREASE IN CASH AND CASH EQUIVALENTS



    46,780



    52,460



    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS



    (103)



    131



    BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD



    29,295



    29,023



    BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD



    75,972



    81,614



    SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH



    19



    178



    SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH



    1,990



    231



    SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:











    Acquisition of right-of-use assets by means of lease liabilities





    1,575



    Long-term borrowings transaction costs





    1,284



     

     

    [i] Including cash, cash equivalents, short-term investments (bank deposits and financial assets at fair value) and restricted cash

    [ii] First quarter 2020 was the last quarter for Movantik as an Astra Zeneca product

    [iii] All financial highlights are approximate and are rounded to the nearest hundreds of thousands.

    [iv] Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.

    [v] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

    [vi] Aemcolo® (rifamycin) indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com

    [vii] Opaganib (ABC294640, Yeliva®) is an investigational new drug, not available for commercial distribution.

    [viii] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-reports-first-quarter-2021-financial-results-and-operational-highlights-301300719.html

    SOURCE RedHill Biopharma Ltd.

    View Full Article Hide Full Article
  25. TEL AVIV, Israel and RALEIGH, NC, May 26, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib[1] and RHB-107 (upamostat)[2] as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.

    RedHill Biopharma logo

    Both opaganib and RHB-107 are novel COVID-19 therapeutic candidates, in oral pill form, with dual mechanism of action effects. Both are host-targeted and are therefore expected to be effective against emerging viral variants with various mutations in the spike protein.

    "There is an urgent need for oral COVID-19 treatments for patients inside and outside of…

    TEL AVIV, Israel and RALEIGH, NC, May 26, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced receipt of two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) covering opaganib[1] and RHB-107 (upamostat)[2] as methods for the treatment of COVID-19 caused by the SARS-CoV-2 virus.

    RedHill Biopharma logo

    Both opaganib and RHB-107 are novel COVID-19 therapeutic candidates, in oral pill form, with dual mechanism of action effects. Both are host-targeted and are therefore expected to be effective against emerging viral variants with various mutations in the spike protein.

    "There is an urgent need for oral COVID-19 treatments for patients inside and outside of the hospital setting," said Danielle T. Abramson, Ph.D., VP, Intellectual Property & Research at RedHill. "With two novel oral COVID-19 therapeutics in late clinical-stage development, RedHill stands at the forefront of research for COVID-19 treatments. We are very pleased with the new intellectual property protection which extends until at least 2041. The Company has also filed for protection under the Patent Cooperation Treaty (PCT) and has the option of applying in the member countries thereof."

    Enrollment in opaganib's global Phase 2/3 study in hospitalized patients with severe COVID-19 (NCT04467840) is almost 100% complete. RHB-107's Phase 2/3 study is ongoing in non-hospitalized patients with symptomatic COVID-19 (NCT04723527) who do not require supplemental oxygen. Together, this covers potential treatment for the vast majority of affected patients.

    In view of the upcoming completion of enrollment, RedHill is evaluating the regulatory path for opaganib with a focus on those countries currently most affected by COVID-19. The regulatory path, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive as well as the specific requirements in each country. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has indicated we will need to complete additional studies to support applications in the U.S. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].

    Originally developed by Apogee Biotechnology Corp., opaganib's development has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases, with antiviral and potential tissue-protective effects. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment of non-hospitalized patients with symptomatic COVID-19 who do not require supplemental oxygen. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk of a delay in completion of enrollment for the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107, delay in top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib and the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required, and for RHB-107 may be required, by regulatory authorities to support such potential applications and the use or marketing of opaganib and/or RHB-107, as the case may be, for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

    [3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  26. TEL AVIV, Israel and RALEIGH, N.C., May 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at Digestive Disease Week (DDW) 2021 of two new analyses of Movantik® Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC).

    RedHill Biopharma Logo

    Both analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 546 patients in the placebo arms.

    "These two new analyses demonstrate…

    TEL AVIV, Israel and RALEIGH, N.C., May 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at Digestive Disease Week (DDW) 2021 of two new analyses of Movantik® Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC).

    RedHill Biopharma Logo

    Both analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 546 patients in the placebo arms.

    "These two new analyses demonstrate rapid and sustained efficacy of naloxegol for a broad range of bothersome OIC symptoms, positively impacting patient care. Given the challenge of OIC symptoms, early symptom relief is an important therapeutic consideration" said Prof. William D. Chey, Director of the GI Physiology Laboratory at the University of Michigan, and former Co-Editor-in-Chief of the American Journal of Gastroenterology.

    Poster 1 (Poster Number: Sa059): Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms: A Pooled Analysis of Two Global Randomized Placebo-Controlled Trials[1]

    Given the clinical importance of rapid and sustained OIC symptom response, this analysis aims to evaluate the efficacy of naloxegol (12.5 and 25 mg) on the key symptoms of OIC.

    Poster 2 (Poster Number: Sa058): Rapid Onset of Time to First Spontaneous Bowel Movement (SBM) and Predictable Efficacy of Naloxegol: Pooled Analysis of Two Global Randomized Controlled Trials[2] 

    Given the clinical importance of rapid and predictable symptom response, this analysis aims to characterize the predictability of the onset of response within 48 hours following the first dose of naloxegol (12.5 mg and 25 mg).  

    "OIC is the most common and debilitating gastrointestinal adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year[3]," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "Movantik has demonstrated its ability to help overcome one of the main challenges of opioid-based chronic pain management by bringing rapid and sustained relief from OIC."

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About Movantik® (naloxegol)

    Movantik® is an opioid antagonist indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Important Safety Information About Movantik

    Movantik® (naloxegol) is contraindicated in:

    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
    • Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.

    Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.

    Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

    Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Click here for the Medication Guide and full Prescribing Information for Movantik.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    MOVANTIK is a registered trademark of the AstraZeneca group of companies.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate and Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms: A Pooled Analysis of Two Global Randomized Placebo-Controlled Trials. Chey, William D.; Rockett, Carol B.; Bortey, Enoch; Almenoff, June.

    [2] Rapid Onset of Time to First Spontaneous Bowel Movement (SBM) and Predictable Efficacy of Naloxegol: Pooled Analysis of Two Global Randomized Controlled Trials. Chey, William D.; Rockett, Carol B.; Bortey, Enoch; Almenoff, June.

    [3] Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.      

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  27. TEL AVIV, Israel and RALEIGH, N.C., May 21, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation (poster number: Fr244) at Digestive Disease Week 2021 of a new Travelers' Diarrhea (TD) severity classification tool providing clear separation of clinical severity categories and prognostic information for TD resolution, with potential utility in clinical practice. The new tool was developed with the Center for Infectious Diseases, University of Texas Houston School of Public Health.

    RedHill_Biopharma_Logo

    The new classification tool was used to assess the efficacy of Aemcolo® (rifamycin) for the treatment of TD caused by non-invasive strains of E. coli in adults[1…

    TEL AVIV, Israel and RALEIGH, N.C., May 21, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation (poster number: Fr244) at Digestive Disease Week 2021 of a new Travelers' Diarrhea (TD) severity classification tool providing clear separation of clinical severity categories and prognostic information for TD resolution, with potential utility in clinical practice. The new tool was developed with the Center for Infectious Diseases, University of Texas Houston School of Public Health.

    RedHill_Biopharma_Logo

    The new classification tool was used to assess the efficacy of Aemcolo® (rifamycin) for the treatment of TD caused by non-invasive strains of E. coli in adults[1], reconfirming high levels of efficacy across both moderate and severe patient groups.

    "Antibiotics are the mainstay of treating bacterial TD; due to growing resistance, they should be reserved for use in more severe cases of the disease," said Professor Herbert L. DuPont, Director of the Center for Infectious Diseases, University of Texas Houston School of Public Health. "In order to help direct treatment to the most appropriate patients, we developed a new severity classification tool able to support accurate prognosis of disease course and resolution, based on extensive patient data from two Phase 3 trials in Travelers' Diarrhea, providing significant potential clinical utility. We then used the new classifications to assess the efficacy of rifamycin, reconfirming highly statistically significant efficacy across both newly reclassified moderate and severe patient groups."

    "Outcomes-focused clinical tools to assess the prognosis in TD have been lacking, and the development of this new Travelers' Diarrhea severity classification tool provides prognostic information that may help guide clinical practice," said June Almenoff, M.D., Ph.D., FACP, RedHill's Chief Medical Officer. "As the world returns to normal post-COVID pandemic, many Americans will likely want to resume travelling to countries where they are at high risk of infection with TD and will want to avoid the risk of ruining their trip by planning ahead for potential cases of TD."

    Aemcolo, containing 194 mg of rifamycin as delayed-release tablets, is an orally-administered, non-systemic antibiotic employing MMX® technology, a proprietary drug delivery system that distributes rifamycin in a controlled manner to the lower intestine. Due to its non-systemic delivery, Aemcolo is associated with limited side effects and minimal potential for interactions with other medications. 

    Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book[2]. The recommended dosage of Aemcolo is 388 mg (two tablets) orally, twice daily for three days.

    About Traveler's Diarrhea

    Travelers' Diarrhea (TD) is the most common travel-related illness, affecting an estimated 10% to 40% of travelers annually[iii]. Each year, approximately 70 million Americans travel abroad[iv]. Attack rates of TD range up to 70% of travelers, depending on the destination and season of travel[v]. TD may often result in short-term morbidity adversely impacting travel plans. Untreated diarrhea can also lead to an underappreciated risk of chronic complications, including functional bowel disorders[vi].

    About Aemcolo® (rifamycin)

    Aemcolo® (rifamycin) is an orally-administered, delayed-release, non-systemic antibiotic approved for the treatment of travelers' diarrhea caused by non-invasive strains of Escherichia coli (E. coli) in adults. Aemcolo® is the first antibiotic engineered with Cosmo Pharmaceuticals' Multi Matrix Technology (MMX®). MMX technology is designed to deliver the active pharmaceutical ingredients in a delayed and controlled manner directly to the lower intestine. 

    INDICATION AND IMPORTANT SAFETY INFORMATION

    Aemcolo® is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli) in adults.

    Limitations of Use

    Aemcolo® is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of E. coli.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aemcolo® and other antibacterial drugs, Aemcolo® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    CONTRAINDICATION

    Aemcolo® is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo®

    WARNINGS AND PRECAUTIONS

    Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool

    Aemcolo® was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea caused by pathogens other than E. coli and is not recommended for use in such patients.

    Discontinue Aemcolo® if diarrhea gets worse or persists more than 48 hours and consider alternative antibacterial therapy.

    Clostridium difficile-Associated Diarrhea (CDAD)

    CDAD has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    Consider CDAD in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

    Development of Drug-Resistant Bacteria

    Prescribing Aemcolo® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    ADVERSE REACTIONS

    Discontinuation of Aemcolo® due to adverse reactions occurred in 1% of patients. The most frequent adverse reactions were abdominal pain (0.5%) and pyrexia (0.3%).

    Adverse reactions that occurred in at least 2% of Aemcolo®-treated patients and with a higher incidence than in the placebo or ciprofloxacin groups were constipation 3.5% and headache 3.3%, respectively.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    There are no available data on AEMCOLO use in pregnant women to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    Lactation

    There is no information regarding the presence of AEMCOLO in human milk, the effects on the breastfed infant, or the effects on milk production.

    Pediatric Use

    The safety and effectiveness of AEMCOLO has not been established in pediatric patients <18 years of age.

    Click here for full Aemcolo® prescribing information

    To submit adverse event reports or product complaint reports, contact RedHill Biopharma, Inc. at 1(833)-ADR-HILL. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

    Aemcolo is a registered trademark of Cosmo Technologies Ltd. Aemcolo is manufactured by Cosmo S.p.A. for RedHill Biopharma Inc.

    About RedHill Biopharma Ltd.      

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[vii], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[viii], and Aemcolo® for the treatment of travelers' diarrhea in adults[ix]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate and Business

    Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    1 See full prescribing information: www.aemcolo.com

    2 https://wwwnc.cdc.gov/travel/yellowbook/2020/preparing-international-travelers/travelers-diarrhea

    iii FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-travelers-diarrhea

    iv Cosmo Pharmaceuticals Investor Presentation July 2019

    v CDC Yellow Book

    vi Steffen R, et al. JAMA. 2015;313(1):71-80.

    vii Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    viii Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.      

    ix Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-presents-a-new-travelers-diarrhea-clinical-severity-classification-tool-and-its-use-in-aemcolo-efficacy-analysis-at-ddw-2021-301296942.html

    SOURCE RedHill Biopharma Ltd.

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  28. TEL AVIV, Israel and RALEIGH, N.C., May 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2021 financial results and operational highlights on Thursday, May 27, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on Thursday, May 27, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2021.

    The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.  

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States

    TEL AVIV, Israel and RALEIGH, N.C., May 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its first quarter 2021 financial results and operational highlights on Thursday, May 27, 2021.

    RedHill Biopharma Logo

    The Company will host a webcast on Thursday, May 27, 2021, at 8:30 a.m. EDT, during which it will present key highlights for the first quarter of 2021.

    The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.  

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:

    +972-3-530-8845; the access code for the call is: 8506238.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-to-host-first-quarter-2021-financial-results-and-operational-highlights-webcast-on-may-27-2021-301295769.html

    SOURCE RedHill Biopharma Ltd.

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  29. TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to approximately 380 patients.

    RedHill Biopharma Logo

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With approximately…

    TEL AVIV, Israel and RALEIGH, N.C., April 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a fourth independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 255 patients treated for 14 days, extending the total opaganib safety database to approximately 380 patients.

    RedHill Biopharma Logo

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib." Dr. Levitt continued: "Moreover, adding together the positive Phase 2 data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase 2/3 study, which will provide the clearest indication to date of opaganib's promise in treating COVID-19."

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is over 75% enrolled in approximately 40 recruiting sites.

    RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.

    To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk of a delay in top-line data from the Phase 2/3 COVID-19 study, that such a study may not be successful, that opaganib will not be effective against emerging viral variants as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharmas-phase-23-covid-19-study-of-opaganib-passes-fourth-dsmb-review-with-unanimous-recommendation-to-continue-301265728.html

    SOURCE RedHill Biopharma Ltd.

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  30. TEL AVIV, Israel and RALEIGH, N.C., March 25, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

    RedHill Biopharma Logo

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe

    TEL AVIV, Israel and RALEIGH, N.C., March 25, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill Biopharma Inc., AztraZeneca AB and AstraZenca Pharmaceuticals LP ("AZ") and Nektar Therapeutics ("Nektar") have entered into a settlement and license agreement with MSN Pharmaceuticals, Inc. and MSN Laboratories PVT. LTD. ("MSN") resolving their patent litigation in the U.S. in response to MSN's Abbreviated New Drug Application ("ANDA") seeking approval by the US. Food and Drug Administration ("FDA") to market a generic version of Movantik® (naloxegol).

    RedHill Biopharma Logo

    RedHill acquired from AstraZeneca in April 2020 the global rights to Movantik, excluding Europe and Canada.

    Under the terms of the settlement agreement, MSN may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.

    The parties to the settlement agreement have also agreed to file a stipulation and order of dismissal with the U.S. District Court for the District of Delaware which will conclude this litigation with respect to MSN. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The settlement with MSN does not end RedHill's ongoing litigation against the other two ANDA filers.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

     

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

     



    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-announces-settlement-of-movantik-patent-litigation-with-msn-pharmaceuticals-301256045.html

    SOURCE RedHill Biopharma Ltd.

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  31. TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has acted on a request to provide opaganib[1] treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from COVID-19 pneumonia.

    RedHill Biopharma Logo

    Acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered opaganib within the past week. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be…

    TEL AVIV, Israel and RALEIGH, N.C., March 22, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has acted on a request to provide opaganib[1] treatment on an outpatient basis under compassionate use exemption for several Swiss patients suffering from COVID-19 pneumonia.

    RedHill Biopharma Logo

    Acting rapidly to ensure emergency transport and supply of drug, treatment was initiated with orally-administered opaganib within the past week. Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be effective against emerging viral variants with mutations in the spike protein.

    Gilead Raday, RedHill's Chief Operating Officer, said: "We continue to do all we can to support patients, and their treating physician, who are in need of treatment options for COVID-19. Having recently reported positive Phase 2 data with opaganib in the U.S., our ongoing global 464-patient Phase 2/3 study with opaganib for severe COVID-19 is now more than two thirds enrolled."

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is advancing in a total of eight countries and approximately 40 recruiting sites.

    RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo on top of standard-of-care treatment arms - further adding to the growing safety database for opaganib.

    To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a 40-patient U.S. Phase 2 study.

    Preclinical data have demonstrated anti-inflammatory, antiviral and anti-thrombotic activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome.

    Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that opaganib will not be effective against emerging viral variants as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    adi@redhillbio.com

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    bryan.gibbs@finnpartners.com

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  

    fennell@consilium-comms.com

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-announces-compassionate-use-treatment-with-opaganib-of-first-covid-19-patients-in-switzerland-301252751.html

    SOURCE RedHill Biopharma Ltd.

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  32. New York, March 18, 2021 (GLOBE NEWSWIRE) -- - Altiplano Metals closes C$3.1 million non-brokered private placement click here

    - Victory Square Technologies Inc (CSE:VST) (OTC:VSQTF) (FRA:6F6) says GameOn Entertainment Technologies has added veteran digital and media expert Liz Schimel to board click here

    - RedHill Biopharma Ltd (NASDAQ:RDHL) delivers revenue growth, commercial expansion and pipeline progress in FY2020 results as focused efforts pay off click here 

    - Goldcore Resources Ltd (CVE:GEM) (FRA:BK2P) to start trading as Green Battery Minerals on Monday, March 22 click here

    - ME2C Environmental  (OTCQB:MEEC) announces its participation in the creation of a new technologies firm, Eleclear Technologies click here 

    New York, March 18, 2021 (GLOBE NEWSWIRE) -- - Altiplano Metals closes C$3.1 million non-brokered private placement click here

    - Victory Square Technologies Inc (CSE:VST) (OTC:VSQTF) (FRA:6F6) says GameOn Entertainment Technologies has added veteran digital and media expert Liz Schimel to board click here

    - RedHill Biopharma Ltd (NASDAQ:RDHL) delivers revenue growth, commercial expansion and pipeline progress in FY2020 results as focused efforts pay off click here 

    - Goldcore Resources Ltd (CVE:GEM) (FRA:BK2P) to start trading as Green Battery Minerals on Monday, March 22 click here

    - ME2C Environmental  (OTCQB:MEEC) announces its participation in the creation of a new technologies firm, Eleclear Technologies click here 

    - Recruiter.com Group Inc (OTCQB:RCRT) boosts board with two new independent directors - an M&A and a human resources specialist click here 

    - Victory Resources  Corporation (CSE:VR) (OTC:VRCFF) (FRA:VR62) acquires the Smokey Lithium Project in Nevada click here 

    - Alpine 4 Holdings Inc (OTCQB:ALPP) taps former US Air Force Technical Sargent Nathan Grier for its Vayu unmanned aerial systems subsidiary click here 

    - Orgenesis Inc (NASDAQ:ORGS) collaborates with MIDA Biotech to establish point-of-care centers at hospitals and other medical institutions across western Europe click here 

    - Trillion Energy International Inc (CSE:TCF) (OTC:TCFF) (FRA:3P2N), the Turkey and Bulgaria-focused oiler, reveals latest year-end reserves report click here 

    -  American Resources Corporation (NASDAQ:AREC) says sponsored $100 million American Acquisition Opportunity SPAC begins trading on NASDAQ click here 

    - Blackrock Silver Corp (CVE:BRC) hits high-grade silver and gold at its Tonopah West project in Nevada click here 

    -  HempFusion Wellness Inc (TSE:CBD.U) (OTC:CBDHF) (FRA:8OO) to enter massive China market via subsidiary Probulin Probiotics on Alibaba Group Holding's Tmall Global click here 

     - Safe-T Group Ltd (NASDAQ:SFET) (TASE:SFET) subsidiary launches new IP Proxy platform click here 

     - NEXE Innovations Inc (CVE:NEXE) (OTC:NEXNF) (FRA:NX5) set to fully launch its XOMA Superfoods product line after a stellar pilot debut click here 

     - Marble Financial Inc (CSE:MRBL) (OTC:MRBLF) (FRA:2V0) launches its AI-driven financial wellness platform MyMarble with Canada Finances click here 

     - Silver Range Resources Ltd (CVE:SNG) (OTC:SLRRF) (FRA:8SR) updates on work progress at Stinson and Lucky Boy properties in Nevada click here 

     - First Mining Gold Corp (TSE:FF) (OTCQX:FFMGF) (FRA:FMG) says Auteco set to earn 51% of Pickle Crow gold project after fulfilling first stage requirements click here 

     - Aurania Resources Ltd (CVE:ARU) (FRA:20Q)  says undertaking overnight marketed public offering of units for gross proceeds of up to C$6.75M click here 

     - Vuzix Corp (NASDAQ:VUZI) (FRA:V7XN) M400 Smart Glasses deployed at New York distribution center click here 

     - Endeavour Mining Corp (TSE:EDV) (OTCQX:EDVMF) (FRA:E5Y1) reports record 4Q and FY2020 production from its West African gold operations click here 

     - PyroGenesis Canada Inc (TSX:PYR) (NASDAQ:PYR) (FRA:8PY) receives grant to develop pot lining waste recovery process click here 

     - NetCents Technology Inc (CSE:NC) (FRA:26N) (OTCQB:NTTCF) reports cryptocurrency transaction volume exceeds $10.8M in first half of March click here 

     - The Valens Company (TSE:VLNS) (OTCQX:VLNCF) (FRA:7LV) set to launch Verse Cannabis products on the Medical Cannabis by Shoppers platform click here 

     - XPhyto Therapeutics Corp (CSE:XPHY) (OTC:XPHYF) (FRA:4XT) announces EU approval for coronavirus test click here 

    - Heritage Cannabis Holdings Corp (CSE:CANN) (OTCQX:HERTF) says Health Canada has granted it the first-ever license to export cannabis products from Canada to Brazil click here 

    - Loop Insights Inc (CVE:MTRX) (OTCQB:RACMF) enters into five-store pilot with Canadian grocer Sobeys to deliver digital receipts via its Wallet Pass technology click here 

    - Delta 9 Cannabis Inc (TSX:DN) (OTCQX:DLTNF) announces grand opening of its eleventh cannabis retail store, and eighth in the Province of Manitoba click here 

    - Soma Gold Corp (CVE:SOMA) (OTC:PRSRF) (FRA:8PR1) encouraged by exploration drill results at its Colombia assets click here 

       

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  33. TEL AVIV, Israel and RALEIGH, N.C., March 18, 2021 /PRNewswire/ --

    Financials:

    Full year 2020 net revenues of approximately $64 million, with gross profit of approximately $27.5 million

    Solid cash balance of approximately $100 million as of March 4, 2021

    Planned commercial operational breakeven by the end of 2021

    Commercial Highlights:

    Talicia: Consistent month-over-month prescription growth despite pandemic conditions, with 52% new prescription growth in Q4/2020 compared to Q3/2020

    Movantik: Market leadership position holding strong and well-positioned for further growth in 2021

    R&D Highlights:

    Two advanced programs at the forefront of global COVID-19 novel therapeutics development:

      • Opaganib: Ongoing global Phase 2/3 study in hospitalized

    TEL AVIV, Israel and RALEIGH, N.C., March 18, 2021 /PRNewswire/ --

    Financials:

    Full year 2020 net revenues of approximately $64 million, with gross profit of approximately $27.5 million

    Solid cash balance of approximately $100 million as of March 4, 2021

    Planned commercial operational breakeven by the end of 2021

    Commercial Highlights:

    Talicia: Consistent month-over-month prescription growth despite pandemic conditions, with 52% new prescription growth in Q4/2020 compared to Q3/2020

    Movantik: Market leadership position holding strong and well-positioned for further growth in 2021

    R&D Highlights:

    Two advanced programs at the forefront of global COVID-19 novel therapeutics development:

      • Opaganib: Ongoing global Phase 2/3 study in hospitalized patients approximately two thirds enrolled, data expected Q2/2021; Positive U.S. Phase 2 data reported



      • RHB-107: Ongoing U.S. Phase 2/3 study in symptomatic non-hospitalized patients

    RHB-204: Ongoing Phase 3 study for pulmonary NTM disease as oral first-line treatment

    Management to host webcast today, at 8:30 a.m. EDT

    RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the year ended December 31, 2020.

    RedHill Biopharma Logo (PRNewsfoto/RedHill Biopharma)

    Dror Ben-Asher, RedHill's Chief Executive Officer, said: "2020 was a year that our team looks back on with a sense of immense achievement. While navigating the challenging conditions caused by the pandemic, we have delivered broad commercial growth culminating in a very strong end to 2020 for both Movantik and Talicia". Mr. Ben-Asher continued: "At the same time, we have rapidly progressed two novel oral COVID-19 therapies to Phase 3 stage development, covering both hospitalized and non-hospitalized patients and have reported positive clinical and preclinical data, positioning RedHill at the forefront of novel COVID-19 therapeutics development worldwide. With strong momentum across both commercial and R&D operations, we expect 2021 to be a breakout year."

    Micha Ben Chorin, Chief Financial Officer at RedHill, added: "RedHill is delivering on a clear strategy designed to enable us to achieve fast growth and increased profit margin. We have been diligent in maintaining a solid balance sheet and we expect to achieve commercial operational breakeven by the end of this year." 

    Financial highlights for the year ended December 31, 2020

    Net Revenues were approximately $64 million for the year ended December 31, 2020, an increase of $58 million compared to the year ended December 31, 2019, attributed to revenues generated from the commercialization of Movantik and Talicia initiated in 2020. Net revenues for the fourth quarter of 2020 were approximately $21.5 million, an increase of $0.5 million compared to the third quarter of 2020, with a 12% increase in product delivery.

    Gross Profit was approximately $27.5 million for the year ended December 31, 2020, an increase of $23.5 million compared to the year ended December 31, 2019, primarily due to the increase in net revenues.

    Research and Development Expenses were approximately $16.5 million for the year ended December 31, 2020, mainly attributable to the development of our COVID-19 therapeutics and the Phase 3 study of RHB-204 for pulmonary NTM disease, and were, in total, lower than the research and development expenses for the year ended December 31, 2019.

    Selling, Marketing and Business Development Expenses were approximately $49 million for the year ended December 31, 2020, compared to approximately $18 million for the year ended December 31, 2019. The increase was attributable to the expansion of our U.S. sales force and marketing activities, in support of the launch of Talicia and post-acquisition commercialization of Movantik.

    General and Administrative Expenses were approximately $25 million for the year ended December 31, 2020, compared to approximately $11 million for the year ended December 31, 2019. The increase was mainly attributable to the expansion of commercialization activities related to the Talicia launch and the Movantik acquisition from AstraZeneca.

    Operating Loss was approximately $64 million for the year ended December 31, 2020, compared to approximately $43 million for the year ended December 31, 2019. The increase was attributable to the expansion of our commercial operations.

    Net Loss was approximately $76 million for the year ended December 31, 2020, compared to approximately $42 million for the year ended December 31, 2019. The increase was attributable to factors mentioned above, as well as interest expenses mainly related to the royalty and debt financing in the first quarter of 2020. 

    Net Cash Used in Operating Activities was approximately $49 million for the year ended December 31, 2020, compared to approximately $41 million for the year ended December 31, 2019. The increase was attributable to the increase in operating loss, as described above.

    Net Cash Used in Investing Activities was approximately $36 million for the year ended December 31, 2020, primarily related to the $52.5 million upfront payment to AstraZeneca for the acquisition of Movantik, partially offset by inflow from current bank deposits and financial assets at fair value through profit or loss. 

    Net Cash Provided by Financing Activities was approximately $84 million for the year ended December 31, 2020, comprised primarily from financing inflow of approximately $102 million, mainly in debt and equity, partially offset by $16 million classified as restricted cash.

    Liquidity and Capital Resources

    Cash Balance[1] as of December 31, 2020, was approximately $46 million. Cash balance as of March 4, 2021 was approximately $100 million.

    Commercial Highlights

    Movantik® (naloxegol)[2]

    The Company has completed three full quarters of Movantik promotion following its acquisition from AstraZeneca, achieving: A reversal of the trend of declining new prescriptions prior to the acquisition, maintaining Movantik's position as a segment-leading brand and ending 2020 strongly recording the second highest monthly new prescription volume of 2020 in December.

    RedHill acquired the global rights to Movantik from AstraZeneca, excluding Europe and Canada, subsequently adding Israel rights, and replaced a co-commercialization agreement with Daiichi Sankyo (assigned under the agreement with AstraZeneca), with a new royalty-bearing agreement that resulted in RedHill assuming full control over brand strategy and commercialization activities for Movantik in the U.S. and increasing gross margin.

    Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[3]

    Despite the challenging pandemic environment, the Company has persisted in its efforts to support the launch and rapid growth of Talicia, in particular in expanding the prescriber base. This has resulted in the strong accumulation of new Talicia prescribers in the second half of 2020 and consistent month-over-month prescription growth despite pandemic conditions. Talicia ended 2020 strongly, with 52% new prescription growth in the fourth quarter of 2020, as compared to the previous quarter, and achieving its highest weekly new prescription volume in December.  

    This growth is supported by the addition of Talicia as a preferred brand on leading national formularies, approaching 70% U.S. commercial coverage in the fourth quarter, with further formulary additions expected to add to the previously announced listings of Talicia on the national formularies of Prime Therapeutics, EnvisionRx, and Express Scripts.

    Aemcolo® (rifamycin)[4]

    The Company has implemented plans to support, and build on, the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. The Company expects that these plans will drive a resurgence of interest in Aemcolo once travel restrictions are lifted and international travel from the U.S. returns to significant levels.

    R&D Highlights

    COVID-19 Program: Opaganib (ABC294640, Yeliva®)[5] 

    The late-stage development program for novel, orally-administered, opaganib in patients with severe COVID-19 pneumonia is progressing rapidly. Opaganib has demonstrated dual anti-inflammatory and antiviral activity, targeting a human cell component involved in viral replication and therefore expected to be effective against emerging viral strains with mutations in the spike protein.

    The global Phase 2/3 randomized, double-blind, parallel-arm, placebo-controlled study of opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen (NCT04467840), is rapidly advancing in a total of 8 countries and approximately 40 recruiting sites, with additional expansion ongoing. The study has passed three Data Safety Monitoring Board reviews, including a futility review, which is suggestive that the study is progressing as expected. The 464-patient study has already enrolled approximately two thirds of the patients and is expected to deliver top-line data in the second quarter of 2021.

    In December 2020, the Company reported positive top-line safety and efficacy data from the U.S. Phase 2 study with opaganib in patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14, on top of standard-of-care. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing opaganib safety database.

    In September 2020, RedHill announced that opaganib demonstrated potent inhibition of SARS-CoV-2, achieving complete blockage of viral replication, as measured after three days incubation, in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study. Furthermore, treatment of cells infected with SARS-CoV-2 with opaganib did not compromise cell membrane integrity, a measure of cell viability and drug safety, further demonstrating opaganib's promising potential for treating patients with COVID-19. On top of its anti-inflammatory mechanism, opaganib is also one of very few orally available broad-spectrum antivirals in advanced clinical evaluation for treating COVID-19.

    The Company also signed collaborations with several U.S., European and Canadian suppliers, including with Cosmo Pharmaceuticals NV (SIX: COPN) for large-scale ramp-up of opaganib manufacturing, further strengthening manufacturing capabilities and capacity for opaganib.

    The Company continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up.

    COVID-19 Program: RHB-107 (upamostat)[6]

    In February 2021, RedHill announced dosing of the first patient in the U.S. Phase 2/3 COVID-19 outpatient study with novel, orally-administered, RHB-107 (upamostat). The study with once-daily RHB-107 is evaluating treatment of patients with symptomatic COVID-19 who do not require hospitalization - the vast majority of COVID-19 patients. The study allows patients to remain in the comfort of their home yet be monitored at a level previously possible only in a hospital setting, enabling increased compliance and retention rates.

    RHB-107 is a novel, orally-administered, serine protease inhibitor targeting human cell factors involved in viral entry and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. In previously announced in vitro results, RHB-107 strongly inhibited SARS-CoV-2 viral replication.

    RHB-204[7] - Pulmonary Nontuberculous Mycobacteria (NTM) Disease      

    In November 2020, RedHill commenced its U.S. Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection.

    The FDA also granted Fast Track designation for RHB-204 in January 2021, providing early and frequent communications and a rolling review of any New Drug Application (NDA). Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

    In October 2020, the Company announced that RHB-204 had been granted FDA Orphan Drug Designation. This, along with the previously granted QIDP designation, extends U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.

    Opaganib - Cholangiocarcinoma and Prostate Cancer

    The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is ongoing for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.

    In light of preclinical findings demonstrating tumor regression following combination treatment with opaganib and RHB-107 (upamostat), RedHill plans to add an additional cohort to the ongoing Phase 2a study, evaluating opaganib in combination with RHB-107, subject to discussions with the FDA. Opaganib has been granted FDA Orphan Drug Designation for the treatment of cholangiocarcinoma.

    An additional Phase 2 study with opaganib in prostate cancer is ongoing at the Medical University of South Carolina (MUSC). The study is supported by a National Cancer Institute grant awarded to MUSC with additional support from RedHill.

    COVID-19 Impact Update

    RedHill's primary concern during the COVID-19 pandemic continues to be the safety and health of its employees, patients, colleagues, and the communities to which we belong.

    Operationally, the actions the Company took to mitigate the impact of the COVID-19 pandemic continue to serve us well, with minimal effect on our ongoing operational and supply chain activities. Promotional activity has now been largely re-instated, where safe to do so, and in adherence to social distancing and other public health guidelines. RedHill will continue to assess the potential impact of COVID-19 on its business and operations.

    Conference Call and Webcast Information:

    The Company will host a conference call and live webcast today, Thursday, March 18, 2021, at 8:30 a.m. EDT to present the fourth quarter and full year 2020 financial results and operational highlights.

    The webcast and slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.         

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:

    +972-3-530-8845; the access code for the call is: 1830718.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® for the treatment of travelers' diarrhea in adults. RedHill's key clinical late-stage deve