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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Evan Dimmer who wrote (4275)	1/4/1998 12:53:00 PM
From: LoLoLoLita	Respond to of 23519

Evan, >>Do Viagra (Pfizer) and Vasomax (Zonagen) have to get the same kind >>of approval from the individual countries too? If so, have either >>gotten that yet? I assume that Viagra hasn't, based on the fact that >>it isn't even out in the U.S. yet. Is this correct? Ed, I think that it depends on the country. There may be some small less-developed countries where they accept any drug that is approved by the U.S. FDA. I may be wrong on this, but I believe that Vasomax is approved here (and maybe other places as well) as a drug for hypertension. If that is the case, M.D.s could legally prescribe it for "off-label" use in ED if there is data in support of that use. However, for a drug company to market the drug for such use, they would need to complete a Phase III clinical trial assessing both safety and effectiveness for the new use. Many drugs are used off-label for quite some time befoe getting official approval. If sildenafil (Viagra) is not protected by patent (I don't know if it is!), then Vivus should be free to use it with Muse provided that they can show its safety and efficacy. Once a drug is approved for ANY clinical use (like hypertension), the scope and extent of clinical trials needed for a new use are significantly less demanding than what is required for a wholly new drug. It's one thing for an M.D. to prescribe an off-label use of an approved drug, but a medical-device manufacturer like Vivus is not free to start selling "different flavors" of MUSE, each with a different drug cocktail. Not without doing clinical trials. Hope this helps. David

To: Evan Dimmer who wrote (4275)	1/4/1998 5:01:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 23519

Evan: <<Do Viagra (Pfizer) and Vasomax (Zonagen) have to get the same kind of approval from the individual countries too? If so, have either gotten that yet? I assume that Viagra hasn't, based on the fact that it isn't even out in the U.S. yet. Is this correct?>> Evan: The European Medicines Evaluation Agency reviews pharmaceuticals for the major European companies. Vasomax has not been submitted to any regulatory agency. Schering is currently guiding the NDA and European submissions for Vasomax. Regulatory applications for Viagra were submitted three months ago on September 29, 1997 by Pfizer to the FDA and the European Medicines Evaluation Agency. On October 21, 1997, The FDA notified Pfizer it will be giving Viagra a "priority review" . Accordingly, this review will occur sometime in the first half of 1998. Viagra is currently not approved anywhere in the world. David Chanin: The Viagra patent is owned by Pfizer with protection from generic competition for at least the next 10 years. Hope these facts are helpful! BigKNY3