Knobias Clip Report (08-27-2008) NEXM
Submitted By Knobias ClipReport
NEXM: Shares Plunge on Decision Not To Submit NDA for NM100060
By Fain Hughes, fhughes@knobias.com
Shares of NexMed, Inc. (NEXM) plunged 82% on Wednesday after the Company reported that based on First Interpretable Results of Phase III clinical studies for NM100060, a topical application of terbinafine formulated with NexACT(R) for the treatment of onychomycosis (nail fungus), the decision has been taken not to submit a New Drug Application with the FDA at this time.
NexMed entered into an exclusive, worldwide agreement with Novartis (NVS) in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.
Vivian Liu, NexMed’s President and CEO, commented in a conference call today, “We do not have all of the data right now, but we know that NM100060 was safe with no adverse events. Novartis is in the early stages of reviewing the data and may take two to three months to generate the final report. For competitive reasons, Novartis has asked us not to release any information regarding the specific results. They will publish those results at a later time according to industry standards. In the meantime, Novartis is continuing with a comparator study in Europe which will be completed in early 2009, with results in mid-2009.”
She added, “This news is disappointing to us, however, it is important to note that the agreement with Novartis is still in place. So long as this agreement is in place, and we believe that it will remain so, we are entitled to receive the anticipated $3.5 million when our pending U.S. patent claim is allowed. We expect this to take place soon. In addition, we have been told by Novartis that should the results from the study in Europe be deemed sufficient to file in Europe, they may pursue European approval first. We would then be entitled to those milestones. The European Patent office has allowed the claim on our application. This does not trigger a milestone, but it does insure us full royalty payments for sales in those countries with patent coverage.”
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. I remain confident in NexMed and the opportunities ahead of us.”
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August 29th, 2008 at 10:45 am
I think this stock will rebound soon, it is a bargain to buy this stock at this price level.