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Orexigen Therapeutics Announces Commercialization and Distributorship Arrangement with Navamedic ASA for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Five Nordic Countries

SAN DIEGO, May 2, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ:OREX) today announced that its wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Navamedic AB, an affiliate of Navamedic ASA (Oslo:NAVA), have executed a distributorship agreement covering Denmark, Finland, Iceland, Norway and Sweden for Mysimba® (naltrexone HCl / bupropion HCl prolonged release).  Navamedic ASA manufactures and markets pharmaceutical products and medical technology to patients, hospitals and pharmacies in the Nordic, Benelux and Baltic markets.

"Navamedic ASA is strongly embedded across the Nordic countries and uniquely positioned to bring Mysimba to patients in Denmark, Finland, Norway, Sweden and Iceland," said Dr. Thomas Cannell, Chief Operating Officer and President of Global Commercial Products of Orexigen.  "We have now successfully entered into partnerships covering 44 countries outside the U.S., and this latest agreement marks our fifth partnership in Europe.  With global obesity rates on the rise, we are committed to leveraging our extensive alliance management capabilities to make Mysimba available to patients who struggle to lose weight in the Nordics and around the world."

Under the partnership, Navamedic will be responsible for all commercialization activity and expenses.  Orexigen will supply Mysimba tablets to Navamedic for a negotiated transfer price and upfront milestone payments at signing and first commercialization sales.  Additional payments will be based on sales levels.  Navamedic ASA estimates that Mysimba will be available to patients in the Nordic markets by the fourth quarter of this year.

Obesity and related comorbidities are a significant health problem across the Nordic countries and the World Health Organization (WHO) predicts that obesity rates will continue to climb in this region[i],[ii],[iii],[iv],[v].  According to data provided by the WHO, the percentage of the adult population struggling with obesity in these countries is: Denmark (19.3), Finland (20.4), Iceland (22.8), Norway (23.1), and Sweden (20.5).[vi]

About Navamedic ASA

Navamedic ASA is a Norwegian medtech and pharmaceutical products company, delivering products to patients, hospitals and pharmacies in the Nordic and Benelux markets.  The Group's Medtech business has developed and is currently introducing the next generation of digital urine meter Sippi®.  Navamedic's Pharma and Healthcare business is a distributor of products supplied by a number of pharmaceutical manufacturers.  Navamedic is listed on the Oslo Stock Exchange (ticker: NAVA).

About Mysimba

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 comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).  In the United States, the drug is approved as Contrave (naltrexone HCl / bupropion HCl extended release).

The exact neurochemical effects of Mysimba / Contrave leading to weight loss are not fully understood.  Mysimba / Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine.  Mysimba / Contrave is believed to work on two important areas of the brain – the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings.

Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Mysimba / Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Mysimba / Contrave or placebo.  In these studies, nearly half of patients taking Contrave lost 5% or more body weight and kept it off. (vs 23% of patients on placebo).  The most common adverse reactions (>5 percent) seen in patients taking Mysimba / Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

The clinical trial program also included a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study.  The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave.  A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity.  Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014.  In the European Union, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release).  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.  Further information about Orexigen can be found at www.orexigen.com and further information about Contrave can be found at www.contrave.com.

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 Mysimba to improve the quality of life for patients who are overweight or struggle with obesity; the potential to grow the availability of Mysimba with commercial launches in the Nordic countries in 2017; the potential for the growth of the obesity problem in the Nordic Countries; the potential for and timing of Navamedic's commercialization and marketing of Mysimba in the Nordic Countries; and the expectation to progress with our ex-U.S. commercial alliances in 2017.  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, particularly, with respect to Contrave, in the U.S. following the launch of the patient-focused marketing campaign; the Company's ability to obtain and maintain partnerships and marketing authorization globally; our ability to adequately inform consumers about Contrave; our ability to successfully commercialize Contrave with a specialty sales force in the United States; our ability to successfully complete the post-marketing requirement studies for Contrave; the capabilities and performance of various third parties on which we rely for a number of activities related to the manufacture, development and commercialization of Contrave/Mysimba; the therapeutic and commercial value of Contrave/Mysimba; competition in the global obesity market, particularly from existing and generic therapies; the Company's failure to successfully acquire, develop and market additional product candidates or approved products; the estimates of the capacity of manufacturing and the company's ability to secure additional manufacturing capabilities; our ability to obtain and maintain global intellectual property protection for Contrave and Mysimba; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; our ability to maintain sufficient capital to fund our operations for the foreseeable future; the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis' proposed generic product is not infringing each of the patents at issue; 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-K filed with the Securities and Exchange Commission on March 30, 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.

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

[i] World Health Organization; Nutrition, Physical Activity and Obesity Denmark http://www.euro.who.int/__data/assets/pdf_file/0006/243294/Denmark-Who-Country-Profile.pdf. Accessed March 21, 2017

[ii] World Health Organization; Nutrition, Physical Activity and Obesity Sweden http://www.euro.who.int/__data/assets/pdf_file/0003/243327/Sweden-WHO-Country-Profile.pdf. Accessed March 21, 2017

[iii] World Health Organization; Nutrition, Physical Activity and Obesity Finland http://www.euro.who.int/__data/assets/pdf_file/0008/243296/Finland-WHO-Country-Profile.pdf?ua=1. Accessed March 21, 2017

[iv] World Health Organization; Nutrition, Physical Activity and Obesity Norway http://www.euro.who.int/__data/assets/pdf_file/0019/243316/Norway-WHO-Country-Profile.pdf?ua=1. Accessed March 21, 2017

[v] World Health Organization; Nutrition, Physical Activity and Obesity Iceland http://www.euro.who.int/__data/assets/pdf_file/0015/243303/Iceland-WHO-Country-Profile.pdf?ua=1. Accessed March 21, 2017

[vi] Blundell J, E, Baker J, L, Boyland E, Blaak E, Charzewska J, de Henauw S, Frühbeck G, Gonzalez-Gross M, Hebebrand J, Holm L, Kriaucioniene V, Lissner L, Oppert J, -M, Schindler K, Silva A, M, Woodward E, Variations in the Prevalence of Obesity Among European Countries, and a Consideration of Possible Causes. Obes Facts 2017;10:25-37.  Accessed March 22, 2017, see WHO Figure 1.

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SOURCE Orexigen Therapeutics, Inc.