Orexigen amends Contrave deal, reports sales
Orexigen Therapeutics Inc. (NASDAQ:OREX) gained $0.35 to $4.17 on Thursday after amending its Contrave naltrexone/ bupropion agreement with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and reporting U.S. sales of the obesity drug. Takeda had sent a dispute letter to Orexigen in May seeking to terminate the companies' collaboration based on an alleged material breach by Orexigen (see BioCentury Extra, May 13).
Orexigen will cover the total cost of the second cardiovascular outcomes trial (CVOT) for Contrave, which FDA required when it approved the drug last year. The estimated cost of the trial is $210 million; if the CVOT exceeds this figure, the companies will share additional costs equally. Under the original deal, Orexigen was responsible for the first $60 million in postapproval expenses, after which the partners were to share costs 50/50 for safety studies and 75/25 for other studies. ...