SCYNEXIS has entered into a licensing agreement and strategic partnership with Hansoh Pharmaceutical Group. Under the terms of the agreement, Hansoh will obtain an exclusive license from SCYNEXIS to research, develop and commercialize ibrexafungerp in the Greater China region.
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 antifungal franchise. We continue to seek other opportunities to monetize our global rights and leverage ibrexafungerp’s long-lasting patent exclusivity.”
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“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,” Aifeng Lyu, Ph.D., President of Hansoh Pharma, said.
Under the terms of the agreement, Hansoh will 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 up to $112 million in development and commercial milestones, plus low double-digit royalties on net product sales.
Ibrexafungerp is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently under regulatory review for the treatment of vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), and in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.
The FDA has accepted a New Drug Application for ibrexafungerp for the treatment of VVC and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021. It also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.