Orexigen Therapeutics Announces Progress with FDA on a Faster Path to Resubmission of the Contrave NDA

    Orexigen Therapeutics Announces Progress with FDA on a Faster Path to
                       Resubmission of the Contrave NDA

-Commercialization preparation also advances with planned initiation of Ignite
Study-

PR Newswire

SAN DIEGO, Jan. 7, 2013

SAN DIEGO, Jan. 7, 2013 /PRNewswire/ -- Orexigen^® Therapeutics, Inc. (Nasdaq:
OREX), a biopharmaceutical company focused on the treatment of obesity, today
announced progress with the United States Food and Drug Administration (FDA)
on a faster path to resubmission of the Contrave^® (naltrexone SR / bupropion
SR) New Drug Application (NDA).

Consistent with the spirit of the formal dispute resolutionrequest (FDRR)
responseletter issued to the Company in October by the FDA's Center for Drug
Evaluation and Research, the Division of Metabolism and Endocrinology Products
(DMEP) has proposed a resubmission procedure that allows the independent Data
Monitoring Committee's summary report of the Light Study interim analysis to
form the basis of the resubmission of the Contrave NDA. The complete clinical
study report (CSR) for the interim analysis, which would ordinarily form the
basis for the NDA resubmission filing, would be supplied to the FDA during the
review within 60 days of the NDA resubmission.

The Data Monitoring Committee will conduct the interim analysis after at least
87 major adverse cardiovascular events (MACE) are adjudicated in the Light
Study. The timing of the interim analysis is dependent upon the rate of MACE
in the Light Study. Although the annual MACE rate is still too early to
predict, if it is close to the target of 1.5%, Orexigen anticipates conducting
the interim analysis and resubmitting the Contrave NDA in the second half of
2013 with potential approval in early 2014.

"We are pleased that our continuing discussions with the FDA have resulted in
a proposal by DMEP which expedites resubmission while also allowing the Agency
the time it needs to review the Contrave NDA resubmission," said Michael
Narachi, CEO of Orexigen.

Orexigen also announced continued preparation for commercialization of
Contrave, if approved, with plans to initiate the Ignite Study, a randomized
open-label clinical trial designed to provide additional information regarding
the real world weight loss potential of Contrave therapy with a commercially
available comprehensive lifestyle intervention program versus usual care.
Orexigen plans to initiate randomization of approximately 200 patients into
the Ignite Study later this quarter.

"2013 promises to be a pivotal year for Orexigen," Narachi continued. "We
expect to receive cardiovascular data from the Light Study, to file for
approval in the U.S. and Europe, and to provide additional information about
Contrave's real world potential with the Ignite Study."

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the
treatment of obesity. The Company's lead product candidate is Contrave^®,
which has completed Phase III clinical trials and for which a New Drug
Application has been submitted and reviewed by the FDA. The Company has also
reached agreement with the FDA on a Special Protocol Assessment (SPA) for the
Light Study, the Contrave cardiovascular outcomes trial. The Company's other
product candidate, Empatic™, has completed Phase II clinical trials. Further
information about the Company can be found at www.orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are
not a description of historical facts are forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "indicates," "should,"
"will," "intends," "potential," "suggests," "assuming," "designed" and similar
expressions are intended to identify forward-looking statements. These
statements are based on the Company's current beliefs and expectations. These
forward-looking statements include statements regarding the possibility of
resubmitting the Contrave NDA with the DMC report on the interim analysis and
without the clinical study report for the interim analysis; the potential to
accelerate the timing of the review of the Contrave NDA; the potential for,
and timing of, the accrual and adjudication of MACE and the potential
resubmission of the Contrave NDA; the safety and effectiveness of Contrave;
the potential for past Contrave clinical trials to predict the outcome of
future Contrave clinical trials; the potential to demonstrate the real world
weight loss potential of Contrave with a commercially available comprehensive
lifestyle intervention program; and the potential for, and timing of, approval
for Contrave. The inclusion of forward-looking statements should not be
regarded as a representation by Orexigen that any of its plans will be
achieved. Actual results may differ from those set forth in this release due
to the risk and uncertainties inherent in the Orexigen business, including,
without limitation: the possibility that the FDA determines not to initiate
review of the Contrave NDA until it has received the complete study report for
the interim analysis; the SPA is not binding on the FDA if public health
concerns unrecognized at the time the SPA agreement was entered into become
evident, other new scientific concerns regarding product safety or efficacy
arise, or if Orexigen fails to comply with the agreed upon trial protocol;
Orexigen's ability to conduct the Light Study and the progress and timing
thereof, including risks associated with enrolling the appropriate patients in
the Light Study; Orexigen's ability to demonstrate in the Light Study that the
risk of MACE in overweight and obese subjects treated with Contrave does not
adversely affect the product candidate's benefit-risk profile; the potential
that earlier clinical trials may not be predictive of future results in the
Light Study; the potential for the FDA to not approve Contrave even after the
resubmission with the MACE event data; the potential for the Light Study to
cost more than what is projected; the potential for early termination of the
collaboration agreement between Orexigen and Takeda; the costs and time
required to complete additional clinical, non-clinical or other requirements
prior to any resubmission of an NDA; the therapeutic and commercial value of
Contrave; Orexigen's ability to maintain sufficient capital; and other risks
described in the Company's filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof, and
Orexigen undertakes no obligation to revise or update this news release to
reflect events or circumstances after the date hereof. Further information
regarding these and other risks is included under the heading "Risk Factors"
in Orexigen's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission November 9, 2012 and which is available from the SEC's
website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the
heading "Investor Relations." All forward-looking statements are qualified in
their entirety by this cautionary statement. This caution is made under the
safe harbor provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.

Source:
Orexigen Therapeutics
McDavid Stilwell
Vice President, Corporate Communications & Business Development
858-875-8600

SOURCE Orexigen Therapeutics, Inc.

Website: http://www.orexigen.com
 
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