2023-03-31| Licensing

GSK Bets $593 Million To License Scynexis’ Oral Antifungal

by Joy Lin
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Drug giant GlaxoSmithKline (GSK) is licensing Scynexis’ Brexafemme (ibrexafungerp tablets) in a deal valued at nearly $600 million. 

Brexafemme is the first oral antifungal to be approved by the US FDA for the treatment of vulvovaginal candidiasis (VVC) and for the reduction in the incidence of recurrent VVC (RVVC). VVC is a common yeast infection of the vagina, affecting up to 75% of women at least once, while 40-45% may experience two or more episodes. 

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Brexafemme Adds To GSK’s Antibiotic Portfolio

The exclusive license gives GSK the right to market Brexafemme for its two approved indications while also developing the antifungal, which is undergoing Phase 3 trials in invasive candidiasis (IC), a life-threatening fungal infection. The license covers all countries with the exception of the greater China region and countries where Brexafemme is already out-licensed. 

Under the terms of the agreement, Scynexis will receive $90 million upfront and up to $503 million in milestone payments. $245.5 million will be paid upon achieving development, regulatory, and commercial milestones related to the IC indication. The company could earn an extra $15 million if the FDA approves an additional indication. Commercial sales of Brexafemme could net Scynexis milestones payments of up to $242.5 million, along with tiered royalties in the mid-single digits to mid-teens. 

According to GSK, Brexafemme will complement the company’s portfolio, which includes gepotidacin, a late-stage antibiotic for uncomplicated urinary tract infection (uUTI), and tebipenem, gepotidacin’s counterpart for complicated cases of UTI (cUTI). 

“The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections. Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi. In addition, the transaction consolidates GSK’s synergistic portfolio of innovative late-stage antibiotics,” said Luke Miels, Chief Commercial Officer, GSK. 

Invasive candidiasis is an infection caused by a yeast called Candida. It can affect the tissues such as the blood, heart, brain, and other parts around the body. Multidrug-resistant types of Candida, such as Candida auris, is an emerging threat to the global healthcare system. According to the Centers for Disease Control and Prevention (CDC), C. auris infections in the US nearly doubled in 2021, from 756 to 1,471 cases. Nationwide, there were 2,377 clinical cases in 2022. The majority of cases were found to be resistant to antifungal treatments such as azoles, polyenes, and echinocandins. 

Brexafemme, a glucan synthase inhibitor, could provide an additional line of offense against antimicrobial resistance with its distinct mechanism of action, which is similar to echinocandins. The agent has shown activity against C. auris and C. albicans, two WHO-designated priority fungal pathogens

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