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Orexigen and Takeda Announce Multiple Contrave Data Presentations at the ObesityWeek Meeting in Atlanta
Date:11/11/2013

exigen 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 fails to comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling and retaining the appropriate patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese patients treated with Contrave does not adversely affect Contrave's benefit‐risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE data; the potential for the Light Study to cost more than what is projected; the potential for early termination of Orexigen's North American collaboration agreement with Takeda Pharmaceutical Company Limited; the costs and time required to complete additional clinical, non‐clinical or other requirements prior to any resubmission of the Contrave NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital to fund our operations through potential approval of Contrave in 2014; the development plan for Empatic; Orexigen's ability to enter into a collaborative partnership for Empatic on acceptable terms, if at all; and other risks described in Orexigen's filings with the Securities and Exchange Commissio
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SOURCE Orexigen Therapeutics, Inc.; Takeda Pharmaceuticals, U.S.A., Inc.
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