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"Initiation of ZB-202 is an important milestone for our Empatic programand the final anticipated step before moving into Phase III development," saidGary Tollefson, M.D., Ph.D., Orexigen President and CEO. "Empatic continuesto be an important component of the Company's obesity program. Along withContrave(R), now in Phase III clinical trials, these product candidates bothhave the potential to target a large, distinct and complementary segmentwithin the obesity market."
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Orexigen is the only company currently developing two late-stage productcandidates to address the full spectrum of obesity ranging frommild-to-moderate and moderate-to-severe obesity. Obesity has become anational epidemic, with more than 70 million Americans classified as obese and300,000 deaths a year attributable to obesity, according to the Centers forDisease Control (CDC). Obesity is associated with a number of significantmedical conditions, including diabetes, hypertension, high cholesterol andcoronary artery disease, among others. Research has shown that obesity has agreater impact on the development of chronic conditions in the U.S. thanpoverty, nicotine or alcohol abuse. Obesity also places a significantfinancial burden on the economy with mortality and morbidity costs estimatedto exceed $100 billion annually.
Empatic combines zonisamide and bupropion, two existing drugs that havebeen independently approved by the U.S. Food and Drug Administration (FDA) totreat other central nervous system disorders. Orexigen has developed aproprietary sustained release (SR) formulation of zonisamide that hasdemonstrated a better tolerability profile than the legacy, immediate release(IR) formulation. These two drugs were selected based on their complementaryactivity in reducing appetite, increasing the body's burning of calories andsustaining weight loss.
The Company's other late-stage obesity product candidate, Contrave(R), isa combination of bupropion SR and naltrexone in a proprietary SR formulationthat also appears to result in improved tolerability compared to the legacynaltrexone IR formulation. Contrave currently is being studied in four PhaseIII clinical trials that are fully enrolled. The program continues onschedule with initial results anticipated in late 2008 or early 2009 and thefiling of a New Drug Application (NDA) with the FDA projected for late 2009.
Phase IIb Empatic Trial Details
ZB-202 is a randomized, double-blind, placebo-controlled trial involvingapproximately 720 generally healthy, nondiabetic obese patients at 20 sitesnationwide. The primary endpoint for this trial is percent change in bodyweight after 24 weeks of blinded therapy. Patients will be randomized to oneof six treatment groups including two of the Empatic doses associated withweight loss in the previous Phase IIb trial. The efficacy of Empatic will becompared against zonisamide monotherapy, bupropion monotherapy and placebo.Trial results are expected in the second half of 2009.
About Orexigen Therapeutics
Orexigen(R) Therapeutics, Inc. is a biopharmaceutical company focused onthe development of pharmaceutical product candidates for the treatment ofcentral nervous system disorders, including obesity. The Company's late-stageproduct candidates targeting o
