A primary-in-class antifungal that did not turn out to be a giant vendor underneath Scynexis is getting one other probability with GSK, which has agreed to purchase rights to the drug for $90 million. It’s the second antimicrobial deal struck by the pharmaceutical big prior to now six months.
In keeping with deal phrases introduced Thursday, GSK is getting rights to the Scynexis drug, Brexafemme, which was accredited in 2021 for treating vulvovaginal candidiasis (VVC), or vaginal yeast an infection. These rights cowl commercialization and growth globally, apart from China. Milestone funds to Scynexis may high $500 million.
“We imagine that GSK will maximize Brexafemme’s industrial potential in VVC,” Scynexis CEO David Angulo mentioned, talking throughout a Thursday morning convention name. “This settlement additionally additional validates our imaginative and prescient for this first-in-class antifungal to turn out to be a important remedy choice in a number of different fungal infections. And GSK, with its world footprint, is an optimum companion on this endeavor in guaranteeing that this groundbreaking remedy reaches and advantages as many sufferers as doable around the globe.”
Brexafemme is the one FDA-approved product of Jersey Metropolis, New Jersey-based Scynexis. The small molecule is a triterpenoid, a kind of drug that works by inhibiting the synthesis of an enzyme necessary to the formation of a key a part of the fungal cell wall. The top result’s the dying of the fungus, a unique strategy than different medication that purpose to inhibit fungal progress. The Scynexis drug is at the moment the one FDA-approved antifungal for treating VVC and for decreasing the incidence of recurrent VVC.
Differentiation from different antifungals has but to translate into massive Brexafemme gross sales. Within the first 9 months of 2022, the corporate reported $3.5 million in product income. The drug was marketed underneath an settlement with Amplity Well being, a contract commercialization group.
Final October, Scynexis introduced it might terminate the Amplity deal as a part of a company strategic shift. Below the change, Scynexis would focus its assets on medical growth of its primary asset to be used in treating extreme, hospital-based indications that would generate larger income. The corporate additionally mentioned it deliberate to outlicense Brexafemme for vaginal yeast infections and search for one other U.S. commercialization companion. Enter GSK.
Within the announcement of the licensing deal, GSK mentioned Brexafemme enhances its antibiotic candidate gepotidacin, which is on monitor for regulatory submissions as a remedy for uncomplicated urinary tract infections. The GSK antibiotic pipeline additionally consists of tebipenem, an experimental remedy for classy urinary tract infections that was developed by Spero Therapeutics. Final September, GSK agreed to pay $66 million up entrance to accumulate world rights to that drug, excluding sure Asian markets. The Spero drug is at the moment in a Section 3 check being performed by Spero.
Scynexis’s drug presents GSK extra alternatives past vaginal yeast an infection. A Section 3 check is at the moment evaluating the drug as a remedy for invasive candidiasis, which is a life-threatening fungal an infection. That trial will proceed underneath Scynexis. But when the examine results in an FDA-approved product, the licensing settlement makes GSK accountable for as much as $245.5 million in milestone funds to Scynexis. One other $15 million milestone fee is due if the drug is accredited in an extra indication. Milestone funds associated to gross sales of the molecule may attain $242.5 million. GSK should additionally pay Scynexis royalties from gross sales throughout all accredited indications.
Brexafemme’s rights in Larger China are held by Hansoh underneath a 2021 settlement. Scynexis retains rights to different belongings derived from the antifungal compound that led to the event of Brexafemme. Nonetheless, the GSK take care of Scynexis offers the pharma big the best of first negotiation to those pre-clinical and discovery stage belongings.
Photograph by GSK
