NEXM ($.37) -- Volume Thursday 2.70M
"NexMed, Inc., incorporated in 1987, is a pharmaceutical and medical technology company with a focus on developing and commercializing therapeutic products based on its delivery systems. The Company focuses its efforts on new and topical pharmaceutical products based on a penetration enhancement drug delivery technology known as NexACT, which may enable an active drug to be better absorbed through the skin. The NexACT transdermal drug delivery technology is designed to enhance the absorption of an active drug through the skin, overcoming the skin’s natural barrier properties, and enabling high concentrations of the active drug to rapidly penetrate the desired site of the skin or extremity.
The Company has applied the NexACT technology to a variety of compatible drug compounds and delivery systems, and, on its own or through development partnerships, are in various stages of developing new topical treatments for male and female sexual dysfunction, nail fungus, psoriasis, and other dermatological conditions. The Company has a global licensing agreement with Novartis International Pharmaceutical Ltd. (Novartis), for NM100060, its topical nail solution for the treatment of onychomycosis (nail fungal infection). In July 2008, Novartis completed testing for the Phase 3 clinical trials for NM100060. The Phase 3 program required for the filing of the New Drug Application (NDA) in the United States for NM100060 consisted of two pivotal, randomized, double-blind, and placebo-controlled studies. The parallel studies were designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis. Approximately 1,000 patients completed testing in the two studies, which took place in the United States, Europe, Canada, and Iceland. On August 26, 2008, the Company announced that based on first interpretable results of these two Phase 3 studies, Novartis had decided not to submit the NDA at this time.
The Company has under development, a topical alprostadil-based cream treatment intended for patients with erectile dysfunction (Vitaros), which was previously known as Alprox-TD. The NDA filed and accepted for review by the United States Food and Drug Administration (FDA). On July 21, 2008, the Company received a not approvable action letter from FDA in response to its NDA.
The Company is developing Femprox, which is an alprostadil-based cream product intended for the treatment of female sexual arousal disorder. It has completed nine clinical studies to-date, including one 98-patient Phase II study in the United States for Femprox, and also a 400-patient study for Femprox in China. It has also continued early stage development work for its product pipeline focusing its attention on product opportunities that would replicate the model of its licensed anti-fungal nail treatment."
Why Buy?
1. Southland Capital Advisors has been the only insider to sell any of its shares in the past two years, and the sale occurred August 26, 2008. (http://www.reuters.com/finance/stocks/insiderTrading?symbol=NEXM.W&name=&pn=1&sortDir=DESC&sortBy=d)
2. In lieu of cash compensation, the Non-Employee Directors have opted to receive, and the Board of Directors has approved, a grant of shares of the Company's common stock for the Non-Employee Directors' services rendered to the Board of Directors during the third quarter of the 2009 calendar year. The price per share (the "Price") is the average of the closing price of the Company's common stock over five consecutive trading days, commencing on January 2, 2008. The number of shares was calculated based on the amount of cash the Director would have received for service on the Board, divided by the Price.
3. News on the phase III results will come soon.
