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发帖数: 5516 | | v**********m
发帖数: 5516 | 2 Orexigen Therapeutics, Inc. And FDA Identify Clear And Feasible Path to
Approval for Contrave
4:00pm EDT
Orexigen Therapeutics, Inc. announced that following a recent meeting with
senior officials in FDA's Office of New Drugs (OND), the Company received
written correspondence detailing OND's design requirements for a
cardiovascular outcomes trial (CVOT) for Contrave that would address the
Complete Response Letter (CRL) received in January 2011 . Orexigen believes
that these design requirements are reasonable and feasible and provide the
certainty required to reinitiate development of Contrave. Importantly, FDA
stated that "if the interim analysis meets the specified criteria to exclude
an unacceptable increased cardiovascular (CV) risk, the drug could be
approved. | v**********m
发帖数: 5516 | 3 Orexigen Revives Obesity Drug Development With FDA Agreement
Q
By Ryan Flinn - Sep 20, 2011 4:38 PM ET
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Orexigen Therapeutics Inc. (OREX) is renewing development of the
experimental obesity drug Contrave after reaching an agreement with U.S.
regulators to further study heart risks.
Orexigen, one of three companies with rival obesity treatments competing for
approval, will start a two-year clinical trial of about 10,000 patients in
the first half of next year, aiming to receive clearance for Contrave from
the Food and Drug Administration in 2014, the La Jolla, California- based
company said today in a statement.
“It’s very positive news,” Michael Narachi, Orexigen president and chief
executive officer, said in an interview. “This drug, which we always
believed could benefit patients, has a clear path to market.”
Orexigen announced June 3 it would halt U.S. development of Contrave after
the FDA said a large study on heart risks would be required before the drug
could be approved -- a move the company called “unprecedented.”
Orexigen and partner Takeda Pharmaceutical Co. of Osaka, Japan, has been
vying with Mountain View, California-based Vivus Inc. (VVUS) and Arena
Pharmaceuticals Inc. (ARNA) of San Diego to introduce the first new obesity
medicine in the U.S. in more than a decade.
Shares Rise
Orexigen gained 63 percent to $2.40 at 4:33 p.m. New York time in extended
trading after the company’s shares were unchanged at $1.47 at the close of
Nasdaq Stock Market composite trading. Arena rose as much as 17 percent to $
1.69 and Vivus increased 5.5 percent to $9.10 in extended trading.
Orexigen’s shares had declined 75 percent in the past 12 months.
Last week, the FDA agreed to reconsider Vivus’s drug, Qnexa, for the
treatment of obese men and women who don’t have the potential for having
children. Under the agreement, Vivus will resubmit Qnexa by the end of next
month, with the FDA scheduling an advisory panel in the first quarter of
next year. A final decision on whether the drug is approved would come in
the second quarter of 2012, Vivus said.
Arena’s medicine, lorcaserin, was rejected by the FDA last October. The
agency requested more data after a rat study showed a possible link to brain
tumors. The company and its development partner Tokyo-based Eisai Co. said
in August that a study showed concentrations of their weight-loss pill were
lower in human brains than in rat models.
Seeking Partner
Contrave’s study won’t have the same patient restrictions as Vivus’s
Qnexa, Narachi said. The company, which had $70 million in cash at the end
of the last quarter, will look for a partner to help shoulder the cost of
the new trial, in exchange for commercial rights outside of North America.
Previous studies showed that two Contrave tablets taken two times a day
helped twice as many patients in studies lose at least 5 percent of their
weight compared with a placebo after 56 weeks, meeting one of two FDA
guidelines for approval of diet pills. The product is a combination of two
marketed drugs that target different parts of the brain influencing appetite
and cravings.
Contrave increases blood pressure, a risk seen with Abbott Laboratories pill
Meridia. The agency pulled Meridia from the market last year after it was
tied to heart attacks and strokes in a study.
While the FDA is planning to ask an advisory committee to review the general
requirements for heart safety and diet bills, any recommendations won’t
affect the agency’s agreement with Orexigen on Contrave, the company said
in its statement.
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn
@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@
bloomberg.net | K*******n
发帖数: 1466 | 4 明天开盘10-15分钟之后应该会有一个dip的吧？到时候是否可以上去玩玩？ | K*******n
发帖数: 1466 | | v**********m
发帖数: 5516 | 6 the risk is high now. ymyd
【在 K*******n 的大作中提到】
: 明天开盘10-15分钟之后应该会有一个dip的吧？到时候是否可以上去玩玩？
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