- Patent Covers Methods of Use for Bupropion and Naltrexone in Obesity - SAN DIEGO, Oct. 14
SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics,
Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of
obesity and other central nervous system-related disorders, today announced
that it has received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for what the Company refers to as the "Weber/Cowley
methods patent" (U.S. patent application no.11/356,839) which provides
coverage for Contrave(R), the Company's lead obesity product candidate now in
Phase 3 clinical trials.
Upon issuance, the patent will broadly cover methods of treating obesity
with combinations of bupropion and naltrexone, the two active agents in
Contrave. It is a companion to the Weber/Cowley composition patent (U.S.
7,375,111) which was issued by the USPTO in May 2008, which broadly covers
sustained release (SR) compositions of bupropion and naltrexone combined in a
single dosage form. It is anticipated that the Weber/Cowley methods patent
will provide protection for Contrave through mid 2024.
"This patent represents another successful milestone for Orexigen. Upon
issuance, Contrave would be protected by four patents that collectively will
provide broad intellectual property coverage," said Orexigen President and
CEO, Gary Tollefson, M.D., Ph.D. "With this additional patent allowance, we
have added another layer of protection in support of Contrave which we believe
enhances its net present value."
Contrave is an investigational weight loss medication with a mechanism of
action that works at two sites within the central nervous system. The first
is a hypothalamic site that controls the balance of food intake and
metabolism. We believe that Contrave is possibly the first treatment for
obesity to address a second site, the reward systems in the brain that are
associated with food preference and food cravings. In clinical trials,
Contrave has initiated and sustained significant weight loss over one year of
treatment (approximately 8-10.7% in patients completing 48 weeks of therapy)
we believe by reducing appetite, increasing metabolism and offsetting the
body's natural tendency to fight back and slow down the weight loss process.
We expect to announce data from the first of our Contrave Phase 3 trials in
January of 2009 and the remaining three trials by mid next year.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the
treatment of obesity and other central nervous system-related disorders. The
Company's lead combination product candidates targeted for obesity are
Contrave, which is in Phase 3 clinical trials, and Empatic(TM), which is in
the later stages of Phase 2 clinical development. Each product candidate is
designed to act on a specific group of neurons in the central nervous system
with the goal of achieving appetite suppression and sustained weight loss.
Beyond obesity, Orexigen is developing drug combinations for use in
schizophrenia and obsessive-compulsive disorder. Further information about
the company can be found at http://www.Orexigen.com.
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,"
"will," "intends," "potential," "suggests," "assuming," "designed," "projects"
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 enrollment,
timing, execution and completion of clinical trials of Contrave, the timing of
an NDA submission with the FDA for Contrave, the efficacy and safety of
Contrave, the potential to obtain regulatory approval for, and effectively
treat obesity with, Contrave, and the potential issuance of patents and the
scope and duration of protection of issued patents relating to the Company's
product candidates. 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 Company's business, including,
without limitation: the progress and timing of the Company's Contrave clinical
trials or the development of Contrave; the potential that earlier clinical
trials may not be predictive of future results; the potential for adverse
safety findings relating to Contrave to delay or prevent regulatory approval
or commercialization, or result in product liability claims; Orexigen or its
licensors may not be able to obtain, maintain and successfully enforce
adequate patent and other intellectual property protection of its product
candidates; and other risks described in the Company's filings with the
Securities and Exchange Commission (SEC). 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. 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, Inc.
