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In early Sept. Vivus announced good phase III trial results from their European studies and their filing for marketing approval in the U.K. Stock hit $42. They received a $10 million payment from A B Astra for the filing. This resulted in a profitable 3rd quarter result. The FDA subsequently sent Vivus a letter stating the FDA will approve Vivus' drug in the U.S. market pending a few final issues. Today, Vivus files in Sweden. The impotence market is potentially very large and Vivus seems poised to do very well. I believe they will be the first to market with a non-injection (unlike Upjohn's Caverject) impotence drug. Pfizer's promising impotence pill (Viagra) is stil in phase III trials, with an end of 97 NDA filing at the earliest, with approval and markeing probably not begining until mid to late-98. (And while Viagra looks promising, efficacy has not been determined from phase III data. Some phase II studies had a very high placebo response rate.) With all this good news, Vivus' stock price has tumbled to $30-32 (it was in the high 29s today). Why the fall? Anyone have any information or ideas. |
