NexMed Shares Plunge On Abstaining From Submitting NDA For Nail Fungus Drug

(RTTNews) - Shares of pharmaceutical company NexMed Inc. (NEXM | Quote | Chart | News | PowerRating) have tumbled Wednesday morning after the company decided to not file a New Drug Application with the FDA for its onychomycosis drug.

The stock plummeted about 81%, plunging $1.11 to 25 cents a share by 11:10 am Eastern Time. Shares of the East Windsor, New Jersey-based company broke through support and hit a new low.

After the closing bell on Tuesday, NexMed revealed its decision not to file a New Drug Application with the FDA for the company's onychomycosis drug NM100060. The decision was taken on the basis of the first interpretable results of the phase III clinical studies on NM100060, which is a topical application of terbinafine formulated with NexACT.

NexMed noted that two of the NM100060 studies were designed to evaluate its efficacy, safety and tolerability in patients with mild to moderate toenail onychomycosis or nail fungus. Results from these randomized, double blind and placebo-controlled studies did not indicate any significant adverse event.

All the clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060 were assumed by Novartis AG (NVS | Quote | Chart | News | PowerRating) in 2005, under an exclusive, worldwide agreement with NexMed.

NexMed Chief Executive Officer Vivian Liu said, "While this is disappointing, European comparator study is still ongoing, and those results are expected mid 2009."

Earlier in August, NexMed announced that previously unpublished clinical data on Femprox, the company's topical treatment for female sexual arousal disorder, was published in the August 2008 issue of The Journal of Sexual Medicine.

The article, entitled "Efficacy and Safety of Alprostadil Cream for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Placebo-Controlled Study in Chinese Population," describes the results of NexMed's 400 patient take-home study completed in China in 2005.

In late July, NexMed said that the U.S. Food and Drug Administration, or FDA, rejected its New Drug Application for the experimental topical treatment for erectile dysfunction.

The company said the major regulatory issue raised by the FDA was related to a study performed on mice to test whether an experimental product is carcinogenic or not. The company completed the study in 2002.

Commenting on the FDA's response, Liu said, "While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency."

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