RDHL Redhill Biopharma Ltd.

6.44
-0.16  -2%
Previous Close 6.6
Open 6.53
52 Week Low 5.9
52 Week High 11.52
Market Cap $300,876,884
Shares 46,720,013
Float 46,720,013
Enterprise Value $319,915,088
Volume 223,248
Av. Daily Volume 300,658
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Upcoming Catalysts

Drug Stage Catalyst Date
YELIVA (Opaganib)
COVID-19
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
YELIVA (Opaganib)
COVID-19
Phase 2a
Phase 2a
Phase 2 initial data released December 31, 2020.
YELIVA (Opaganib)
Cholangiocarcinoma
Phase 2a
Phase 2a
Phase 2a enrolment of second arm has been initiated - March 11, 2020.
TALICIA (RHB-105)
H. pylori
Approved
Approved
FDA Approval announced November 4, 2019.
RHB-107 (upamostat)
COVID-19 (outpatients)
Phase 2/3
Phase 2/3
Phase 2/3 initiation of dosing announced February 17, 2021.
RHB-204
Nontuberculous mycobacteria (NTM) infections
Phase 3
Phase 3
Phase 3 trial initiation announced November 20, 2020.
RHB-104 MAP
Crohn’s disease
Phase 3
Phase 3
Phase 3 data released July 30, 2018. Primary endpoint met but further trial required.
BEKINDA
Gastroenteritis
Phase 3
Phase 3
Phase 3 additional trial planned.
BEKINDA
IBS-D
Phase 2
Phase 2
Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05. Follow up analysis identfied p value = 0.036. Phase 3 trial planned.

Latest News

  1. 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

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    [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 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
  2. 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

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236



    [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
  3. 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

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236

    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783

    [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 or visit www.rns.com.

    SOURCE: RedHill Biopharma Ltd.



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  4. 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



     

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783  


    [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.

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  5. 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

    Media contacts:
    U.S.: Bryan Gibbs, Finn Partners
    +1 212 529 2236

    UK: Amber Fennell, Consilium
    +44 (0) 7739 658 783

    [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 or visit www.rns.com .

    SOURCE: RedHill Biopharma Ltd.



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