PLX Protalix BioTherapeutics Inc. (DE)
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
Pegunigalsidase alfa (PRX-102) - BRIGHT
Fabry disease
|
Phase 3
Phase 3
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
Pegunigalsidase alfa (PRX-102)
Fabry disease
|
PDUFA priority review
PDUFA priority review
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
|
Pegunigalsidase alfa (PRX-102) - BALANCE
Fabry disease
|
Phase 3
Phase 3
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
OPRX-106
Ulcerative Colitis
|
Phase 2
Phase 2
|
Phase 2 data released March 13, 2018 - key endpoints met. Data presented at DDW Meeting - 67% of patients experienced a clinical response.
|
|
AIR DNase (PRX-110)
Cystic Fibrosis
|
Phase 2
Phase 2
|
Phase 2 interim data released January 3, 2017. Full data released April 12, 2017. Company noted data were positive but results showed efficacy down on January data.
|
|
Taliglucerase alfa
Gaucher disease
|
Approved
Approved
|
Approved May 1, 2012.
|
Latest News
-
View Full Article Hide Full Article
CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that it received, on September 3, 2020, notification from the NYSE American LLC (the "NYSE American") that the Company has regained compliance with all of the continued listing standards set forth in Part 10 of the NYSE American Company Guide (the "Company Guide"). Specifically, that the Company has resolved the continued listing deficiency with respect to Sections 1003(a)(i) – (iii) of the Company Guide.
The Company previously received a deficiency letter from the NYSE American dated August 26, 2019, stating that the Company was not in compliance with the continued listing standards as set forth in Section 1003(a)(i) – (iii) of the Company Guide. As a result of management's efforts to regain compliance, the NYSE American has informed the Company that it is back in compliance with all of the continued listing standards by meeting the requirements of the $50 million market capitalization exemption in Section 1003(a) of the Company Guide from the stockholders' equity requirement. At the opening of trading on September 4, 2020, the below compliance (".BC") indicator was no longer disseminated and the Company was removed from the list of NYSE American noncompliant issuers on the NYSE American's website.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Pegunigalsidase alfa, Protalix's main investigational new drug product, is a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease. The FDA has accepted a Biologics License Application (BLA), and granted Priority Review designation, for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The BLA was submitted via the FDA's Accelerated Approval pathway. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
In addition, Protalix's development pipeline consists of other proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "plan," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will have significant limitations on its use or be commercially successful; risk that the FDA will request additional data or other conditions of the Biologics License Application (BLA) filing for Accelerated Approval of PRX–102; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with any collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; our ability to identify suitable product candidates and to complete preclinical studies of such product candidates; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]
View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-regains-compliance-with-nyse-american-continued-listing-standards-301125357.htmlSOURCE Protalix BioTherapeutics, Inc.
-
View Full Article Hide Full Article
CARMIEL, Israel, Sept. 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that Dror Bashan, the Company's President and Chief Executive Officer will present in the H.C. Wainwright 22nd Annual Global Investment Virtual Conference on Tuesday, September 15, 2020 at 12:00 PM, Eastern Time. The conference will be held virtually on September 14-16, 2020.
A live webcast of the presentation will be available at www.protalix.com on the event calendar page, https://tinyurl.com/y5l9u4gr. A replay of the presentation will be archived and available for at least 15 days following the presentation.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]
View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-present-in-the-hc-wainwright-22nd-annual-global-investment-virtual-conference-301125354.htmlSOURCE Protalix BioTherapeutics, Inc.
-
View Full Article Hide Full Article
CARMIEL, Israel,, Aug. 24, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced completion of the treatment period of its Phase III BRIGHT clinical trial of pegunigalsidase alfa, or PRX–102, for the proposed treatment of Fabry disease. The Company is currently working with its service providers to complete the final monitoring visits necessary for final analysis of the data; however, many sites are still impacted by ongoing local and state restrictions and precautions due to the COVID-19 pandemic. The Company anticipates announcing top-line results in the fourth quarter of 2020 once this process is completed.
"Completion of the BRIGHT study marks another important key milestone in our pursuit of an alternative dose and regimen of pegunigalsidase alfa for the proposed treatment of Fabry disease," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "We eagerly anticipate announcement of top-line data, and are working towards the completion of the final monitoring visits as quickly as possible. Our challenge now is to continue the work to finalize these last details with the ongoing headwinds from COVID-19. I am very proud of our team's execution in completing the study and am confident in their ability to have the final data as expeditiously as possible."
Mr. Bashan continued, "The BRIGHT study is the second Phase III study of PRX–102 in Fabry patients that we have completed as part of our comprehensive PRX–102 development program. We announced positive results earlier this year from our Phase III BRIDGE clinical trial, and we anticipate results from an interim analysis of our Phase III BALANCE clinical trial in the first half of 2021. In addition, earlier this month, we announced the filing of the PRX–102 BLA by the U.S. Food and Drug Administration with a PDUFA target date of January 27, 2021."
"Completion of the treatment period of the BRIGHT study represents another important milestone in the effort to advance this development program, and we are grateful to all of the patients and clinicians who have been dedicated to moving this program forward in spite of the challenges of COVID-19," said Giacomo Chiesi, Head of Chiesi Global Rare Diseases. "Pending regulatory approval, Chiesi is taking all steps necessary to be able to make PRX-102 available to patients as rapidly as possible."
About the Phase III BRIGHT Study
The BRIGHT study is a phase III, open label, switch over study to assess the safety, efficacy and pharmacokinetics of pegunigalsidase alfa (PRX–102) 2 mg/kg administered by intravenous infusion every four weeks for 52 weeks in patients with Fabry disease currently treated with enzyme replacement therapy (ERT): agalsidase alfa or agalsidase beta.
About Fabry Disease
Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. People living with Fabry inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time, accumulating primarily in blood and in blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.
About Pegunigalsidase Alfa
Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.
About Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.
About Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "plan," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will may have significant limitations on its use or be commercially successful; risk that the FDA will request additional data or other conditions of the Biologics License Application (BLA) filing for Accelerated Approval of PRX–102; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with any collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; our ability to identify suitable product candidates and to complete preclinical studies of such product candidates; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]Media Contact
Brian Pinkston
LaVoieHealthScience
+1-857-588-3347
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-announces-completion-of-the-treatment-period-for-its-phase-iii-bright-clinical-trial-of-pegunigalsidase-alfa-prx-102-for-the-proposed-treatment-of-fabry-disease-301116942.htmlSOURCE Protalix BioTherapeutics, Inc.; Chiesi
-
View Full Article Hide Full Article
CARMIEL, Israel, Aug. 11, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, or the Company, together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, an international research-focused healthcare group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease. The BLA was submitted via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa is the Company's purposefully designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate. The FDA set an action date of January 27, 2021, under the Prescription Drug User Fee Act (PDUFA). The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.
Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. This designation shortens the FDA review period following the acceptance of the BLA to six months compared to 10 months under standard review. Pegunigalsidase alfa was granted Fast Track designation by the FDA in January 2018.
The BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX–102 in patients receiving 1 mg/kg every other week.
"The FDA's acceptance of the BLA and grant of priority review for PRX-102 are significant achievements for Protalix and Chiesi, and represent a crucial step forward as we look to establish a new treatment option to the Fabry patient community," said Dror Bashan, Protalix's President and Chief Executive Officer. "Based on the encouraging results for PRX-102 we have seen to date, we are eager to continue discussions with the FDA and to continue our other development efforts for PRX-102, as marketing approval of PRX-102 is our top priority."
"PRX-102 represents an important advance in research with the potential to deliver significant advantages to patients with Fabry disease," said Giacomo Chiesi, Head of Global Rare Diseases. "We are very encouraged by the strong interest in this therapy among both patients and clinicians and we look forward to the prospect of making it available to patients around the world who can benefit from treatment."
About Fabry Disease
Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal α–Galactosidase–A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the α–Galactosidase–A enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure – particularly of the kidneys, but also of the heart and the cerebrovascular system.
About Pegunigalsidase Alfa
Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed PRX–102 to potentially address the continued unmet clinical need in Fabry patients.
About Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit www.chiesiglobalrarediseases.com.
About Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people. Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "plan," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: that the FDA might not grant marketing approval for PRX–102 by the PDUFA date or at all and, if approved, whether PRX–102 will may have significant limitations on its use or be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: risks that the FDA will request additional data or other conditions of our submission of any application for Accelerated Approval of PRX–102; slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount of our future revenues and expenditures; the risk that despite the FDA's grant of Fast Track designation for PRX-102, we may not experience a faster development process, review or approval compared to applications considered for approval under conventional FDA procedures; risks related to the FDA's ability to withdraw the Fast Track designation at any time; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact:
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]Media Contact:
Brian Pinkston
LaVoieHealthScience
+1-857-588-3347
[email protected]
View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-and-chiesi-global-rare-diseases-announce-us-food-and-drug-administration-acceptance-of-biologics-license-application-bla-for-pegunigalsidase-alfa-for-the-proposed-treatment-of-fabry-disease-and-grants--301109844.htmlSOURCE Protalix BioTherapeutics, Inc.
-
View Full Article Hide Full Article
CARMIEL, Israel, Aug. 10, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2020, and provided a business update on recent corporate and clinical developments.
"This quarter, we delivered on two very important milestones for the company: announcing positive topline results in our BRIDGE phase III clinical trial of PRX–102 for the treatment of Fabry disease and subsequent BLA submission to the U.S. Food and Drug Administration (FDA). We were able to accomplish these goals even as we faced the challenging headwinds from the global COVID-19 pandemic, and I am very proud of our entire team for their commitment and dedication," said Dror Bashan, Protalix's President and Chief Executive Officer. "As we look towards an exciting second half of the year, we are continuing to build Protalix for the long term. We augmented our research and development team with highly qualified and seasoned veterans to support and enhance our pipeline, and we announced a new partnership to explore the development of PRX–110." Mr. Bashan concluded, "We are gratified to have a balance sheet supporting our strategic plans and look forward to continuing to execute as we move towards the anticipated commercial launch of PRX–102 for the treatment of Fabry disease."
Recent Business Highlights
- Submitted a Biologics License Application (BLA) to the FDA for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease on May 27, 2020. The BLA was submitted under the FDA's accelerated approval pathway in collaboration with the Company's development and commercialization partner, Chiesi Farmaceutici S.p.A. On July 28, 2020, the FDA informed Chiesi that the BLA had been filed for review and that the FDA was working on the 74-day letter. In addition, the FDA informed Chiesi that no "Refuse To File" will be issued for the PRX-102 BLA.
- Announced positive topline results from our BRIDGE Phase III clinical trial of PRX–102 for the treatment of Fabry disease. The study was an open-label, switch-over trial designed to evaluate the safety and efficacy of 1 mg/kg PRX–102 infused every two weeks, in Fabry patients. The trial met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX–102.
- Enhanced the executive management team with the appointment of Yael Hayon, Ph.D. as Vice President, Research and Development. Dr. Hayon brings over a decade of pharmaceutical research and development experience in both the scientific operations and administrative functions.
- Entered into a non-binding term sheet with SarcoMed USA, Inc. to explore the development and commercialization of PRX–110 (alidornase alfa) in the treatment of Pulmonary Sarcoidosis and related diseases. SarcoMed USA was formed in 2017 to investigate if a novel DNase 1 compound could influence the chronic pulmonary inflammation seen in Pulmonary Sarcoidosis patients.
Second Quarter 2020 Financial Highlights
The Company recorded revenues from selling goods of $3.6 million during the three months ended June 30, 2020, an increase of $0.2 million, or 6%, compared to revenues of $3.4 million for the same period of 2019.
Revenues from license and R&D services for the three months ended June 30, 2020, were $7.3 million, a decrease of $1.5 million, or 17%, compared to revenues of $8.8 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 as well as lower costs related to the Company's phase III BALANCE clinical trial of PRX-102 for the treatment of Fabry disease.
Cost of goods sold was $1.8 million for the three months ended June 30, 2020, a decrease of $0.9 million, or 32%, from cost of goods sold of $2.7 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.
Research and development expenses were $9.2 million for the three months ended June 30, 2020, a decrease of $4.1 million, or 31%, compared to $13.3 million of research and development expenses for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX–102 and reduced costs related to the Company's phase III BALANCE clinical trial as well as a decrease in costs related to manufacturing of the Company's drug in development as some of the manufactured drug product and related costs have been recorded as inventory.
Selling, general and administrative expenses were $2.2 million for the three months ended June 30, 2020, an increase of $0.1 million, or 6%, compared to $2.1 million for the same period of 2019.
Cash and cash equivalents at June 30, 2020 was $4.8 million, with $35.2 million in bank deposits.
Conference Call and Webcast Information
The Company will host a conference call on Monday, August 10, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate, and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:
Domestic:
877-423-9813
International:
201-689-8573
Conference ID:
13706783
Webcast:
The conference call will be broadcast live and also available for replay for two weeks on the Company's website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix was the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.
Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.
Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human α–Galactosidase–A protein for the proposed treatment of Fabry disease; OPRX–106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; PRX–115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "plan," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks that the FDA will not accept an application for accelerated approval of PRX–102 with the data generated to date or will request additional data or other conditions of our submission of any application for accelerated approval of PRX–102 and, if approved, whether PRX–102 will be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; and inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with Chiesi Farmaceutici and any other collaborator, distributor or partner; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of BioManguinhos alfataliglicerase generally; risks related to our commercialization efforts for BioManguinhos alfataliglicerase in Brazil; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; the risk that despite the FDA's grant of fast track designation for PRX–102, we may not experience a faster development process, review or approval compared to applications considered for approval under conventional FDA procedures; risks related to the FDA's ability to withdraw the fast track designation at any time; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; our ability to identify suitable product candidates and to complete preclinical studies of such product candidates; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.
Investor Contact
Chuck Padala, Managing Director
LifeSci Advisors
+1-646-627-8390
[email protected]Media Contact
Brian Pinkston
LaVoieHealthScience
+1-857-588-3347
[email protected]PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)
(Unaudited)
June 30, 2020
December 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents..............................................................................................
$
4,843
$
17,792
Short-term bank deposits…………………………………………………
30,147
-
Accounts receivable – Trade......................................................................................
5,262
4,700
Other assets................................................................................................................
2,893
1,832
Inventories.................................................................................................................
11,065
8,155
Total current assets..................................................................................................
$
54,210
$
32,479
NON-CURRENT ASSETS:
Long-term bank deposits.............................................................................................
$
5,025
-
Funds in respect of employee rights upon retirement..................................................
2,005
$
1,963
Property and equipment, net........................................................................................
4,793
5,273
Operating lease right of use assets..............................................................................
5,677
5,677
Total non-current assets...........................................................................................
$
17,500
$
12,913
Total assets...............................................................................................................
$
71,710
$
45,392
LIABILITIES NET OF CAPITAL DEFICIENCY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade.........................................................................................................................
$
6,707
$
6,495
Other.........................................................................................................................
11,910
11,905
Operating lease liabilities
1,145
1,139
Contracts liability.........................................................................................................
18,352
16,335
Promissory note...........................................................................................................
4,301
4,301
Total current liabilities...............................................................................................
$
42,415
$
40,175
LONG TERM LIABILITIES:
Convertible notes..........................................................................................................
$
52,622
$
50,957
Contracts liability..........................................................................................................
4,122
16,980
Liability for employee rights upon retirement................................................................
2,665
2,565
Operating lease liabilities...............................................................................................
4,526
4,528
Other long term liabilities..............................................................................................
124
509
Total long term liabilities...........................................................................................
$
64,059
$
75,539
Total liabilities...........................................................................................................
$
106,474
$
115,714
COMMITMENTS
CAPITAL DEFICIENCY..............................................................................................
(34,764)
(70,322)
Total liabilities net of capital deficiency.....................................................................
$
71,710
$
45,392
PROTALIX BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except per share data)
(Unaudited)
Six Months Ended
Three Months Ended
June 30, 2020
June 30, 2019
June 30, 2020
June 30, 2019
Revenues from selling goods
$
8,679
$
6,960
$
3,648
$
3,430
Revenues from license and R&D services
23,934
15,726
7,319
8,817
Total revenue
32,613
22,686
10,967
12,247
Cost of goods sold
(5,253)
(4,740)
(1,827)
(2,695)
Research and development expenses, net (1)
(19,526)
(25,021)
(9,186)
(13,323)
Selling, general and administrative expenses (2)
(5,381)
(4,298)
(2,194)
(2,068)
Operating income (loss)
2,453
(11,373)
(2,240)
(5,839)
Financial expenses
(5,177)
(3,827)
(1,948)
(1,907)
Financial income
241
193
38
3
Financial expenses, net
(4,936)
(3,634)
(1,910)
(1,904)
Net loss for the period
$
(2,483)
$
(15,007)
$
(4,150)
$
(7,743)
Loss per share of common stock - basic and diluted
$
(0.12)
$
(1.01)
$
(0.13)
$
(0.52)
Weighted average number of shares of common
stock used in computing loss per share –
basic and diluted
19,923,935
14,838,213
32,442,636
14,838,213
(1) Includes share-based compensation
$
73
$
316
$
(5)
$
138
(2) Includes share-based compensation
$
625
$
87
$
272
$
(25)
View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-second-quarter-2020-financial-results-and-provides-business-update-301108969.htmlSOURCE Protalix BioTherapeutics, Inc.
- Submitted a Biologics License Application (BLA) to the FDA for PRX–102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease on May 27, 2020. The BLA was submitted under the FDA's accelerated approval pathway in collaboration with the Company's development and commercialization partner, Chiesi Farmaceutici S.p.A. On July 28, 2020, the FDA informed Chiesi that the BLA had been filed for review and that the FDA was working on the 74-day letter. In addition, the FDA informed Chiesi that no "Refuse To File" will be issued for the PRX-102 BLA.