Orexigen Therapeutics Concludes Light Study Patient Screening, Expecting to Randomize Approximately 9,000 Patients, and Presents

 Orexigen Therapeutics Concludes Light Study Patient Screening, Expecting to
Randomize Approximately 9,000 Patients, and Presents New Obesity Therapeutics
                               Market Research

-- At Analyst Day meeting in NYC, management highlighted Light Study next
steps, obesity therapeutics market growth potential and attractive Contrave®
preference shares --

PR Newswire

SAN DIEGO, Dec. 18, 2012

SAN DIEGO, Dec. 18, 2012 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq:
OREX), a biopharmaceutical company focused on the treatment of obesity, today
provided a clinical trial update of the Light Study as well as results of
recent market research at its Analyst Day meeting in New York City. Orexigen
reported that the screening of new patients for the Light Study, the
cardiovascular outcomes trial evaluating Contrave® (Naltrexone SR/Bupropion
SR), is now complete. Approximately 9,000 patients will be randomized in the
study within the next few weeks. An interim analysis of the Light Study will
occur after approximately 87 major adverse cardiovascular events (MACE) are
accrued in the study. Although it is still too early to predict the rate of
MACE, if the annual rate is close to the target of 1.5%, Orexigen anticipates
resubmitting the Contrave New Drug Application and conducting the interim
analysis in 2013, with potential approval as early as fourth quarter 2013.

"With great performance from our clinical sites and with the help of our
partners, including Blue Chip Marketing Worldwide, the Orexigen team deployed
several innovative strategies and tactics to enroll the Light Study in just
six and a half months," said Michael Narachi, CEO of Orexigen. "We now look
forward to 2013, when we anticipate being able to provide interim data from
the Light Study to the FDA and CHMP for review and potential approval in the
US and Europe."

Today the Company also discussed recent physician and patient market research
which was conducted to assess potential growth of the obesity therapeutics
market as well as preference shares between Contrave® and two recently
approved obesity therapeutics. The quantitative market research conducted with
1,000 physicians suggests the market for obesity therapeutics could grow 3 to
4 fold within five years from a 2012 base of approximately 7.8 million
prescriptions. The physician research also suggests that Contrave, if
approved, would be perceived favorably among the new product entrants. This
was especially true among certain important patient profiles that included
some or all of the following characteristics: female; a body mass index
between 30 and 40; and diabetes.

The Company conducted another market research study that surveyed more than
5,000 patients to assess interest levels between Contrave and the same two
recently approved obesity therapeutics. The results of this research indicate
attractive levels of patient interest for Contrave, especially across certain
important segments of the obese and overweight patient population, supporting
the physician research findings.

"Our extensive market research demonstrates the potential for the obesity
therapeutics market to grow 3 to 4 fold in the next few years as multiple new
drugs with different mechanisms of action become available, giving prescribers
and patients new tools to fight obesity," said Mark Booth, Chief Commercial
Officer of Orexigen. "We were also pleased with how Contrave performed in this
research across the most important patient demographic segments."

The webcast of the Analyst Day presentations can be accessed live on the
Investor Relations section of the Orexigen website at www.orexigen.com and
will be archived for 14 days following the Analyst Day.

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 potential to
accelerate resubmission of the Contrave NDA prior to the interim data from the
Light Study; the ability to enroll the targeted patient population; the
ability to randomize approximately 9,000 patients; 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, and timing of, approval for Contrave; and the potential that the market
research results are predictive of actual market results. 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 procedural details are not able to be worked out with the
FDA resulting in the inability to resubmit the NDA prior to the receipt of the
interim data from the Light Study; 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 recruiting and enrolling
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.

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

Media Contact:
Denise Powell
WCG
510-703-9491

SOURCE Orexigen Therapeutics, Inc.

Website: http://www.orexigen.com
 
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