SAN DIEGO, Aug. 7, 2017 /PRNewswire/ -- Orexigen
Therapeutics, Inc. (Nasdaq: OREX) today announced that its wholly
owned subsidiary, Orexigen Therapeutics Ireland Ltd., and
Cheplapharm Arzneimittel GmbH have executed a distributorship
agreement covering Germany,
France and Austria for Mysimba™ (naltrexone HCl /
bupropion HCl prolonged release). Under the terms of the
agreement, Cheplapharm will be responsible for all
commercialization activity and expenses. Orexigen will supply
Mysimba to Cheplapharm for a negotiated transfer price.
Cheplapharm Arzneimittel GmbH is a pharmaceutical company
headquartered in Greifswald, Germany with subsidiaries in France and the U.S. that holds more than 150
marketing authorizations in more than 100 countries worldwide.
"Cheplapharm's strong capabilities in weight management therapy
and established relationships in the market make them an ideal
partner to bring Mysimba to patients in Germany, France and Austria," said Dr. Thomas Cannell, EVP, Chief Operating Officer and
President of Global Commercial Products of Orexigen. "With
this agreement, we now have partnerships covering 48 countries
worldwide. In Europe, Mysimba has now launched in 16
countries, and we expect to launch in up to eight more countries by
year end."
"We are excited about our partnership with Orexigen and are
dedicated to using our experience to help bring Mysimba to patients
struggling with their weight and obesity in Germany, France and Austria," said Sebastian Braun, Cheplapharm's Chief Executive
Officer.
Obesity and related comorbidities are a significant health
problem across Europe, including
the combined population of 150 million people in Germany, France and Austria. The percentage of
the adult population struggling with obesity in these countries is:
Germany (20%), France (18%) and Austria (21%), which represents a significant
number of individuals in these large markets. On average,
more than 50% of the adult population in these countries are
overweight.i
About Cheplapharm Arzneimittel GmbH
Cheplapharm Arzneimittel GmbH was founded in 1998, with its
company headquarters situated in Greifswald since the end of 2014.
Its subsidiaries are based in Hamburg and Englewood in New
Jersey, USA (15 miles from New
York). With a team of experienced experts,
Cheplapharm's aim is to offer high-quality medications, dietary
supplements, and cosmetics on the market. These products are
manufactured under state-of-the-art conditions and strict quality
control. Cheplapharm sees itself as a provider of specialty
pharma. The focus lies on active ingredient markets and
clinical pictures that are too small for pharma corporate groups
and generic producers. It is thus possible for Cheplapharm to
offer customers highly individual products. In many
pharmaceutical forms and active ingredient markets, Cheplapharm has
a unique position. Cheplapharm holds more than 300
authorizations in more than 100 countries worldwide and has
extensive experience in collaborating with our global distribution
and marketing partners. Currently, Cheplapharm employs 180
highly qualified staff members and, together with its subsidiaries,
generates an annual turnover of 200 million
euros.
About Mysimba
Mysimba is a prescription-only weight-loss medication believed
to work on two areas of the brain—the hunger center and the reward
system—to reduce hunger and help control cravings. The exact
neurochemical effects of Mysimba leading to weight loss are not
fully understood. Mysimba contains two medicines, bupropion,
a relatively weak inhibitor of the neuronal reuptake of dopamine
and norepinephrine and naltrexone, an opioid antagonist.
Mysimba is approved in the European Union 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
comorbidity (e.g., hypertension, type 2 diabetes mellitus or
dyslipidemia). In the U.S., the medicine has been approved
under the brand name Contrave.
Please see Summary of Product Characteristics and
more information about MYSIMBA for EU patients available
at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003687/human_med_001845.jsp&mid=WC0b01ac058001d124
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 our current beliefs
and expectations. These forward-looking statements include
statements regarding: the potential for regulatory approvals and
local product registrations for Mysimba in Germany, France and Austria; the expectation for additional
ex-U.S. commercial alliances in the future; and the potential for
and timing of commercial launches in other countries outside the
U.S. 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 capabilities of our
existing distribution partners and the ability to obtain
partnerships and marketing authorizations globally; competition in
the global obesity market, particularly from existing therapies;
the therapeutic and commercial value of Contrave/Mysimba; our
ability to retain ownership of Contrave/Mysimba and create value in
certain markets outside of the United
States; legal or regulatory proceedings against Orexigen;
our ability to maintain sufficient capital to fund our operations
for the foreseeable future; 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, except as
required by law. Further information regarding these and
other risks is included under the heading "Risk Factors" in
Orexigen's Quarterly Report on Form 10-Q to be filed with
the Securities and Exchange Commission on or
about August 10, 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.
Orexigen Contact:
Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
jkeyes@orexigen.com
Media Contact:
Erika Hackmann
Y&R
+1-917-538-3375
erika.hackmann@yr.com
i Kompetenzzentrum Adipositas; IGES Institut;
Weißbuch Adipositas, DAG, World Bank
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SOURCE Orexigen Therapeutics, Inc.