UPDATE 3-Vivus says erectile dysfunction trial meets goals

2009年 11月 19日 星期四 04:59 BJT
 

* 57 pct of 100mg/200mg avanafil patients have intercourse

* Intercourse achieved in 30 minutes or less

* Two other Phase 3 trials underway

* FDA filing late 2010 or early 2011

* Shares rise 2.8 percent (Adds Eli Lilly comment, updates share price)

By Deena Beasley

LOS ANGELES, Nov 18 (Reuters) - The erectile dysfunction drug being developed by Vivus Inc (VVUS.O: 行情) met the goals of a late-stage trial and was shown to be effective in 30 minutes or less, the company said on Wednesday.

The 646-patient trial found that about three-quarters of patients taking either a 100 mg or a 200 mg dose of the drug, avanafil, had erections sufficient for intercourse. Fifty-seven percent experienced "successful intercourse," compared with 27 percent of placebo patients.

Avanafil works by inhibiting the PDE5 enzyme, the same target as Pfizer Inc's (PFE.N: 行情) Viagra and Eli Lilly and Co's (LLY.N: 行情) Cialis. But Vivus said it was designed to act faster than the two other drugs.

Sales of current erectile dysfunction therapies total more than $3.5 billion a year.

"There's no question in our mind that these are indeed positive data that reaffirm the drug's differentiating attributes (primarily faster onset of action) relative to other PDE5 inhibitors currently on the market," J.P. Morgan analyst Cory Kasimov said in a research note.

But he expressed skepticism about avanafil's commercial opportunity given the brand awareness of the competition and the fact that Viagra's patent will expire in 2012, clearing the way for lower-cost generic versions of the drug.

According to Leerink, Swann and Co analyst Steve Yoo, shares of Vivus rose more than 9 percent on Tuesday after the StreetAccount trading service issued a report citing "vague rumors circulating" that regulatory approval for Vivus' experimental weight loss drug, Qnexa, was imminent, even though the Qnexa application has not yet been filed.

Vivus said late on Tuesday that it would announce the avanafil data on Wednesday morning, and shares rose further in after hours trading.

StreetAccount also said that Vivus had previously been the target of takeover rumors.

"They had said the avanafil data would be released in the fourth quarter and confirmed the release in the afternoon," said Yoo. "But does the world really need another PDE5 inhibitor?"

Shares of Vivus were up 2.8 percent at $8.81 in late afternoon trading on Nasdaq.

"ON DEMAND THERAPY"

"For patients in all market research studies, their No. 1 desire is for an on-demand therapy," said Vivus Chief Executive Officer Leland Wilson.

"Patients want to have sex sooner rather than later," Wilson said.   待续

 
 

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