FDA decision for NexMed expected (Nasdaq:NEXM)

NexMed, Inc. (Nasdaq:NEXM) is a specialty contract research organization – also called clinical research organization (CRO). It has decades’ experience of providing “in vitro and in vivo pharmacology services and research models”. Recently, it acquired Bio-Quant Inc. – a move that made it the largest CRO in the San Diego region. It is also a specialty pharmaceutical company that has a number of products under its pipeline. All these products have been developed using the company’s NexACT® drug delivery technology. Among its most popular products are an alprostadil treatment (which is currently in its second phase and is intended for sexual arousal disorders in females), another alprostadil treatment (intended for erectile dysfunction) and several other treatments for psoriasis and onychomycosis. For several months now, it is has been waiting for a response from the Food and Drug Administration (FDA). It is on the subject of the company’s carcinogenicity (CAC) assessment package. On January 8, 2010, the company disclosed that the FDA is likely to let the company know about its decisions within “the next two months”. As a result, all the stakeholders are expecting the FDA’s decision by no later than March 8, 2010.

Why are NexMed and its stakeholders eagerly waiting for the FDA decision? The answer was provided by the company itself. The decision is crucial because, without it, the company cannot proceed with its efforts to find a partner for its product Femprox®. This product aims to correct sexual dysfunction in females. And without a partner, NexMed cannot bring Femprox® into the market.

There are several well reputed global pharmaceutical companies who want to partner with NexMed for commercializing Femprox®. All of them will have to wait – at least until March 8.

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