Orexigen Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave in North America
SAN DIEGO and OSAKA, Japan, Sept. 2 /PRNewswire-FirstCall/ --
Orexigen® Therapeutics, Inc. (NASDAQ:OREX)
and Takeda Pharmaceutical Company Limited , today announced that
they have entered into an exclusive partnership to develop and
commercialize Contrave® (naltrexone SR/bupropion SR),
Orexigen's investigational drug for the treatment of obesity, in
the United States, Canada and Mexico.
Contrave is a combination therapy believed to address both
biological and behavioral drivers of obesity. The central pathways
targeted by this treatment are involved in controlling the balance
of food intake and metabolism, and regulating reward-based eating
behavior. Orexigen submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for Contrave on March 31,
2010 and the Prescription Drug User Fee Act (PDUFA) action date has
been set for January 31, 2011.
Under the terms of the agreement, Orexigen will receive an
upfront cash payment of $50 million from Takeda, and Takeda will
obtain an exclusive marketing right from Orexigen in the United
States, Mexico and Canada while Orexigen retains the right to
co-promote with Takeda in the United States. Orexigen will be
eligible to receive payments of over $1 billion upon achieving
certain regulatory and sales-based milestones. Assuming Contrave is
commercialized, Takeda will pay tiered double-digit royalty
payments on net sales in the Territory.
Under the terms of the agreement, Orexigen and Takeda will work
together on ongoing development of the product, with Orexigen
leading pre-approval activities, and Takeda leading post-approval
activities. The parties will share in the costs of any future
development of the product.
"Takeda is an ideal partner for Contrave given its proven track
record in commercializing innovative medicines and its commitment
to the treatment of obesity," said Michael Narachi, President and
CEO of Orexigen. "We believe this is a great strategic partnership
to enable our goal of a strong market entry for Contrave, if
approved. It has been our belief that getting a partner involved
early would be critical to a high-quality launch of Contrave, and
with this partnership now in place, we are tightly focused on the
regulatory review process and securing approval for
"Contrave represents an important addition to Takeda's
cardiovascular and metabolic disease franchise and we look forward
to partnering with Orexigen," said Shinji Honda, President and CEO
of Takeda Pharmaceuticals North America, Inc., a wholly-owned
subsidiary of Takeda that has commercial responsibility for the
Americas. "Takeda has deep experience in providing important
medicines to treat chronic disease and Contrave will help us
provide a full spectrum of treatment to patients for the management
Approximately 75 million Americans suffer from obesity and that
number is expected to rise to 103 million by 2018. Obesity is a
chronic condition linked to serious medical consequences including
type 2 diabetes, cardiovascular disease, cancer and depression.
Despite increasing public health concerns regarding obesity,
two-thirds of the U.S. adult population is overweight or obese.
Although weight loss of 5-10 percent may improve overall health,
including blood sugar control, high blood pressure, high
cholesterol, and overall quality of life, many individuals are not
able to lose weight or maintain weight loss with diet and exercise
Conference Call Today at 8:00 a.m. Eastern Time (5:00 a.m.
The Orexigen management team will host a teleconference and
webcast to discuss the partnership. The live call may be accessed
by phone by calling (866) 314-5232 (domestic) or (617) 213-8052
(international), participant code 19096068. The webcast can be
accessed live on the investor relations section of the Orexigen web
site at http://www.orexigen.com/, and will
be archived for 14 days following the call.
Contrave is an investigational combination therapy believed to
address both biological and behavioral drivers of obesity. The two
components of this combination therapy act in a complementary
manner in the central nervous system. The central pathways targeted
by this treatment are involved in controlling the balance of food
intake and metabolism, and regulating reward-based eating behavior.
In clinical trials, Contrave was shown to help obese patients
initiate and sustain significant weight loss, improve important
markers of cardiometabolic risk and increase ability to control
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of obesity. The Company has filed an NDA
with the FDA for its lead investigational product, Contrave®.
The Company's second product, Empatic(TM), has completed 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,
through combination therapeutic approaches. Further information
about the Company can be found at www.orexigen.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global
company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of
the industry, Takeda is committed to strive towards better health
for patients worldwide through leading innovation in medicine.
Additional information about Takeda is available through its
corporate website, www.takeda.com.
About Takeda Pharmaceuticals North America, Inc. and Takeda
Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America,
Inc. and Takeda Global Research & Development Center, Inc. are
subsidiaries of Takeda Pharmaceutical Company Limited, the largest
pharmaceutical company in Japan. The respective companies currently
market oral diabetes, insomnia, rheumatology and gastroenterology
treatments and seek to bring innovative products to patients
through a pipeline that includes compounds in development for
diabetes, cardiovascular disease, gastroenterology, neurology and
other conditions. To learn more about these Takeda companies, visit
Forward-Looking Statements Related to Orexigen
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" 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 for, and timing of, approval for Contrave,
the Company's belief that this product candidate may be an
important therapeutic option in the treatment of obesity, the
potential milestone and royalty payments under the agreement with
Takeda and the potential strength of our market entry with
Contrave, if approved. 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:
Orexigen's dependence on Takeda for aspects of the development and
commercialization of Contrave; the potential for the FDA to delay
the scheduled PDUFA action date of January 31, 2011 due to the
FDA's internal resource constraints or other reasons; the
uncertainty of the FDA approval process and other regulatory
requirements; the FDA may not agree with the Company's
interpretation of efficacy and safety results; the FDA may require
Orexigen to complete additional clinical, non-clinical or other
requirements prior to the approval of the Contrave NDA; the
therapeutic and commercial value of Contrave; reliance on third
parties to assist with the development of Contrave and the
regulatory submissions related thereto; the potential for adverse
safety findings relating to Contrave; 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, which was filed with the Securities Exchange Commission
on August 6, 2010 and is available from the SEC's website
(www.sec.gov) and on our 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.
Forward-Looking Statements Related to Takeda
This press release contains forward-looking statements regarding
the Company's plans, outlook, strategies, and results for the
future. All forward-looking statements are based on judgments
derived from the information available to the Company at this time.
Forward looking statements can sometimes be identified by the use
of forward-looking words such as "may," "believe," "will,"
"expect," "project," "estimate," "should," "anticipate," "plan,"
"continue," "seek," "pro forma," "potential," "target, "
"forecast," or "intend" or other similar words or expressions of
the negative thereof. Certain risks and uncertainties could cause
the Company's actual results to differ materially from any forward
looking statements contained in this press release. These risks and
uncertainties include, but are not limited to, (1) the economic
circumstances surrounding the Company's business, including general
economic conditions in the US and worldwide; (2) competitive
pressures; (3) applicable laws and regulations; (4) the success or
failure of product development programs; (5) decisions of
regulatory authorities and the timing thereof; (6) changes in
exchange rates; (7) claims or concerns regarding the safety or
efficacy of marketed products or product candidates; and (8)
integration activities with acquired companies.
Source: Orexigen Therapeutics, Inc.
CONTACT: investors, Graham Cooper, Chief Financial Officer of
+1-858-875-8600; or media, Liz Frank, +1-212-301-7216, or Carolyn Wang,
+1-415-225-5050, both of WCG for Orexigen Therapeutics, Inc.; or Seizo Masuda,
81-3-3278-2037, or Kara Hoeger, Takeda Pharmaceuticals North America, Inc.,
+1-224-554-1277, both of Takeda Pharmaceutical Company Limited
Posted: September 2010