A first-in-class antifungal that failed to become a big seller under Scynexis is getting another chance with GSK, which has agreed to acquire rights to the drug for $90 million. It’s the second antimicrobial deal struck by the pharmaceutical giant in the past six months.
According to deal terms announced Thursday, GSK is getting rights to the Scynexis drug, Brexafemme, which was approved in 2021 for treating vulvovaginal candidiasis (VVC), or vaginal yeast infection. Those rights cover commercialization and development globally, except for China. Milestone payments to Scynexis could top $500 million.
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“We believe that GSK will maximize Brexafemme’s commercial potential in VVC,” Scynexis CEO David Angulo said, speaking during a Thursday morning conference call. “This agreement also further validates our vision for this first-in-class antifungal to become a critical treatment option in multiple other fungal infections. And GSK, with its global footprint, is an optimal partner in this endeavor in ensuring that this groundbreaking treatment reaches and benefits as many patients as possible around the world.”
Brexafemme is the only FDA-approved product of Jersey City, New Jersey-based Scynexis. The small molecule is a triterpenoid, a type of drug that works by inhibiting the synthesis of an enzyme important to the formation of a key part of the fungal cell wall. The end result is the death of the fungus, a different approach than other drugs that aim to inhibit fungal growth. The Scynexis drug is currently the only FDA-approved antifungal for treating VVC and for reducing the incidence of recurrent VVC.
Differentiation from other antifungals has yet to translate into big Brexafemme sales. In the first nine months of 2022, the company reported $3.5 million in product revenue. The drug was marketed under an agreement with Amplity Health, a contract commercialization organization.
Last October, Scynexis announced it would terminate the Amplity deal as part of a corporate strategic shift. Under the change, Scynexis would focus its resources on clinical development of its main asset for use in treating severe, hospital-based indications that could generate higher revenue. The company also said it planned to outlicense Brexafemme for vaginal yeast infections and look for another U.S. commercialization partner. Enter GSK.
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In the announcement of the licensing deal, GSK said Brexafemme complements its antibiotic candidate gepotidacin, which is on track for regulatory submissions as a treatment for uncomplicated urinary tract infections. The GSK antibiotic pipeline also includes tebipenem, an experimental treatment for complicated urinary tract infections that was developed by Spero Therapeutics. Last September, GSK agreed to pay $66 million up front to acquire global rights to that drug, excluding certain Asian markets. The Spero drug is currently in a Phase 3 test being conducted by Spero.
Scynexis’s drug offers GSK additional opportunities beyond vaginal yeast infection. A Phase 3 test is currently evaluating the drug as a treatment for invasive candidiasis, which is a life-threatening fungal infection. That trial will continue under Scynexis. But if the study leads to an FDA-approved product, the licensing agreement makes GSK responsible for up to $245.5 million in milestone payments to Scynexis. Another $15 million milestone payment is due if the drug is approved in an additional indication. Milestone payments related to sales of the molecule could reach $242.5 million. GSK must also pay Scynexis royalties from sales across all approved indications.
Brexafemme’s rights in Greater China are held by Hansoh under a 2021 agreement. Scynexis retains rights to other assets derived from the antifungal compound that led to the development of Brexafemme. However, the GSK deal with Scynexis gives the pharma giant the right of first negotiation to these pre-clinical and discovery stage assets.
Photo by GSK
