Orexigen Therapeutics Announces Commercialization and Distributorship Arrangement with Cheplapharm Arzneimittel GmbH for Mysimba™ in Germany, France and Austria

Monday, August 7, 2017 General News
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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 KeyesChief Financial OfficerOrexigen Therapeutics, Inc. [email protected]

Media Contact: Erika HackmannY&[email protected]

i Kompetenzzentrum Adipositas; IGES Institut; Weißbuch Adipositas, DAG, World Bank

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SOURCE Orexigen Therapeutics, Inc.



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