PLX Protalix BioTherapeutics Inc. (DE)

3.73
0  0%
Previous Close 3.73
Open 3.69
52 Week Low 1.7
52 Week High 4.865
Market Cap $121,011,032
Shares 32,442,636
Float 32,108,135
Enterprise Value $146,021,032
Volume 82,983
Av. Daily Volume 251,713
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Upcoming Catalysts

Drug Stage Catalyst Date
Pegunigalsidase alfa (PRX-102) - BRIGHT
Fabry disease
Phase 3
Phase 3
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Pegunigalsidase alfa (PRX-102) - BALANCE
Fabry disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pegunigalsidase alfa (PRX-102)
Fabry disease
BLA Filing
BLA Filing
BLA filing announced May 28, 2020.
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

  1. CARMIEL, Israel, June 8, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE:PLX) (TASE: PLX) today announced the appointment of Yael Hayon, Ph.D. as the Company's new Vice President, Research and Development, effective July 5, 2020. On June 2, 2020, Yoseph Shaaltiel, Ph.D. retired from his position as the Company's Executive Vice President, Research and Development, effective June 15, 2020.

    "Yossi's incredible scientific and entrepreneurial vision led to his founding of Protalix," said Zeev Bronfeld, Chairman of Protalix's Board of Directors. "Yossi's efforts resulted in the development of ProCellEx®, our proprietary plant cell-based protein expression system which we use to produce taliglucerase alfa, an approved treatment for Gaucher disease, pegunigalsidase alfa, our investigational treatment for Fabry disease which is in the latter stages of clinical development and our other investigational drug candidates. The Board of Directors and I are immensely grateful to Yossi for his knowledge, leadership, integrity and professionalism in building Protalix from its founding days to where it is today. We wish him all the best in his future endeavors."

    "I am delighted that Yael is joining the Protalix team where she will bring valuable and diverse research & development experience and knowledge," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are greatly thankful to Yossi for his exceptional efforts in founding and building Protalix, and wish him great success in the future."

    Dr. Hayon brings to the Company over a decade of experience in pharmaceutical research and development, both in the scientific operations and the administrative functions. She most recently served as Vice President of Clinical Affairs of Syqe Medical Ltd., Tel-Aviv, where she, among other things, established the clinical and medical global strategy, and was responsible for providing strategic input on the regulatory development plan. Prior to her role at Syqe Medical, Dr. Hayon served as the Head of R&D Israeli Site of LogicBio Therapeutics, Inc., Cambridge, Massachusetts, where she managed LogicBio's Israeli-based Research and Development facility and was involved in strategic decision-making. From 2014 through 2016 she served as the R&D Manager, Stem Cell Medicine Ltd., Jerusalem, Israel. Dr. Hayon holds a Ph.D. in Neurobiology/Hematology, and an MS.c. in Neurobiology, both from the Hebrew University Faculty of Medicine, Jerusalem, Israel.

    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 in the currently anticipated timeline or at all and, if approved, whether PRX–102 will be commercially successful; failure or delay in the commencement or completion of our preclinical and clinical trials; risks associated with the novel coronavirus disease (COVID–19) outbreak, which may adversely impact our business, preclinical studies and clinical trials; 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; 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

    Media Contact

    Brian Pinkston

    LaVoieHealthScience

    +1-857-588-3347

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-appoints-yael-hayon-phd-as-its-new-vice-president-research-and-development-301072291.html

    SOURCE Protalix BioTherapeutics, Inc.

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  2. CARMIEL, Israel, June 1, 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 first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments. The Company's management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

    Protalix_Biotherapeutics_Logo

    "The first quarter of 2020 has most certainly been transformational…

    CARMIEL, Israel, June 1, 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 first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments. The Company's management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

    Protalix_Biotherapeutics_Logo

    "The first quarter of 2020 has most certainly been transformational for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix's President and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running smoothly and adapt quickly to the changing environment."

    "During the quarter, we were able to close a $43.7 million private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study and the subsequent BLA submission for PRX–102 announced in May prove that Protalix has actually gained momentum by leaning into this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward to continuing our momentum through the rest of this year and into 2021."

    Conference Call and Webcast Information

    The Company will host a conference call on Monday, June 1, 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:  

    13704328

    Webcast: 

    https://tinyurl.com/yc32s9jn 

    The conference call will also be broadcast live and 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.

    First Quarter 2020 and Recent Business Highlights

    Clinical and Regulatory Advancements

    • On May 28, 2020, the Company and its development and collaboration partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., or Chiesi, announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa, or PRX–102, for the treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. PRX–102 was granted Fast Track designation by the FDA in January 2018. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.
    • On May 11, 2020, the Company announced positive topline results following the completion of its Phase III BRIDGE clinical trial of PRX–102 for the treatment of Fabry disease. The Phase III BRIDGE clinical trial, a 12-month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, 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.
    • On February 6, 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.

    Corporate & Financial Developments

    • On March 16, 2020, the Company announced that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. The Company received a non-refundable payment of $1.0 million and Kirin will provide research funding for the Company's scientists to conduct cell line engineering and protein expression studies on the target protein.
    • On March 12, 2020, the Company entered into securities purchase agreements with certain existing and new institutional and other accredited investors in a private placement. Pursuant to such agreements, the Company issued and sold to the purchasers an aggregate of approximately 17.6 million unregistered shares of its common stock at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of the Company's common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.

    Financial Results

    For the three months ended March 31, 2020, compared to the three months ended March 31, 2019

    • The Company recorded revenues from selling goods of $5.0 million during the three months ended March 31, 2020, an increase of $1.5 million, or 43%, compared to revenues of $3.5 million for the same period of 2019. The increase resulted primarily from an increase of $0.8 million in sales of drug product to Brazil as well as an increase of $0.7 million in sales of drug substance to Pfizer Inc.
    • Revenues from license and R&D services for the three months ended March 31, 2020, were $16.6 million, an increase of $9.7 million, or 140%, compared to revenues of $6.9 million for the same period of 2019. Revenues from the license agreements represent the revenues recognized in connection with previously announced agreements with Chiesi. The increase is primarily due to revenues recognized in connection with the progress of the Company's clinical trial that have been performed, and with revenues recognized in connection with an updated costs estimation throughout the trials until completion in the amount of $6.7 million.
    • Cost of goods sold was $3.4 million for the three months ended March 31, 2020, an increase of $1.4 million, or 68%, from cost of goods sold of $2.0 million for the same period of 2019. The increase is primarily due to an increase in sales of goods.
    • Research and development expenses were $10.3 million for the three months ended March 31, 2020, a decrease of $1.4 million, or 12%, compared to $11.7 million of research and development expenses for the same period of 2019. The decrease was primarily due to a decrease in costs related to manufacturing of our drug in development.
    • Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2020, an increase of $1.0 million, or 43%, compared to $2.2 million for the same period of 2019. The increase resulted primarily from a $0.6 million increase in compensation related costs and a $0.2 million increase in professional fees.
    • Net income for the three months ended March 31, 2020 was $1.7 million, or $0.10 per share, basic and diluted, compared to a net loss of $7.3 million, or $0.50 per share, basic and diluted, for the same period of 2019.

    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: 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 ultimate purchase by Fundação Oswaldo Cruz of BioManguinhos alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated amounts, if at all; 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.

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (U.S. dollars in thousands)

    (Unaudited)













    March 31, 2020




    December 31, 2019


    ASSETS


















    CURRENT ASSETS: 









      Cash and cash equivalents..............................................................................................


    $

    14,166



    $

    17,792


    Short-term bank deposits………………………………………………….



    22,509




    -


      Accounts receivable – Trade......................................................................................



    8,876




    4,700


      Other assets................................................................................................................



    2,728




    1,832


      Inventories.................................................................................................................



    9,488




    8,155


    Total current assets..................................................................................................


    $

    57,767



    $

    32,479











    NON-CURRENT ASSETS: 


















         Long-term bank deposits.............................................................................................


    $

    12,505




    -


         Funds in respect of employee rights upon retirement..................................................



    1,879



    $

    1,963


         Property and equipment, net........................................................................................



    5,012




    5,273


         Operating lease right of use assets..............................................................................



    5,713




    5,677


            Total non-current assets...........................................................................................


    $

    25,109



    $

    12,913


    Total assets...................................................................................................................


    $

    82,876



    $

    45,392











    LIABILITIES NET OF CAPITAL DEFICIENCY


















    CURRENT LIABILITIES: 









      Accounts payable and accruals: 









    Trade.........................................................................................................................


    $

    9,430



    $

    6,495


    Other.........................................................................................................................



    13,757




    11,905


          Operating lease liabilities



    1,126




    1,139


          Contracts liability.........................................................................................................



    19,014




    16,335


          Promissory Note..........................................................................................................



    4,301




    4,301


    Total current liabilities...............................................................................................


    $

    47,628



    $

    40,175











    LONG TERM LIABILITIES:









     Convertible notes..........................................................................................................


    $

    51,777



    $

    50,957


     Contracts liability..........................................................................................................



    7,130




    16,980


     Liability for employee rights upon retirement................................................................



    2,531




    2,565


     Operating lease liabilities...............................................................................................



    4,481




    4,528


     Other long term liabilities..............................................................................................



    210




    509


    Total long term liabilities...........................................................................................


    $

    66,129



    $

    75,539


    Total liabilities...........................................................................................................


    $

    113,757



    $

    115,714











    COMMITMENTS


















    CAPITAL DEFICIENCY..............................................................................................



    (30,881)




    (70,322)


    Total liabilities net of capital deficiency.....................................................................


    $

    82,876



    $

    45,392


     

     

    PROTALIX BIOTHERAPEUTICS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (U.S. dollars in thousands, except per share data)

    (Unaudited)







    Three Months Ended




    March 31, 2020



    March 31, 2019


    REVENUES FROM SELLING GOODS


    $

    5,031



    $

    3,530


    REVENUES FROM LICENSE AND R&D SERVICES



    16,615




    6,909


    TOTAL REVENUE



    21,646




    10,439


    COST OF GOODS SOLD



    (3,426)




    (2,045)


    RESEARCH AND DEVELOPMENT EXPENSES, NET (1)



    (10,340)




    (11,698)


    SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)



    (3,187)




    (2,230)


    OPERATING INCOME (LOSS)



    4,693




    (5,534)


    FINANCIAL EXPENSES



    (3,229)




    (1,920)


    FINANCIAL INCOME



    203




    190


    FINANCIAL EXPENSES, NET



    (3,026)




    (1,730)


    NET INCOME (LOSS) FOR THE PERIOD


    $

    1,667



    $

    (7,264)


    EARNINGS (LOSS) PER SHARE OF COMMON STOCK – BASIC AND









    DILUTED


    $

    0.10




    (0.50 )


    WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK









      USED IN COMPUTING EARNINGS (LOSS) PER SHARE-









      BASIC AND DILUTED



    17,381,074




    14,838,213


    (1) Includes share-based compensation


    $

    78



    $

    178


    (2) Includes share-based compensation


    $

    353



    $

    112


     

     

    Investor Contact
    Chuck Padala, Managing Director
    LifeSci Advisors
    +1-646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

    Cision View original content:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-first-quarter-2020-financial-results-and-business-update-301068400.html

    SOURCE Protalix Biotherapeutics Inc.

    View Full Article Hide Full Article
  3. CARMIEL, Israel, May 28, 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 the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway…

    CARMIEL, Israel, May 28, 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 the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa, or PRX-102, was granted Fast Track designation by the FDA in January 2018. Pegunigalsidase alfa is the Company's purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate.

    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. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.

    "We are grateful for the assistance the FDA provided leading up to the submission of this BLA via the Accelerated Approval pathway, and we look forward, together with Chiesi, to working with the FDA as we seek marketing approval for PRX‑102," said Dror Bashan, Protalix's President and Chief Executive Officer. "Together with Chiesi, we thank the investigators and study participants who have made reaching this milestone possible and have supported Protalix in our commitment to bringing this new treatment option to the Fabry patient community."

    "The submission of this BLA to the FDA represents a significant milestone for our Global Rare Diseases division that was established earlier this year to strengthen Chiesi's focus on making a difference for patients living with rare diseases around the world," said Giacomo Chiesi, head of Chiesi Global Rare Diseases. "Our partnership and active collaboration with Protalix are a great example showing how we can leverage Chiesi's global reach and decades of experience in drug development to support patients and their families living with Fabry disease and many other devastating rare diseases."

    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.

    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 in the currently anticipated timeline or at all 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: 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; 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
    646-627-8390

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    857-588-3347

     

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  4. CARMIEL, Israel, May 22, 2020 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 will release its financial results for the first quarter 2020 and business update on Monday, June 1, 2020. The Company's management will host a conference call to discuss the financial results and provide a general business update at 8:30 a.m. Eastern Daylight Time (EDT).

    Conference Call Details:
    Monday, June 1, 2020, 8:30 a.m. Eastern Daylight Time (EDT)
    Domestic: 877-423-9813
    International: 201-689-8573
    Conference ID: 13704328

    Webcast Details:
    Webcast Link: https://tinyurl.com/yc32s9jn
    Conference ID: 13704328

    The conference call will also be broadcast live and 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; 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

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    +1-857-588-3347

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-hold-first-quarter-2020-financial-results-and-business-update-conference-call-on-june-1-2020-301064204.html

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  5. CARMIEL, Israel, May 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, today announced positive topline results from its Phase III BRIDGE clinical trial of pegunigalsidase alfa, or PRX-102. Pegunigalsidase alfa is the Company's plant cell-expressed recombinant, PEGylated, cross-linked α-galactosidase-A product candidate under development for the treatment of Fabry disease.

    The BRIDGE study was a Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (Shire Plc) as Replagal®, for at least two years and on a stable dose for at least six months.

    Topline results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102. Consistent with previously announced interim data, PRX-102 was found to be well tolerated, with all adverse events being transient in nature without sequelae. Twenty-two patients were enrolled in the study; two of those patients withdrew early from the study due to hypersensitivity reaction, and 20 of the patients successfully completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension study and continue to be treated with PRX-102.

    In the study, the mean annualized eGFR slope of the study participants improved from ‑5.90 mL/min/1.73m2/year while on agalsidase alfa to -1.19 mL/min/1.73m2/year on PRX-102 in all patients. Male patients improved from -6.36 mL/min/1.73m2/year to ‑1.73 mL/min/1.73m2/year and female patients improved from ‑5.03 mL/min/1.73m2/year to ‑0.21 mL/min/1.73m2/year.

    Baseline characteristics of the patients, ranging from ages 24 to 60 years, were as follows: mean eGFR 75.87 mL/min/1.73m2 in males and 86.14 mL/min/1.73m2 in females and plasma lyso-Gb3 mean levels were 51.81 nM and 13.81 nM in males and females, respectively. While lyso-Gb3 levels remain slightly high, particularly within the male cohort, continuous reduction in lyso-Gb3 levels was observed of 19.55nM (32.35%) in males and 4.57nM (29.81%) in females.

    "The final analysis of the BRIDGE Study in Fabry patients previously treated with agalsidase alfa demonstrate a positive potential benefit of pegunigalsidase alfa on renal function," said Dr. Ales Linhart of Charles University in Prague, Czech Republic, a principal investigator in the BRIDGE study.

    "The completion of our Phase III BRIDGE study and its subsequent analysis mark a significant milestone towards our goal to establish PRX-102 as a new treatment option for Fabry disease," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are encouraged that the BRIDGE study successfully met its main objectives for safety and efficacy, and we are further motivated to continue our work in progressing pegunigalsidase alfa."

    "Our BRIDGE study, together with our other two ongoing fully enrolled Phase III clinical trials, the BALANCE study and the BRIGHT study, represents what we believe to be the most comprehensive and robust Phase III clinical program for Fabry disease currently in progress," continued Mr. Bashan. "As the first of our three studies to complete Phase III, we believe the BRIDGE study findings support that PRX-102 has the potential to be an important enzyme replacement therapy for the treatment of Fabry disease."

    The ongoing BALANCE study is a fully enrolled, randomized, double blind, head-to-head, active control study which aims to demonstrate PRX‑102's superiority in renal function as measured by the comparison of the mean annualized change (slope) in estimated glomerular filtration rate (eGFRCKD-EPI) between treatment groups over 24 months of treatment as compared to agalsidase beta, marketed by Sanofi Genzyme as Fabrazyme®. The BRIGHT study is a fully enrolled open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of PRX‑102, 2 mg/kg dosed once every 4 weeks, and to assess whether patients maintain clinical stability as measured by certain Fabry disease parameters after being switched to this regimen from an enzyme replacement therapy (ERT), agalsidase alfa or agalsidase beta, dosed every two weeks.

    "We previously announced positive interim results from 16 Fabry patients after six and twelve months in the BRIDGE study. These final results not only indicate that our findings are durable and consistent with previous analyses, but also demonstrate the important potential benefit of pegunigalsidase alfa on renal function for Fabry patients," said Einat Brill Almon, Ph.D., Protalix's Senior Vice President, Product Development. "We look forward to the continued findings from our other ongoing Phase III studies of PRX‑102, with the final results from the BRIGHT study expected in the fourth quarter of 2020, and interim results from the BALANCE study expected in the first half of 2021."

    As previously announced, the Company and its collaboration partner for PRX‑102, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via the FDA's Accelerated Approval pathway in the second quarter of 2020. The Company and Chiesi have experienced minor delays in completing the submission due to the novel coronavirus disease (COVID-19) outbreak and other reasons, and the Company anticipates providing further updates regarding the planned submission by the end of the current month.

    Additional Details about the BRIDGE Study

    Patients in the BRIDGE study were screened and evaluated over three months while continuing agalsidase alfa treatment. Following the screening period, each patient was enrolled and switched from agalsidase alfa treatment to receive intravenous infusions of PRX-102, 1 mg/kg every two weeks, for 12 months. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation.

    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 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, potentially clinically superior 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: 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 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; 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 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; 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
    646-627-8390  

    Media Contact
    Brian Pinkston
    LaVoieHealthScience
    857-588-3347

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