Pharmas Market with Mike Huckman

On Gaining More Impotence & Weightloss Drugs

I can’t wait until this drug rises to the level where it gets on Joe Kernen’sradar screen because, boy, is he gonna have a good time (not just with the drug perhaps, but mostly with talking on TV about it.) A little TMI, I know, but that’s Joe.

Sean Russell | Getty Images

Warner Chilcott is doing a late-stage study of an erectile dysfunction drug with a Korean pharma company called, “Dong-A.” I know the partnership isn’t news, but Miller Tabak healthcare analyst Les Funtleyder wasn’t sure I knew about it and knew that I could probably do something (i.e. blog) with it. And, of course, he was right. An ED drug made by a company whose name is Dong? Hello! Can’t believe I missed that one.

The pill, Zydena, is already on the market in Korea and in more than 30 other foreign markets, but the companies have to do a big test of it in the U.S. if they want to win FDA approval of it here. It’s similar to Pfizer’s Viagra, Lilly’s Cialis and Levitra from Merck, GlaxoSmithKline and Bayer. Vivus is also in the final stage of developing an ED drug in the same category. So, in the not-too-distant future we could be seeing commercials and ads for no fewer than five impotence treatments. ED is a multi-billion dollar and highly profitable drug market.

For VVUS, though, the main focus of investors isn’t on the ED drug, which supposedly gets in and out of the body faster than the competition, but on its weightloss pill. It’s one of three small biopharma companies in the final stage of developing the first prescription diet drugs since fen-phen fell. Yesterday, Arena Pharmaceuticals became the first of the trio to file for FDA approval. In the new year, VVUS and the third company, Orexigen, shouldn’t be too far behind. Then the balls will be in the FDA’s court. Abbott’s weightloss drug Medidia recently got a preliminary warning about a potential heart side effect. The FDA shot down Sanofi-Aventis’ Zimulti, which some analysts thought was going to be a mega-blockbuster, over psychiatric issues. So, there won’t be any slam dunks here.

The FDA will have its hands full. ARNA says if you printed out its application for approval it would wipe out a forest. We’re talkin’ three million pages, according to a spokesperson. The application includes data from 18 clinical trials involving more than 8,500 patients. The file was so big the company says it couldn’t send it to the agency electronically. Someone flew in to hand deliver the submission, but had to wait a day because the snowstorm closed the FDA. I guess they couldn’t trust it to FedEx or the postal service.

While there’s a lot of debate over which of the diet drugs is best and could grab the biggest market share if or when they get approved, another big factor for investors is corporate partnerships. All three companies are looking to buddy-up, but none has announced a deal yet.

I tried to cleverly tie this all together (Dong, ED, weightloss, etc.) here at the end, but couldn’t get anything to work. Wait, maybe that just did.

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