JERSEY CITY, N.J. & SHANGHAI–(BUSINESS WIRE)–Feb 17, 2021–
SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”, 3692:HK), one of the leading biopharmaceutical companies in China, today announced a strategic partnership and license agreement for the development and commercialization of Ibrexafungerp for the Greater China region.
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Ibrexafungerp is a first-in-class, broad-spectrum triterpenoid antifungal agent providing the therapeutic advantages of both intravenous and oral formulations. It is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of vaginal yeast infections, and in late-stage development for multiple indications, including life-threatening fungal infections in hospitalized patients.
“We are excited and honored to partner with Hansoh Pharma given their strong experience in the infectious disease space and their exceptional development, manufacturing and commercial capabilities in Greater China.” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “This agreement represents a major step forward for ibrexafungerp in the global market, as resistance to azoles grows and deadly fungal infections such as Candida auris continue to emerge worldwide. This partnership not only provides non-dilutive funding to our Company but also further validates the potential of ibrexafungerp as a global anti-fungal franchise. We continue to seek other opportunities to monetize our global rights and leverage ibrexafungerp’s long-lasting patent exclusivity.”
Aifeng Lyu, Ph.D., President of Hansoh Pharma, added, “Antifungal resistance is on the rise, posing a global health threat, and with only three classes of antifungal drugs on the market, we recognize the urgent need for more effective antifungal therapies. We believe in ibrexafungerp’s potential to address this need and we are confident that with our integrated R&D, manufacturing, and commercial infrastructure, we can make ibrexafungerp a significant commercial success in Greater China. We look forward to working with SCYNEXIS to bring this novel and differentiated antifungal to patients in Greater China.”
Under the terms of the agreement, Hansoh shall be responsible for the development, regulatory approval, and commercialization of ibrexafungerp in Greater China. SCYNEXIS will receive a $10 million upfront payment and will also be eligible to receive development and commercial milestones, plus low double-digit royalties on net product sales.
Ibrexafungerp is an oral antifungal product candidate under regulatory review for the treatment of vaginal yeast infection also known as vulvovaginal candidiasis (VVC). Its mechanism of action is fungicidal against Candida species, meaning it kills fungal cells. In December 2020, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application for ibrexafungerp and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. The NDA is supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated statistically superior efficacy and a favorable tolerability profile in women with VVC. If approved, this could be the first new antifungal class in over 20 years, and the first and only non-azole treatment for vaginal yeast infections.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. Our lead candidate ibrexafungerp (formerly known as SCY-078), a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, is under regulatory review for vaginal yeast infection and in late-stage development for multiple life-threatening fungal infections in hospitalized patients. The SCYNEXIS team has deep expertise in anti-infective drug development and marketing, which can be leveraged to advance ibrexafungerp from clinical development to commercialization. For more information, visit www.scynexis.com.
About Hansoh Pharmaceutical Group
Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States.
Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, and autoimmune diseases, among others. With the support of over 1,400 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including morinidazole (迈灵达®), a third-generation nitroimidazole antibiotic; PEG-loxenatide (孚来美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; flumatinib (昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); and almonertinib (阿美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations.
For more information, visit www.hspharm.com
SCYNEXIS Forward Looking Statement
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding SCYNEXIS’s expected timing of FDA approval and the commercial launch of ibrexafungerp and the potential benefits of ibrexafungerp. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks inherent in SCYNEXIS’s ability to successfully obtain regulatory approval to commence the commercial launch of ibrexafungerp; SCYNEXIS’s need for additional capital resources; and SCYNEXIS’s reliance on third parties to conduct SCYNEXIS’s commercialization efforts. These and other risks are described more fully in SCYNEXIS’s filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Form 10-Q under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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KEYWORD: NEW JERSEY CHINA UNITED STATES NORTH AMERICA ASIA PACIFIC
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SOURCE: Hansoh Pharma
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PUB: 02/17/2021 08:15 AM/DISC: 02/17/2021 08:15 AM
JERSEY CITY, N.J. & SHANGHAI–(BUSINESS WIRE)–Feb 17, 2021–