Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Merck KGaA, Darmstadt, Germany for Contrave in Latin America

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.