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Vivus Wins FDA Approval


Amgen, Furiex, Takeda face rejection while Salix and Progenics get delayed.

MINYANVILLE ORIGINAL Vivus (VVUS) shareholders got a piece of good news late last week when the Food and Drug Administration approved the company's drug Stendra for erectile dysfunction. But another impotence pill is not the news that's going to have a big impact on this stock. Cowen Group analyst Simos Simeonidis estimates the drug may fetch $300 million if Vivus licenses or sells it to another company. Vivus doesn't have a sales force to sell the pill and it needs to focus on the big prize, which is winning US approval of its diet pill Qnexa. Investors were anticipating a decision on market clearance in April but the FDA delayed doing so until July 17. "The majority of the value associated with Vivus still lies with Qnexa," Leerink Swann analyst Steve Yoo says.

In other news in April, Amgen's (AMGN) attempt to win expanded use for its bone-healing drug Xgeva was rejected by the FDA. The agency said risks outweighed the benefits for patients with advanced prostate cancer. Xgeva is an important new product to Amgen with fast-growing sales. The rejection news was expected and Amgen shares actually rose slightly after the disclosure. A diabetes treatment developed by Furiex Pharmaceuticals (FURX) and Takeda (TKPYY.PK) also was rejected in April. (Furiex shares tanked on the news.) The FDA delayed a decision on expanded use of Relistor, marketed by Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX). Finally, Gilead Sciences (GILD) and Abbott Laboratories (ABT) are the big winners following the release of study results for experimental hepatitis C drugs. Gilead, in particular, is seen by Wall Street as the company to beat for a much-improved, next-generation hepatitis treatment. Shares of Gilead are up more than 26% this year, trading Monday at $51.76.

(See: Vivus Awaits Decisions on Two Drug Approvals in April.)

Twitter: @brettchase

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