Company Profile
Orexigen® Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of central nervous system disorders, including obesity. Our lead combination product candidates targeted for obesity are Contrave®, which is in Phase III clinical trials, and Empatic™, which is in the later stages of Phase II clinical development.
Beyond obesity, Orexigen is developing drug combinations for use in schizophrenia and obsessive-compulsive disorder. In addition, we intend to explore development of other potential drug candidates in CNS-related disorders in the future.
Market Opportunity
Drugs that can offer sustained weight loss with a favorable side effect profile are critically needed to address the growing obesity epidemic and its serious impact on healthcare in the U.S. and other developed nations.
There is growing recognition in the medical community that obesity is a leading risk factor for diabetes, high blood pressure and high cholesterol, referred to collectively as metabolic syndrome.
In addition, obesity and its co-morbidities are believed to cause significant added cost to the health care system. In 2000, the Department of Health and Human Services (HHS) estimated the overall economic costs of obesity in the United States to be $117 billion. There continues to be a significant unmet need for more effective pharmacological interventions despite the growing obesity rate, increased public interest in the obesity epidemic and significant medical repercussions as well as economic costs associated with obesity.
Overcoming the Weight Loss Plateau
Our lead product candidates were developed based on research regarding regulation of appetite and energy expenditure in the brain. Our drug combinations are designed both to generate weight loss and to limit the effect of the compensating mechanisms in the brain that prevent extended long-term weight loss. This dual approach differentiates our drug candidates from approved weight loss drug therapies that utilize only a single active ingredient. While these monotherapeutic approaches have been shown to drive initial weight reduction, weight loss typically plateaus after several months of treatment. In addition, we are investigating the behavioral mechanisms that drive people to eat even when not hungry. Both of the Contrave constituents are already approved for addiction-related disorders, and we expect that together they may reduce food craving and the 'reward' people may experience when eating certain types of food.
Multi-layer Intellectual Property Strategy
We apply a comprehensive strategy to the protection of our intellectual property. We combine unique dosage strengths and titration regimens for Contrave and Empatic with novel, proprietary sustained release formulations that are designed to improve tolerability of the drugs. Our multiple layers of IP protection include:
- Composition of matter patents protecting the combination of specific generic drugs for therapeutic use (already issued for both Contrave and Empatic)
- Method-of-use patents protecting against combination use as treatment for obesity (pending for Contrave, issued for Empatic)
- Proprietary sustained release formulations and titration regimens (patents pending) further enhance our proprietary position