After submitting its antifungal drug rezafungin for FDA review, Cidara Therapeutics is handing off exclusive U.S. licensing rights to Melinta Therapeutics in exchange for $30 million upfront.
Upon FDA approval, Melinta will commercialize the drug, which is designed to treat candidemia and invasive candidiasis. In total, Cidara could make up to $460 million off the agreement, including $60 million in regulatory milestones and up to $370 million in commercial milestones, plus tiered royalties on yearly sales.
“This transaction eliminates the need for Cidara to build commercial infrastructure to launch rezafungin in the U.S.,” Jeffrey Stein, Ph.D., Cidara’s president and CEO, said in a July 27 release. The CEO noted that Melinta—a Connecticut biotech with five approved antibiotics and antibacterials including high blood pressure med Toprol-XL, which it acquired from AstraZeneca—has experience selling infectious disease products and has a commercial infrastructure already in place.
Cidara's share price rose 18% in the market's opening hours, from $0.68 at market close Tuesday to $0.81 by 11:30 a.m. ET today.
Cidara submitted rezafungin’s new drug application to the FDA on July 22, the company said. The once-weekly antifungal takes aim at invasive candidiasis and candidemia—common causes of bloodstream infections in hospitalized patients that can result in death, according to the CDC.
Rezafungin has received both an orphan tag and qualified infectious disease product designation from the FDA, classifications that will fast-track the agency’s review of the drug. If accepted for review, the FDA said Cidara would hear back regarding rezafungin in the first quarter of 2023.
The new drug submission was based on Cidara’s global phase 2 Strive and phase 3 Restore trials, in which the antifungal demonstrated statistical non-inferiority versus the current standard of care.
The licensing deal with Melinta will allow Cidara to turn its focus to its Cloudbreak platform based around drug-Fc conjugates designed to inhibit viral and oncology diseases while also engaging the immune system.
CEO Stein said the biotech is also actively seeking a partner for rezafungin in Japan.
In a separate ongoing phase 3 trial, Cidara is evaluating rezafungin for preventing invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation.