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Vivus said Friday that the Food and Drug Administration approved its new erectile-dysfunction drug, Stendra. If ever there was a me-too drug, Stendra is it. The drug targets the same protein, PDE5, as Pfizer's Viagra, Eli LillyCialis, and Levitra from GlaxoSmithKline, Bayer, and Merck.If the market is large enough, it's reasonable to go after the same indication in a different way. Forest Labs' Bystolic, for instance, was the 19th beta blocker on the market.
Vivus faces two challenges. Obviously, it has to differentiate itself from the other PDE5 drugs. The drug works faster than the other drugs, in as little as 15 minutes, which on the surface, would seem to be a substantial benefit. But 15 minutes still isn't spontaneous; it still requires some planning. For men who don't want to have to worry about when they'll get lucky, there's a daily version of Cialis.Probably of bigger concern are the impending generic versions of the erectile-dysfunction drugs starting in 2016. That doesn't give Vivus much time to get a foothold before cheap generics will indirectly affect sales. However, throughout the panel discussions, it was clear enough that with at least a 5% weight loss there was a health benefit to weight loss, even though a 10% weight loss seemed more ideal. Overall the benefit analysis of the presentation put more pressure on the FDA to approve an obesity drug
You can buy Vivus in online pharmacy. Vivus is looking for a marketing partner to help sell the drug. Even with the challenges, Stendra is probably worth something to a large pharma. Marketing drugs to the masses is their thing. Vivus is a biopharmaceutical company. The Company is engaged in development and commercialization of therapeutic drugs for large underserved markets, including obesity and related morbidities, such as sleep apnea and diabetes and men�s sexual health.
The biotech also has an obesity drug, Qnexa, that's under review with the FDA. Two big-market drugs would make for a good acquisition, as opposed to a licensing deal, but with the Qnexa decision delayed, doubt any pharma is going to make that move before the FDA decision. A Vivus approval seems likely, but it isn't guaranteed. Unless Vivus wants to delay Stendra launch in hopes of finding a buyer if Qnexa is approved in July, it'll have to make a licensing deal now. Of course, being a me-too drug, maybe Vivus will follow in the same footsteps as ICOS.
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