GSK amends commercial deal with Scynexis as antifungal recall drags into 2024

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来源: FiercePharma

Under the partners’ original deal in March, GSK was set to make additional payments to Scynexis of up to $503 million contingent upon Brexafemme reaching certain milestones.

When GSK laid out $90 million upfront to acquire rights to Scynexis’ antifungal Brexafemme last spring, the British pharma threw a lifeline to a company whose blockbuster launch ambitions had hit the skids. But now, as an October recall of the antifungal bleeds into 2024, the scope of GSK’s financial assistance has waned.

GSK and Scynexis have amended their license agreement in connection with the marketing delay on Brexafemme, Scynexis said in a recent securities filing. Under the retooled deal, Scynexis will keep hold of the $90 million it received from GSK in March, plus another $25 million in development milestones.

But the company’s future payouts from GSK—now in charge of development, manufacture and commercialization of Scynexis' medicine outside of China and certain other countries—have diminished.

The news sent Scynexis’ shares tumbling roughly 14.5% on Wednesday morning. It marks the latest downturn for a company whose flagship medication once bore blockbuster sales expectations.

On the regulatory front, Scynexis is now in line to receive approval-related milestone payments of up to $49 million, down from a total of $70 million that GSK had previously floated.

Potential commercial milestones in invasive candidiasis have also been downgraded from an original offer of up to $115 million to a new maximum payout of $57.5 million.

Meanwhile, Scynexis could now clinch up to $179.5 million in potential sales-based milestones, dependent upon the timing of Brexafemme’s re-launch in the U.S. Previously, the company had the potential to receive a $242.5 million payday in connection with Brexafemme’s commercialization.

Under the partners’ original deal in March, GSK was set to make payments of up to $503 million contingent upon Brexafemme reaching certain milestones. Aside from Brexafemme, GSK also got the rights to call dibs on certain other preclinical assets from Scynexis' pipeline.

GSK previously figured it could use its commercial clout to bring Brexafemme to more than $500 million in annual sales, chief commercial officer Luke Miels told reporters last year. The British pharma is interested in both Brexafemme’s original indication in the vaginal infection vulvovaginal candidiasis (VVC), plus a potential expansion into invasive candidiasis fungal infection, which Miels previously said the company expected to launch in 2026.

GSK’s March licensing deal came at a critical time for Jersey City, New Jersey-based Scynexis. In October of 2022, the company had laid out a contingency plan to “refocus its resources” on the clinical development of its antifungal in hospital-based indications, which the company expected to bring “higher long-term returns.”

But a manufacturing review by GSK last fall soured the partners' outlook in the near term after the discovery of cross-contamination risks forced a recall of the product and a pause of all clinical trials testing the medicine.

At the time, Reuters cited Guggenheim analysts who believed it would take “several months” for Scynexis to resolve the production snafu.

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