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Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
Date:11/12/2013

s of the Light Study excluding a prespecified level of risk of MACE; the potential for, and timing of, resubmission of a NDA for Contrave based on interim results of the Light Study; the possibility of resubmitting the Contrave NDA with the independent DMC report on the interim analysis and without the clinical study report for the interim analysis; the safety and effectiveness of Contrave; the potential for, and timing of, the accrual and adjudication of MACE in the Light Study; the probability of overall success of the Light Study; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the potential for the FDA to continue to honor the Special Protocol Assessment, or SPA; the potential to enter into a collaborative partnership for commercialization of Contrave outside of North America; the potential for Takeda to commercially launch Contrave in North America; the potential to enter into a collaborative partnership to fund Phase 3 development and, if approved, commercialization of Empatic™; the potential for the FDA to approve an NDA for Empatic without requiring data from a cardiovascular outcomes trial in addition to the data obtained from the Light Study; and the use of pharmacotherapy to treat obesity. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fai
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1. Orexigen and Takeda Announce Multiple Contrave Data Presentations at the ObesityWeek Meeting in Atlanta
2. Orexigen Therapeutics Enters Into Agreement with Sanofi to Manufacture Contrave for Territories Outside North America
3. A Balanced Risk-Benefit Profile Will Propel Orexigen/Takedas Contrave to Become the Most Widely Used Emerging Therapy for the Treatment of Obese and Overweight Patients
4. Orexigen Therapeutics Announces Date of Third Quarter 2013 Financial Results Conference Call and Upcoming Presentation at Credit Suisse Healthcare Conference
5. Orexigen Therapeutics to Present at the Bank of America Merrill Lynch Global Healthcare Conference
6. Orexigen Therapeutics Announces European Filing Strategy and Reports Business and Financial Results for the Second Quarter Ended June 30, 2013
7. Orexigen Therapeutics to Host Second Quarter 2013 Financial Results Conference Call and Webcast
8. Orexigen Therapeutics Announces Upcoming Clinical Data Presentations at American Diabetes Association Annual Scientific Meeting
9. Orexigen Therapeutics to Present at the Jefferies 2013 Global Healthcare Conference
10. Orexigen Therapeutics to Present at the UBS Global Healthcare Conference
11. Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012
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