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Orexigen Therapeutics Announces European Filing Strategy and Reports Business and Financial Results for the Second Quarter Ended June 30, 2013
Date:8/6/2013

SAN DIEGO, Aug. 6, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced business and financial results for the second quarter ended June 30, 2013.

Orexigen also announced its plan to submit a Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) utilizing the centralized procedure. Orexigen has met with the European rapporteurs to discuss the filing strategy of the MAA. Both were supportive of the company's plan to submit the application in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.

"We are pleased with recent progress toward the Contrave MAA for Europe. From our interactions with multiple regulatory authorities in Europe, including with the assigned rapporteur and co-rapporteur, we believe European regulators recognize the need for new obesity therapeutics and support our plans for submission of the Contrave MAA," said Michael Narachi, Chief Executive Officer of Orexigen.

Narachi continued: "We remain focused on diligent execution of the Light Study, submission of the MAA within the next few months and resubmission of the NDA shortly after the interim analysis, which we continue to expect in the remaining months of 2013."

For the three months ended June 30, 2013, Orexigen reported a net loss of $18.2 million, or $0.19 per share, as compared to a net loss of $16.7 million, or $0.25 per share, for the second quarter of 2012.

Total operating expenses for the second quarter of 2013 were $19.1 million compared to $17.6 million for the second quarter of 2012. This overall increase in operating expenses reflects an increase in general and admini
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SOURCE Orexigen Therapeutics, Inc.
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