NexMed, Novartis agree to terminate anti-fungal product licensing pact

NexMed, Inc, a developer of products based on the NexACT technology, announced the mutual decision with Novartis to terminate the licensing agreement for NM100060, a topically-applied treatment for onychomycosis, commonly known as nail fungus. NexMed entered into the exclusive, worldwide agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.

In addition, NexMed also announced that the results from the comparator study of NM100060 vs. Loceryl, a topical nail lacquer currently marketed in Europe, showed comparable safety and efficacy profiles for the two products in patients with mild to moderate toenail fungus. In the post hoc analysis of patients with mild fungus, NM100060 showed higher efficacy, which was consistent with the results from the two Phase 3 pivotal studies completed by Novartis in 2008. However, the study results were insufficient to support filing for marketing approval.