Navamedic ASA: Enters into partnership agreement with Orexigen Therapeutics for Nordic launch of Mysimba®

5/2/2017 9:15:57 AM

Oslo, May 2, 2017 – Navamedic ASA (OSE: NAVA), the Norwegian medtech and pharmaceutical products company, today announced it has entered into a five-year agreement with Orexigen Therapeutics Ireland, Ltd., the subsidiary of the American biopharmaceutical company Orexigen Therapeutics, Inc. (Nasdaq: OREX), for Nordic marketing and distribution of Mysimba®, a prescription pharmaceutical.

“We are very pleased to announce the agreement with Orexigen Therapeutics for distribution of the prescription anti-obesity pharmacutical Mysimba (naltrexone HCl/bupropion HCl prolonged release), in the Nordic countries, and to offer Nordic physicians a prescription alternative for treating obesity. Adult obesity is a significant public health challenge and a major risk factor for a number of chronic diseases. Mysimba is used in combination with a reduced-calorie diet and increased physical activity for patients who are overweight or struggling with obesity in the presence of one or more weight-related co-morbidities (e.g. type 2 diabetes, dyslipidaemia, or controlled hypertension). The treatment targets a significant unmet need within the Nordic market where 15-20 percent of the population are overweight or struggling with obesity. The product strengthens our pharmaceutical products portfolio, and we believe the partnership agreement with Orexigen opens up a significant market opportunity and revenue potential moving forward,” says Tom Rönnlund, Chief Executive Officer of Navamedic.

Mysimba® is a centrally acting anti-obesity product used in adjunct to diet and exercise for management of weight in obese (BMI of ≥30 kg/m2) and overweight (BMI ≥27 kg/m2) adults with weight-related complications, such as diabetes, abnormally high levels of fat in the blood, or high blood pressure. The product has a unique, dual-action mechanism, using naltrexone and bupropion, which act on two separate areas of the brain, the hunger center and the reward system, to reduce hunger and help control cravings

The medication is approved by the European Union / European Medicines Agency, and under the agreement, Navamedic will have exclusive distribution rights in the Nordic region. Navamedic expects to begin marketing the product during Q4 2017 for an initial period of five years, renewable for an additional five-year period, according to the terms of the Agreement. Orexigen will supply Mysimba tablets to Navamedic for a negotiated transfer price and upfront milestone payments at signing and first commercialization sales. Additional milestone payments will be based on future sales levels.
“The agreement is a compelling opportunity for Navamedic to expand its portfolio with an exciting brand within an area of medicine with significant potential. It is also in line with the stated strategy to continue to form solid partnerships and have inflow of new products,” says Rönnlund.

Navamedic will market Mysimba® as part of the diversified pharmaceutical and healthcare products portfolio under the terms of the distributor partnership signed in April 2017.

For further information, please contact:

Tom Rönnlund, CEO, Navamedic ASA
Telephone: +46 727 320 321


ABOUT NAVAMEDIC:
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. 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.