USA — GlaxoSmithKline (GSK) has announced that it will pay US$90 million upfront to acquire antifungal drug Brexafemme from New Jersey-based biotech company Scynexis.
The drug, which is already approved in the U.S. for treating vulvovaginal candidiasis (VVC), represents a valuable addition to GSK’s portfolio.
The deal also includes the right for GSK to access Scynexis’ other preclinical assets derived from enfumafungin, thereby expanding the company’s antifungal therapy pipeline.
Under the terms of the agreement, additional payments of up to US$503 million may be made to Scynexis if Brexafemme achieves certain milestones.
However, the deal does not cover Greater China, where the drug is already owned by Chinese pharmaceutical company Hansoh Pharma.
The acquisition of Brexafemme is significant for GSK, as it comes at a time when antimicrobial therapies have long been an area of low investment interest in the biopharmaceutical industry.
Nonetheless, fungal infections are on the rise worldwide, prompting action by regulatory agencies and the World Health Organization, among others, to address the issue.
These infections include hospital-acquired infections (HAIs) which can be serious and even fatal.
GSK’s move to acquire Brexafemme is timely, given that just days ago, the US Centers for Disease Control and Prevention (CDC) warned about the spread of a potentially deadly drug-resistant fungus, Candida auris (C. auris).
Although this emerging pathogen is harmless to healthy people, it can cause serious illness in individuals with weakened immune systems, such as those in intensive care units. The CDC has reported that cases of C. auris infections have nearly doubled from 2019 to 2021.
In light of the rising incidence of fungal infections and the urgent need for effective treatments, GSK’s acquisition of Brexafemme is a positive step.
It reflects the company’s commitment to improving healthcare outcomes and strengthening its antifungal therapy pipeline, which could have far-reaching implications for patient care globally.
Brexafemme’s market performance
Brexafemme, the antifungal drug recently acquired by GSK from Scynexis, has had a mixed market performance.
In its first year on the market, the drug struggled to generate significant sales, but its fortunes improved in 2022.
However, sales remained relatively modest, with Scynexis reporting revenues of just US$1.6 million for the third quarter of 2022.
Despite these modest sales figures, Brexafemme’s potential as a treatment for vulvovaginal candidiasis (VVC) remains significant.
According to the US Centers for Disease Control and Prevention, up to 75% of women experience at least one episode of VVC in their lifetimes, highlighting the pressing need for effective treatments.
Brexafemme is currently the only oral pill approved by the US Food and Drug Administration for the treatment of VVC.
The acquisition of Brexafemme also gives GSK the right to develop the medication for the potential treatment of invasive candidiasis, a life-threatening fungal infection.
This indication is currently in late-stage clinical trials, and GSK expects to launch the product in 2026.
GSK’s Chief Commercial Officer, Luke Miels, has stated that the company believes it can leverage its commercial clout to significantly boost Brexafemme’s sales.
Specifically, he has projected that the drug could reach more than US$500 million in annual sales, a significant increase from the US$3.6 million it generated in the first nine months of 2022.
GSK stands out among its peer Big Pharma companies, as it has been consistently pursuing therapies for infectious diseases, which is an area that most other companies have been retreating from in favor of more lucrative therapeutic areas like cancer, inflammatory diseases, and cardiovascular disease.
Despite the growing global threat of antimicrobial resistance, GSK remains committed to combating infectious diseases, with a portfolio that includes strong positions in HIV and shingles.
Nearly two-thirds of GSK’s revenues come from infectious disease therapies, a rare example in the industry.
GSK’s commitment to infectious diseases is not limited to antifungal treatments. The company has two other antibiotics currently in development, including gepotidacin, which is in late-stage trials for uncomplicated urinary tract infections.
The company’s ongoing investment in infectious disease treatments underscores its belief that it is an area of significant unmet medical need.
Last week, Cidara Therapeutics’ antifungal injection, Rezafungin, was approved by the FDA to treat invasive candidiasis and candidemia.
This was a significant development as it marked the first approval of an antifungal drug in over a decade.
However, GSK has been in the antifungal space for years and is already well-positioned to leverage its existing infrastructure and expertise to bring its antifungal drug, Brexafemme, to market.
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