Barrier Therapeutics, Inc., a pharmaceutical company developing and commercializing products in the field of dermatology, will retain worldwide rights for all licensed indications to its oral antifungal product candidate, Hyphanox.
Janssen Pharmaceutica Products, L.P. held an option for the rights to Hyphanox on a geographic region by region basis, which had been negotiated as part of Barrier's initial license to the product rights. Barrier triggered the option based on the results of the recently completed Phase 3 non-inferiority clinical trial in vaginal candidiasis, in which Hyphanox demonstrated clinical efficacy that was not inferior to fluconazole, but did not reach the primary regulatory endpoint of therapeutic cure, said a company release here.
"We are very pleased with Janssen's decision and appreciate their efforts to provide us with a timely response," stated Geert Cauwenbergh, CEO of Barrier Therapeutics. "This action enables us to fully control the continued clinical development and potential partnering strategies for this very important asset," he added.
Hyphanox is a unique 200 mg tablet formulation of itraconazole, an antifungal agent that is used in the treatment of various fungal infections, including vaginal candidiasis, commonly known as vaginal yeast infection, and onychomycosis, commonly known as nail fungus. Itraconazole is approved for the treatment of both onychomycosis and vaginal candidiasis outside the United States, and for onychomycosis in the United States.