Novartis opts out of approval application for antifungal drug


EAST WINDSOR, N.J. Novartis will not apply at this time for Food and Drug Administration approval of a nail fungus drug it developed with NexMed, according to a NexMed statement made Tuesday.

Following NexMed’s announcement of the decision, which was based on first interpretable results of phase III trials, NexMed shares declined by 96 cents to 40 cents a share. The shares were trading at 24 cents on the NASDAQ at midday Thursday.

The drug, NM100060, is a topical version of the antifungal drug terbinafine combined with NexMed’s NexACT drug-delivery technology. Novartis sells terbinafine as an over-the-counter topical ointment and prescription oral medication under the brand name Lamasil. Many companies also sell generic versions of the drug.

“While this is disappointing, a European comparator study is still ongoing, and those results are expected mid 2009,” NexMed President and chief executive officer Vivian Liu said.

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