w*******r
发帖数: 118 | | m*z
发帖数: 2356 | 2 你去茶馆问他吧. 老牛在那低调的很.
【在 w*******r 的大作中提到】
: rt
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发帖数: 783 | | w*******d
发帖数: 3714 | 4 UPDATE 1-Vivus shares fall on regulatory concerns
Tue Jun 15, 2010 3:10pm EDTStocks
* Jefferies: FDA likely to focus on cardiovascular risk
* Lazard downgrades shares to "hold" from "buy"
* Qnexa FDA panel follows Avandia panel
* Shares down 8 pct in afternoon (Adds analyst comment, company comment,
updates stock price)
By Deena Beasley
LOS ANGELES, June 15 (Reuters) - Shares of Vivus Inc (VVUS.O) fell as much
as 9 percent on Tuesday after analysts raised questions about how U.S.
regulators will view the safety of its experimental weight loss drug.
The Food and Drug Administration is slated to decide by Oct. 28 whether to
approve the drug, called Qnexa, and an outside panel of experts will make
its recommendation to the agency at a July 15 hearing.
The Qnexa panel meeting will follow a two-day meeting, probably with some of
the same experts, on the safety risks of GlaxoSmithKline PLC's (GSK.L)
controversial diabetes drug Avandia.
Lazard analyst William Tanner on Tuesday downgraded shares of Vivus to "hold
" from "buy," citing the risk of an unfavorable panel review.
"We have increasing concerns about how the FDA may change the cardiovascular
safety testing standard for new drugs for obesity," Jefferies analyst
Thomas Wei said in a research note.
He said the FDA has imposed stringent cardiovascular requirements for
diabetes drugs and "it is noteworthy in itself that the FDA has invited
cardiologists to the Qnexa panel."
Wei said he spoke to a cardiologist and a psychiatrist, both of whom were
invited to be on the Qnexa panel but declined to participate. The
cardiologist said he would have voted against approval, while the
psychiatrist would have voted yes.
"I think what people are worried about is the fact that two days prior to
the Qnexa meeting they are going to be talking about Avandia and its heart
risk," said Steve Yoo, an analyst at Leerink Swann.
Vivus' Qnexa combines the generic stimulant phentermine and generic epilepsy
drug topiramate, which Johnson & Johnson (JNJ.N) sells under the brand name
Topamax. One trial showed that taking Qnexa led to weight loss of 14.7
percent over a year, compared with 2.5 percent for placebo patients.
J&J had studied Topamax as a weight loss drug, but decided not to pursue the
indication because of adverse side effects, including minor memory
impairment.
Tanner said in a research note that consultants question whether such
cognitive impairment might not sway the panel to recommend against approval.
Also, high doses of phentermine can raise blood pressure levels, but Vivus
says the low doses of both topiramate and phentermine used in Qnexa result
in much more moderate side effects.
Clinical trials have shown that Qnexa improves some risk factors for heart
disease, including decreasing blood pressure, bad cholesterol and
triglycerides, but at higher doses it also causes increases in heart rate.
"It could be a problem, but it's tough to tell," Yoo said.
A spokesman for Vivus declined to comment on the speculation.
Lazard's Tanner said a "potential fly in the ointment" is that Vivus may
have insufficient data for approval of the low and mid-level doses of Qnexa,
since one-third of clinical trial patients were treated with the higher
dose of the drug.
"Requirement of additional testing would significantly delay approval and
launch," he said in a research note.
Shares of Vivus were down 98 cents or 8.2 percent at $10.96 on the Nasdaq on
Tuesday afternoon, off an earlier low at $10.84. (Reporting by Deena
Beasley, editing by Matthew Lewis) |
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