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.
Vivian Liu, NexMed's chief executive officer said, "There were lessons learned from the studies which warrant further development of this product. We decided that NexMed will proceed with potential new licensing discussions. We have already received inquiries from companies with a focus in dermatology who are interested in commencing discussions."
NexMed, Inc leverages its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products that address unmet medical needs.