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Orexigen® Therapeutics Reports Fourth Quarter and Year Ended December 31, 2010 Financial Results
Date:3/10/2011

>2010 Highlights

  • Contrave NDA filing accepted by U.S. Food and Drug Administration (FDA)
  • Contrave Phase 3 results published in LANCET and Obesity
  • Secured Contrave North American partnership agreement with Takeda Pharmaceuticals North America, Inc.
  • The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of a post-approval vs. pre-approval cardiovascular outcomes study (11 to 8) and in favor of Contrave approval (13 to 7); the first positive vote on a new obesity therapeutic since 1997.

"We made significant progress in 2010, and I want to thank my colleagues at Orexigen, our key consultants and our partner, Takeda, for their outstanding efforts", said Michael Narachi, president and CEO of Orexigen.  "Despite our progress last year, we received a Complete Response Letter from FDA requesting conduct of a pre-approval cardiovascular outcomes trial.  As a result we have consolidated our resources and will focus our efforts over the next few months to determine the best path forward for Contrave."

Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)

The Orexigen management team will host a teleconference and webcast to discuss the fourth quarter 2010 financial results and recent business highlights.  The live call may be accessed by phone by calling (866) 788-0543 (domestic) or (857) 350-1681 (international), participant code 73770341.  The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com, and will be archived for 14 days following the call.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product, Contrave®, has completed Phase 3 clinical trials and has received a Complete Res
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SOURCE Orexigen Therapeutics, Inc.
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Related medicine technology :

1. Orexigen® Therapeutics Announces FDA Acceptance of Contrave® New Drug Application for the Treatment of Obesity
2. Orexigen® Therapeutics Schedules August 5, 2010 Webcast Discussion of Financial Results for the Second Quarter Ended June 30, 2010
3. Orexigen® Therapeutics Announces Publication of COR-I Phase 3 Study of Contrave in Lancet
4. Orexigen® Therapeutics COR-BMOD Study Published in the Journal Obesity
5. Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
6. Orexigen® Therapeutics to Speak at Rodman & Renshaw Annual Global Investment Conference
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9. Orexigen® Therapeutics Investigational Drug Contrave® Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity
10. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
11. Orexigen® Therapeutics Schedules March 10, 2011 Webcast Discussion of Financial Results for the Fourth Quarter and Year Ended December 31, 2010
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