Key Developments For Orexigen Therapeutics, Inc.
Orexigen Therapeutics, Inc. (OREX.O) (Consolidated Issue listed on NASDAQ Global Market)
Orexigen Therapeutics, Inc. Releases New Efficacy Data For Contrave
Orexigen Therapeutics, Inc. announced results from new intent to treat (ITT) analyses from the COR-I and COR-II Phase 3 trials of Contrave (naltrexone SR/bupropion SR), the first of two late stage Orexigen candidates for the treatment of obesity. These data expand on top-line results announced in July and complement findings from a panel discussion where the Company presented data on Contrave patients who completed 56 weeks of therapy. Results showed that, on an ITT basis, approximately 25-33% lost 10% or more of their body weight and 12-16% lost at least 15%; and obese patients on Contrave demonstrated significant improvements in important markers of cardiometabolic risk including waist circumference, HDL and triglycerides. Contrave Obesity Research (COR) Trial Design and Safety Profile All Phase 3 trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple measures of cardiometabolic risk, food cravings and eating control, as well as HbA1c in the COR Diabetes trial. Patients were randomized to receive either placebo or Contrave, BID, with a four week titration period. The Company is on track to submit a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.
Orexigen Therapeutics, Inc. Presents New Data Showing Weight Loss With Contrave Significantly Improves Important Markers Of Cardiometabolic Risk
Orexigen Therapeutics, Inc. announced the new data from the COR-I, COR-II and COR-Diabetes trials for Contrave (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity. These data were presented during a panel discussion at the 27th Annual Scientific Meeting of The Obesity Society. These new data show that after completing 56 weeks of therapy with Contrave32: Approximately 34-48% of patients lost at least 10% of their baseline body weight and approximately 17-23% lost at least 15%; Obese patients classified as higher risk for developing cardiovascular disease and diabetes demonstrated significant improvement in markers of cardiometabolic risk such as waist circumference, HDL, and triglycerides; Patients with type 2 diabetes taking Contrave who began the trial with a hemoglobin A1c (HbA1c) level greater than 8% saw a mean HbA1c reduction of 1.1%, which was highly statistically significant compared to placebo; Patients reported an increased ability to control their eating and resist food cravings; and There was no evidence of increased abuse liability.
Orexigen Therapeutics, Inc.'s Phase 2b Trial For Empatic Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus Comparators In Obese Patients
Orexigen Therapeutics, Inc. announced that its 24-week, Phase 2b trial for Empatic (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo. The Company plans to meet with the U.S. Food and Drug Administration (FDA) for an End of Phase 2 meeting to discuss these data with the goal of defining a Phase 3 plan for Empatic. Key top-line data from this study include the following: Patients completing 24 weeks of Empatic360 (bupropion SR 360 mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight, or 22 pounds, compared to 1.7% for placebo patients (p<0.001). Patients completing 24 weeks of Empatic360 (bupropion SR 360 mg/zonisamide SR 360 mg) therapy lost 9.9% of their baseline body weight, or 22 pounds, compared to 1.7% for placebo patients (p<0.001). Empatic patients experienced significant weight loss as early as their first post-baseline visit at week four. Importantly, Empatic patients continued to lose weight through the end of the trial period, with no evidence of a weight loss plateau. Improvements were observed in key markers of cardiometabolic risk such as waist circumference, triglycerides, fasting insulin and blood pressure.
Orexigen Therapeutics, Inc. Announces Full Exercise Of Overallotment Option By Underwriters
Orexigen Therapeutics, Inc. announced that its underwriters fully exercised their overallotment option to purchase an additional 1,500,000 shares of its common stock in connection with its previously announced public offering that priced on July 23, 2009. Including the overallotment shares purchased, the Company sold 11,500,000 shares at a public offering price of $7.50 per share, resulting in expected net proceeds to the company of approximately $81.6 million (after payment of the underwriting discounts and commissions and estimated expenses). Leerink Swann LLC acted as sole book-running manager for the offering. Lazard Capital Markets LLC, Canaccord Adams Inc., JMP Securities LLC and Natixis Bleichroeder Inc. acted as co-managers for the offering.
Orexigen Therapeutics, Inc. Prices Public Offering of Common Stock
Orexigen Therapeutics, Inc. announced that it has priced an underwritten public offering of 10,000,000 shares of its common stock at a price of $7.50 per share. Net proceeds, after estimated underwriting discounts and commissions and estimated expenses, will be approximately $70.9 million. Orexigen has granted the underwriter a 30-day option to purchase up to an additional 1,500,000 shares of common stock to cover overallotments, if any. The offering is expected to close on or about July 28, 2009. Leerink Swann LLC is acting as sole book-running manager for the offering.
