Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Consilient Health Ltd. for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in the UK and Ireland

SAN DIEGO, Dec. 8, 2016 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ:OREX) today announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Consilient Health Ltd. have executed a commercialization and distributorship agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in the UK and Ireland. Mysimba is approved by the European Medicines Agency, as an adjunct to a reduced-calorie diet and increased physical activity, 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). Founded in 2005, Consilient is one of the fastest growing pharmaceutical companies in the UK with sales and marketing teams dedicated to working with primary care prescribers and payers across the UK and Ireland.

"Consilient has a strong presence in primary care, notably in women's health and bone health, and we are pleased to work with them for the commercialization of Mysimba in the UK and Ireland," said Michael Narachi, CEO of Orexigen. "With this agreement, we continue to expand availability of Mysimba in Europe, where the drug is already approved, and have signed an agreement that will increase product revenue in 2017. We continue to accelerate the progress on our ex-U.S. commercial strategy by expanding the availability of Contrave® and Mysimba for patients and physicians with agreements that support the drug's commercialization in additional territories worldwide."

Orexigen's strategy outside the U.S. is to establish commercial and distribution partnerships in which Orexigen and the local partner share value equally. Under the terms of the agreement with Consilient, Consilient will be responsible for all commercialization activity and expenses. Orexigen will supply Mysimba tablets to Consilient for a transfer price and potential regulatory and commercial milestone payments. Consilient expects Mysimba to be available in the UK and Ireland in the second quarter of 2017.

Ahmed Al-Derzi, Chief Executive Officer of Consilient, said, "We are very excited to have the opportunity to bring Mysimba to patients in the UK and Ireland. Obesity is a significant and growing issue in our countries, and Mysimba is an important new therapy to help address the problem. The product fits well with our focus on bringing innovative solutions for unmet patient needs and leveraging our team's strong skills in successfully launching new prescription medicines."

Obesity and related comorbidities are a significant health problem in the UK and Ireland.  According to the World Health Organization, 28.1% of adults in the UK and 25.6% of adults in Ireland are obese.¹ The rate of obesity has more than doubled in the last 25 years, according to the UK Government Office for Science. The NHS estimates direct costs attributable to overweight and obesity in the UK are projected to reach £10 billion per year by 2050 and that wider costs to society and business are estimated to reach £49.9 billion per year.²

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 Consilient Health Ltd.
Consilient Health was established in 2005 and has its headquarters in Ireland.  The company is an independent, dynamic and rapidly growing pharmaceutical company with a successful portfolio in Women's Health, Bone Health and generic products. With operations in the UK, Ireland and the Nordics, Consilient Health delivers quality, reliability and value for all its customers. www.consilienthealth.com.

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 and became the most prescribed branded obesity medication in the United States in June 2015. 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

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 and timing of commercialization of Mysimba in the UK and Ireland; the potential for the sale of Mysimba in the UK and Ireland to increase product revenue in 2017; the potential to receive regulatory and commercial milestone payments from Consilient; 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 will not be successful, particularly in the U.S.; 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; additional analysis of the interim results or the final data from the terminated Light Study, including safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; our ability to retain ownership of Contrave and Mysimba and create value in certain markets outside of the United States; 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 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; the therapeutic and commercial value of Contrave; our ability to successfully acquire, develop and market additional product candidates or approved products; our ability to maintain sufficient capital to fund our operations for the foreseeable future; estimates of the capacity of manufacturing and other facilities to support Contrave; 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-Q filed with the Securities and Exchange Commission on November 7, 2016 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.

SOURCE Orexigen Therapeutics, Inc.

References:

1. WHO Global Health Observatory data repository http://apps.who.int/gho/data/view.main.2450A?lang=en. Accessed 6 Dec 2016.
2. Government Office for Science Tackling obesities: future choices – project report (2^nd ed.) 17 October 2007

Contacts:

Jason Keyes
Chief Financial Officer
Orexigen Therapeutics, Inc.
+1-858-875-8600
[email protected]

Julie Normart
BrewLife (Media Contact for Orexigen)
+1-415-946-1087
[email protected]

Ahmed Al- Derzi
Chief Executive Officer
Consilient Health Limited
+44 (0)203 751 1888

Louise Blakeborough
Chapter Five (Media Contact for Consilient Health Ltd)
+44 (0)7831 444789

SOURCE Orexigen Therapeutics, Inc.

Related Links

http://www.orexigen.com