SAN DIEGO, Nov. 13, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced that its wholly
owned subsidiary, Orexigen Therapeutics Ireland Ltd., and
Merck KGaA, Darmstadt, Germany have executed a distributorship
agreement for Contrave® (naltrexone HCl / bupropion HCl extended
release) in Latin America,
including Brazil and Mexico. Under the terms of the
agreement, Merck KGaA, Darmstadt, Germany will be responsible for all
commercialization and regulatory activities and will own marketing
authorization in the region. Orexigen will receive an upfront
payment and other potential regulatory and sales milestones,
which have not been disclosed. In addition, Orexigen will be
responsible for product supply.
Headquartered in Darmstadt, Germany, Merck KGaA is a leading science and
technology company in healthcare, life science and performance
materials.
"The well-established position of Merck KGaA, Darmstadt,
Germany in Latin America, combined with their experience
in treating complications that result from patients who are
overweight or struggling with obesity makes them an ideal partner
to bring Contrave to the region," said Dr. Thomas Cannell,
EVP, Chief Operating Officer and President of Global Commercial
Products of Orexigen. "We look forward to working closely
with them to further commercialize Contrave. We now have
partnerships covering 67 countries worldwide, including
Brazil and Mexico with this agreement, and are committed
to leveraging our alliance management capabilities to help combat
the global rise of obesity rates."
The prevalence of patients who are overweight or struggling with
obesity is rapidly increasing in Latin
America. Approximately 56% of adults in Latin America are considered overweight or
struggling with obesity, compared to a global average of
34%.1 From 2016 to 2025, the percentage of
patients struggling with obesity in Brazil is expected to increase from 19.2% to
25.2% in adult men, and from 26.4% to 31.8% in adult women.
Over the same time period, the percentage of patients struggling
with obesity in Mexico is expected
to increase from 25.1% to 31.3% in adult men, and from 34.0% to
39.3% in adult women.2
"We, as Merck, have a long-standing experience with endocrine
and cardiometabolic diseases in Latin
America, and we remain dedicated to bringing additional
innovative healthcare solutions to patients," said Francois Feig, SVP, Head of the Global Business
Franchise General Medicine & Endocrinology. "With
Contrave, we will be offering a novel therapeutic alternative that
can help address the healthcare needs of the growing number of
patients in the region, who are overweight or suffering from
obesity."
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany,
is a leading science and technology company in healthcare, life
science and performance materials. Around 50,000 employees
work to further develop technologies that improve and enhance life
- from biopharmaceutical therapies to treat cancer or multiple
sclerosis, cutting-edge systems for scientific research and
production, to liquid crystals for smartphones and LCD televisions.
In 2016, Merck KGaA, Darmstadt, Germany, generated sales of € 15.0 billion in
66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical
and chemical company. The founding family remains the
majority owner of the publicly listed corporate group. Merck
KGaA, Darmstadt, Germany, holds
the global rights to the "Merck" name and brand except in
the United States and Canada, where the company operates as EMD
Serono, MilliporeSigma and EMD Performance Materials.
About Contrave
Contrave, approved by the FDA in September 2014, is indicated for use as an
adjunct to a reduced-calorie diet and increased physical activity
for chronic weight management in adults with an initial body mass
index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater
(overweight) in the presence of at least one weight-related
comorbid condition (e.g., hypertension, type 2 diabetes mellitus or
dyslipidemia). Orexigen is committed to helping eligible
patients learn about Contrave and recommends patients visit
www.contrave.com for additional information.
For more information and full prescribing information please
visit www.contrave.com.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company
focused on the treatment of weight loss and obesity. The
company's mission is to help improve the health and lives of
patients struggling to lose weight. Orexigen's first product,
Contrave® (naltrexone HCl and bupropion HCl extended release), was
approved in the U.S. in September 2014. In the European
Union, the medicine has been approved under the brand name Mysimba™
(naltrexone HCl/ bupropion HCl prolonged release). Millions around
the globe continue to face challenges of weight loss.
Orexigen is undertaking a range of development and
commercialization activities, both on its own and with strategic
partners, to bring Contrave / Mysimba to patients around the world.
As a patient-centric company, Orexigen continues to focus not
only on innovating medicine for the treatment of obesity, but to
also offer unique resources and healthcare delivery options to
improve the patient experience. Further information about
Orexigen can be found at www.orexigen.com.
Mysimba™ and Contrave® are trademarks of Orexigen Therapeutics,
Inc.
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," "will," "should,"
"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 success of
marketing and commercialization of Contrave/Mysimba in the United States and elsewhere including
Latin America; the potential for
and timing of commercial launches in Latin America and countries outside of the
U.S.; and the potential growth of Contrave/Mysimba sales.
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 materially from those
expressed or implied in this release due to the risk and
uncertainties inherent in the Orexigen business, including, without
limitation: the potential that the marketing and commercialization
of Contrave/Mysimba will not be successful; the company's ability
to obtain and maintain partnerships and the ability of it or its
partners to maintain marketing authorization globally; the
company's ability to adequately inform consumers about Contrave;
the company's ability to successfully commercialize Contrave with a
specialty sales force in the United
States; the capabilities and performance of various third
parties on which it relies for a number of activities related to
the manufacture, development and commercialization of
Contrave/Mysimba; the estimates of the capacity of manufacturing
and the company's ability to secure additional manufacturing
capabilities; the company's ability to successfully complete the
post-marketing requirement studies for Contrave; the therapeutic
and commercial value of Contrave/Mysimba; competition in the global
obesity market, particularly from existing therapies; the company's
failure to successfully acquire, develop and market additional
product candidates or approved products; the company's ability to
obtain and maintain global intellectual property protection for
Contrave and Mysimba; the potential for an appeals court to
determine in the company's patent litigation matter with Actavis
that one or more of its patents is not valid or that Actavis'
proposed generic product is not infringing each of the patents at
issue; other legal or regulatory proceedings against Orexigen, as
well as potential reputational harm, as a result of misleading
public claims about Orexigen; the company's ability to maintain
sufficient capital to fund its operations for the foreseeable
future; the company's ability to satisfy covenants in the
indentures for its outstanding indebtedness, including one
requirement that the company generate consolidated net product
sales of least $100 million for
fiscal 2017; the company's ability to satisfy the applicable
listing standards of the NASDAQ Global Market; and other risks
described in Orexigen'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 will be
included under the heading "Risk Factors" in Orexigen's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on or about November 13, 2017 and its other
reports, which are available from the SEC's website (www.sec.gov)
and on Orexigen's website (www.orexigen.com) under the heading
"Investors." 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.
References:
1. Reuters
//http://www.reuters.com/article/2015/02/13/us-latam-obesity
2. 2017 NCD Risk Factor Collaboration-
http://ncdrisc.org/data-visualisations-adiposity.html
Contacts:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com
Erika Hackmann
Y&R PR (Media Contact for Orexigen)
+1-917-538-3375
erika.hackmann@yr.com
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SOURCE Orexigen Therapeutics, Inc.