Just as the Centers for Disease Control and Prevention (CDC) warns about the alarming spread of an emerging drug-resistant fungus, GSK has moved to snatch an FDA-approved drug that could tackle the pathogen—and salvage a floundering company along the way.
GSK is shelling out $90 million upfront to obtain the antifungal drug Brexafemme from New Jersey biotech Scynexis, the British pharma said Thursday. The drug is approved in the U.S. to treat a type of vaginal infection called vulvovaginal candidiasis (VVC).
Additional payments of up to $503 million are also up for grabs if Brexafemmet meets certain milestones. The deal excludes Greater China, where Chinese company Hansoh Pharma owns the drug. And besides Brexafemme, GSK also has right to call dibs on Scynexis’ other preclinical assets derived from enfumafungin.
Antimicrobial therapies have long been an area of low interest in the biopharma investment world. But GSK struck the deal just days after the U.S. CDC warned about the alarming spread of a potentially deadly drug-resistant fungus, a type of yeast called Candida auris, or C. auris.
The emerging pathogen is harmless to healthy people but can cause serious sickness in people with weakened immune systems, such as those admitted to the ICU. Reports of infections of C. auris nearly doubled from 2019 to 2021, according to a new CDC report released last week.
Brexafemme kills off yeast by inhibiting fungal cell wall synthesis. The oral drug has shown activity against C. auris, GSK said. The drug’s approved use, VVC, is a non-life-threatening disease that’s mostly caused by another WHO-designated priority fungal pathogen called Candida albicans.
GSK believes it can leverage its commercial clout to bring Brexafemme to more than $500 million in annual sales, chief commercial officer Luke Miels told reporters Thursday. That’s compared to just $3.6 million in sales the drug collected in the first nine months of 2022. The British pharma is interested in both VVC and a potential expansion in invasive candidiasis fungal infection, which the company expects to launch in 2026, he said.
The timeline was extended from the 2024 target that Scynexis laid out in October. The company is running the phase 3 FURI study for Brexafemme in fungal infections that are refractory or intolerant to standard antifungal treatment, including infections caused by C. auris. Together with data from two other phase 3 clinical trials, Scynexis previously said it expected to enter the hospital setting in 2024.
Last week, after a decade-long drought, the FDA just approved Cidara Therapeutics’ once-weekly antifungal injection Rezzayo to treat invasive candidiasis and candidemia.
GSK is a rare example of a Big Pharma company that derives a large part of its revenues from infectious diseases. Despite the rise of antimicrobial resistance, Big Pharma companies have been retreating from the field in favor of lucrative therapeutic areas such as cancer, inflammatory diseases and cardiovascular disease. Instead, special-purpose funds and small biotechs like Scynexis have become the main forces fighting the antimicrobial battle.
As a result of lackluster sales, Scynexis in October started a search for a U.S. commercialization partner and winded down its own promotional activities around Brexafemme. The company cut about 40% of its workforce and refocused its resources on developing the antifungal for severe, hospital-based indications, including invasive candidiasis.
To hear GSK’s Miels tell it, the demand for Brexafemme is there, and Scynexis, like many other biotechs, was just facing challenges in funding commercialization in the U.S.
“In our modeling and research, we could see that when customers were made aware of this, there was a high willingness to prescribe,” Miels said during the press call. “The challenge was [in] physicians who would be likely to see these types of patients, the awareness was relatively low.”
That’s where GSK wants to leverage its scale. The company has plenty of experience in navigating access and educating physicians to make the scientific case about a new drug, Miels said.
An outlier among its peers, GSK gets about two-thirds of its revenues from infectious diseases thanks to its strong positions in HIV and shingles. And during a recent interview, Miels told Fierce Pharma that GSK doesn’t plan to change that business structure and will continue to invest heavily in infectious diseases.
The Scynexis deal marks the third major act for GSK in the antimicrobial field in less than a year. In a similar deal where GSK played the white knight and saved a struggling biotech, the British pharma in September laid out $66 million upfront to in-license Spero Therapeutics’ oral antibiotic tebipenem, which was previously hit with an FDA rejection in complicated urinary tract infections.
And in November, GSK stopped two phase 3 trials of its antibiotic gepotidacin after the studies met their goals early. GSK plans to file the drug for uncomplicated urinary tract infection.
The three drugs share the same target physician groups, including primary care doctors, urologists and gynecologists, Miels said. GSK is now building a commercial infrastructure around the three meds, starting with gepotidacin’s expected launch next year.