* Says Contrave may be approved in 2014, if study succeeds
* Contrave could trail rival Vivus diet pill by years
* Orexigen shares jump 87 pct after hours
* Vivus rises 3.8 pct; Arena shares little changed
(Adds analyst comment, updates shares of Orexigen, rivals)
By Ransdell Pierson
NEW YORK, Sept 20 Orexigen Therapeutics Inc
(OREX.O) said it plans in 2012 to begin a large heart-safety
trial of its experimental Contrave obesity drug, and that
favorable results could win over regulators who rejected the
pill early this year.
Orexigen, whose shares jumped 87 percent in after-hours
trading, said its pill could be approved as soon as 2014 if the
study involving thousands of patients resolves concerns about
the drug's cardiovascular safety.
"We're still three years and a hundred million dollars away
from approval, but we've just gone from a company on the brink
of disintegration to something that should yield outsize
returns for those willing to be patient," said Jefferies & Co
analyst Corey Davis.
Despite improved prospects for Contrave, if approved it
could be several years behind Qnexa, a rival weight loss pill
being developed by Vivus Inc. (VVUS.O) Vivus last week said it
plans to resubmit by October a U.S. marketing application for
its product, which the U.S. Food and Drug Administration
spurned a year ago, also due to heart-safety concerns.
The FDA in January said it could not approve Orexigen's
pill, citing Contrave's cardiovascular effects when used
long-term in a population of overweight and obese subjects.
The agency told Orexigen it must first conduct a study "of
sufficient size and duration" to demonstrate that the risk of
heart attacks, strokes and other major cardiovascular events
does not undermine the drug's risk-benefit profile.
Orexigen said on Tuesday that it and its partner Takeda
Pharmaceutical Co Ltd (4502.T) are satisfied with design
requirements for the required cardiovascular safety trial that
had been suggested recently by FDA officials.
San Diego-based Orexigen said the study would require
thousands of patients, and that interim results could be
obtained less than two years after the trial begins in the
first half of 2012.
The company said the FDA notified it Contrave could be
approved before the trial is completed, if the interim analysis
of data "exclude an unacceptable increased cardiovascular
Contrave combines naltrexone, a medicine used to fight
alcohol and drug addiction, with the antidepressant bupropion.
It is intended to boost metabolism while curbing appetite and
cravings. Japan's Takeda holds North American marketing rights
Before Contrave was rejected in late January, BioMedTracker
had projected Contrave sales could reach $1.2 billion by 2018
if the drug reached the market.
Wall Street has also had to scale back initial high hopes
for another experimental diet drug pill, Arena Pharmaceuticals
Inc's (ARNA.O) lorcaserin. The FDA rejected the product last
October due to safety concerns.
Shares of Orexigen rose to $2.75, from a closing price of
$1.47 Tuesday on the Nasdaq. But they were trading at more than
$11 in late 2010, before Contrave was rejected by the FDA.
Vivus shares rose 3.8 percent to $8.95, from their closing
price of $8.62, also on the Nasdaq. Shares of Arena were little
(Reporting by Ransdell Pierson; Editing by Richard Chang,
Matthew Lewis and Gunna Dickson)