Novadel Pharma Inc.(NVD) recently received FDA approval of its Zolpimist™ (zolpidem tartrate) 5 mg and 10 mg Oral Spray.
Zolpimist™ is intended for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpimist™ is now the second NovaDel product approved by the FDA that uses NovaDel’s proprietary NovaMist oral spray technology. Zolpimist™ contains the same active ingredient as Sanofi Aventis' Ambien®, the leading sedative hypnotic for the treatment of insomnia. Sanofi Anantis' patent for zolpidem tartrate expired on April 21, 2007, and the FDA subsequently approved the first generic versions of Ambien® (zolpidem tartrate) immediate-release tablets.
Mylan Pharmaceuticals (MYL), TEVA Pharmaceuticals USA (TEVA), Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy's Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical Company, Caraco Pharmaceutical Laboratories, Carlsbad Technology, and Lek Pharmaceuticals were the 13 companies approved by the FDA to manufacture generic immediate-release tablets.
So, the December 22, 2008 announcement that the FDA approved NovaDel's oral spray version now puts NovaDel in powerful company. And, Novadel's Zolpimist™ should be a big hit amongst insomnia drug consumers.
NovaDel is currently engaged in commercializing Zolpimist™, which will surely attract big pharma partners. Additionally, NovaDel is currently finalizing commercialization plans for NitroMist™ - which was their first FDA approval. NitroMist™ offers acute relief for heart and coronary artery disease (acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease).
Furthermore, NovaDel is also involved in looking to ultimately enterprise an oral-spray version of a generic form of Pfizer's Viagra® (active ingredient: sildenafil), something that Pfizer (PFE) itself has already been looking into doing. To this end, it therefore may make sense for Pfizer to hook-up with NovaDel. There had previously been rumors of the two teaming together, which both companies denied at the time, but, with NovaDel's star power now rising- and with Pfizer, now more than ever, looking to partner up with companies big and small- the Novadel dance could, indeed, be viable.
In the world of biopharma microcaps- a world in which there seems to be a small company on every street corner looking to strike it big and rich with just the right pharma product, NovaDel certainly stands out from the pack. That's not to say that there aren't a few others, but NovaDel is clearly onto something with their "oral-spray version of big name drug" niche.
And it will not be long before big pharma comes calling- especially now that the FDA has firmly accepted NovaDel into their brotherhood- which as every biopharma/biotech investor knows, is an incredibly impossible thing to do. And NovaDel did it.
Novadel has graduated to the major leagues. And this small company out of Flemington, NJ is poised for big things. In fact, given all the recent and emerging developments surrounding the strong NovaDel drug pipeline, I wouldn't be at all surprised if a major pharmaceutical comes along and simply buys out NovaDel Pharma lock, stock 'n "oral-spray" barrel.
(GT McDuffy does not hold any positions in NovaDel Pharma Inc.)
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