(Adds GSK response in paragraph 8 and updates stock movement)
Written by Manas Mishra
Sept 25 (Reuters) – Synexis said on Monday it would voluntarily recall an antifungal drug it licenses to GSK due to the risk of cross-contamination with potential allergenic compounds, reducing its stake to 30%. It fell more than that.
The drug company said it became aware that the substances used to make the drug, including beta-lactams, were manufactured using a device called Brexafem, which is also used in that treatment.
U.S. Food and Drug Administration guidelines require companies to manufacture beta-lactam compounds separately from other drugs because they can cause hypersensitivity or allergic reactions in some people.
Synexis said the recall is prudent and it has not received any reports of adverse events due to potential cross-contamination of beta-lactams.
The company also put clinical studies on the drug on hold until mitigation strategies and resupply plans are determined.
Guggenheim analysts estimated it would take “at least several months” for the company to develop a mitigation strategy, resupply the market and restart clinical trials.
The yeast infection drug, first approved in 2021, brought in sales of $5 million in 2022. GSK, which licensed the drug from Synexis in March, had expected peak sales of the drug to be $500 million.
GSK “continues to evaluate the situation with Scynexis Inc. to determine next steps,” a company spokesperson said.
According to U.S. government data, up to 75% of women experience at least one vulvovaginal candidiasis, commonly known as vaginal yeast infection, in their lifetime.
Shares of New Jersey-based Synexis fell 34.5% to $2.17 in morning trading, giving up most of the gains since the GSK acquisition was announced. As of Friday’s closing price of $3.31, the company’s market capitalization was approximately $123 million.
The FDA did not immediately respond to a request for comment on the recall.
(Reporting by Manas Mishra in Bengaluru and Ludwig Berger in Frankfurt; Editing by Krishna Chandra Elli)
