Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, 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-US 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 US 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. 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.
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 programme 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.