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NexMed, Inc. (NEXM) Shares Plunge on Decision not to Submit New Drug Application for NM100060

NexMed, Inc. (NASDAQ: NEXM), an innovative drug developer that is leveraging its proprietary drug delivery technology to develop a significant pipeline of innovative pharmaceutical products to address a host of medical needs, recently announced the company’s decision not to submit a New Drug Application (NDA) for NM100060. Shares of NexMed, Inc. declined more than 80 percent earlier this week on the news.

NM100060 is a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis (nail fungus). Based on First Interpretable Results of Phase III clinical studies for NM100060, the company has decided to not submit a NDA with the FDA at this time. NexMed’s president and chief executive officer, Vivian Liu, commented in a conference call earlier this week and stated, “We do not have all of the data right now, but we know that NM100060 is safe with no adverse events.”

NexMed entered into an exclusive, worldwide agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060. Novartis is currently in the early stages of reviewing the data and may take two to three months to generate the final report. Ms. Liu concluded, “I am very surprised by this setback. It is a major detour in our growth plan, but we are still moving forward with Novartis toward the ultimate goal of getting our product commercialized.

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