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Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Bruno Farmaceutici S.p.A. for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Italy

SAN DIEGO, March 27, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (OREX) today announced that its wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Bruno Farmaceutici S.p.A. (Bruno) have executed a distributorship agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Italy.  Mysimba is approved by the European Medicines Agency for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).  Bruno manufactures and markets pharmaceutical products including drugs for treatment of diabetes.

"Bruno Farmaceutici S.p.A. is an outstanding partner to bring Mysimba to the Italian market," said Mike Narachi, CEO of Orexigen.  "This agreement, our fourth partnership in Europe, brings us into another major European market.  As we continue to advance our ex-U.S. commercialization strategy, we now have partnerships in a total of 39 countries worldwide and strong alliance management capabilities to support our partners in bringing Contrave® and Mysimba to patients who struggle to lose weight."  

Under the terms of the agreement, Bruno will be responsible for all commercialization activity and expenses.  Orexigen will supply Mysimba to Bruno for a negotiated transfer price and upfront milestone payments at signing and first commercial sale.  Additional payments will be based on sales levels.  Bruno expects that Mysimba will be available for patients in Italy in the fourth quarter of this year.

Obesity and related comorbidities are a significant health problem in Italy, where over 40% of adults are overweight or struggle with obesity, according to the Organisation of Economic Co‑operation and Development (OECD)1.  The World Health Organization2 predicts that obesity rates will continue to climb in Italy.

About Bruno Farmaceutici S.p.A.
Bruno Farmaceutici S.p.A., based in Rome, Italy, is a privately owned pharmaceutical company that has a commercial presence in Diabetes, Cardiology and Endocrinology.  Bruno currently markets over 25 prescription products in the Italian market and also has active partnerships with MerckSerono, Alcon and Ferrer.

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. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).

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, 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 for and timing of commercialization of Mysimba by Bruno in  Italy; the expectation to progress with our ex-U.S. commercial alliances in 2017; and the potential for a second study to further evaluate cardiovascular outcomes of Mysimba. 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; 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 Annual Report on Form 10-K which we intend to file with the Securities and Exchange Commission on or about March 29, 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

1 European Association for the Study of Obesity; Obesity in Italy
http://easo.org/media-portal/country-spotlight/obesity-in-italy/.
Accessed March 21, 2017

2 World Health Organization; Nutrition, Physical Activity and Obesity Italy
http://www.euro.who.int/__data/assets/pdf_file/0018/243306/Italy-WHO-Country-Profile.pdf.
Accessed March 21, 2017

 

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