Orexigen 2Q14 Quick Take – Expresses confidence in Contrave receiving US approval and positive EU CHMP opinion - August 8, 2014

Yesterday morning, Orexigen provided its 2Q14 financial update, in which management expressed confidence in Contrave (bupropion/naltrexone) receiving both an approval in the US and a positive CHMP opinion in the EU. As a reminder, the PDUFA date of Contrave was delayed by three months to September 11, as more time was required for Orexigen and the FDA to reach agreement on a undisclosed post-marketing obligation. Orexigen stated that the two groups are making progress on this post-marketing obligation and have "had ongoing high level engagement with the FDA." As a result, management felt "[confident] we can reach agreement on the final details." Orexigen also discussed progress on Contrave's EU submission. Orexigen felt optimistic in its ability to address the two questions raised by CHMP in its Day 180 List of Outstanding Issues issued late last month: providing (i) a synthesis of Contrave's benefit-risk profile and (ii) additional information regarding third party suppliers' study materials for bupropion. Orexigen plans to respond to these questions in September (accounting for time to receive information from suppliers), and indicated that it is in the "final stage of discussion prior to a likely oral hearing." Orexigen expects to hear from CHMP in October either with an approval opinion, notice of an oral explanation, or additional questions. Meanwhile, Orexigen is working closely with its North America commercialization partner Takeda on preparing to potentially launch Contrave in the US this upcoming fall; as pointed out in Orexigen's 1Q14 call, Takeda plans to carry out the launch with 900 sales representatives (significantly larger than Vivus' 150 representatives and Eisai's 600). Takeda now also has fully developed messaging and medical information platforms. During Q&A, Orexigen also expressed continued interest in pursuing a diabetes indication for Contrave, as well as a fixed-dose combination with a DPP-4 inhibitor. Further plans and details on these fronts are to be developed after the approvals. Stay tuned for our full report on Orexigen's 2Q14 financial update.