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-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-
Date:7/20/2009

trave32 PBO (n=825) (n=456) (n=702) (n=456) (n=434) (n=267) Mean Weight Loss (%) 6.5%* 1.9% 6.4%* 1.2% 8.2%* 1.5% Mean Weight Loss (lbs) 14.0* 4.3 13.8* 2.8 17.5* 3.4 Greater than or equal to 5% weight loss (%) 55.6%* 17.5% 56.3%* 17.1% 75.8%* 21.7% # There was no statistical difference between patients re-randomized to Contrave32 or Contrave48; results not shown. + Primary endpoint ++ Pre-specified secondary endpoint; Contrave32 patients not achieving 5% weight loss double weighted because Contrave48 patients were excluded from efficacy analysis. * p<.001 COR-Diabetes (NB-304): A trial designed to assess the safety, tolerability and efficacy of Contrave32 versus placebo in 505 obese patients with type 2 diabetes. Measures of HbA1c and other measures of glycemic control were key secondary endpoints. This trial incorporated a typical diet and exercise regimen and was conducted at 52 US centers. Intent-To-Treat (N=424) Completers (N=275) 28 weeks 56 weeks 56 weeks Contrave32 PBO Contrave32 PBO Contrave32 PBO (n=265) (n=159) (n=265) (n=159) (n=175) (n=100) Mean Weight Loss (%) 5.2%* 2.0% 5.0%* 1.8% 5.9%* 2.2% Mean Weight Loss (lbs) 11.9* 4.7 11.6* 4.2 13.5* 5.1 Greater than or equal to 5% weight loss (%) 45.7%* 18.9% 44.5%* 18.9% 53.1%* 24.0% *p<.001

Across the entire COR program, seven serious adverse events were attributed by investigators as possibly related to Contrave treatment. These include cholecystitis
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SOURCE Orexigen Therapeutics, Inc.
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