Orexigen(R) CFO to Resign After Contrave Rejection

About a week after Orexigen^® announced cuts of about 40% of their workforce in the aftermath of the FDA's response letter requiring further studies bfore Contrave^® could be approved, Graham Cooper, senior vice president, Finance, CFO and treasurer has announced that he will resign.

Cooper, who has been with Orexigen^® since 2006, is leaving for personal reasons. He will remain in his current position until the year-end results are in and the annual report has been filed with the Securities and Exchange Commission. Jay Hagan, who is the senior vice president, Corporate Development and Strategy, will take over as the interim CFO.

Orexigen Therapeutics, Inc. (OREX) stock price closed the week at $3.29.

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Contrave Diet Pill Approval Denied by FDA

Orexigen, the developer of the weight loss pill, Contrave™, announced that the Federal Drug Administration has issued a response letter on Contrave™. In the letter, the FDA showed concern over the possible long term effects of the naltrexone HCl/bupropion HCl combination drug on the cardiovascular systems of obese/overweight people who would be the primary users of Contrave™.

The FDA is requiring that a long term study be done and were quoted "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."

Expectations are that this requirement will push out possible approval of Contrave™ several years. Orexigen's stock (OREX) began the day at $9.09 and after the disapproval ended the day at $2.50, down 72.5%.


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Contrave Diet Pill FDA Decision Expected on Monday

The Contrave(R)diet pill being developed by Orexigen, Inc. will discover it's fate tomorrow when the FDA decides whether or not to approve the drug. In December, an FDA advisory committee voted to recommend Contrave(R) for approval.

The panel was split and they also noted that some further research is needed which in their opinion could be done once approval has taken place. During the recent past, the FDA has denied approval for a couple of new drugs and recommended that another weight loss drug be removed from the market, so it is far from a sure thing that Contrave(R) will make it on this try.

The FDA could deny the application outright, but this is less likely due to the committee approval. They could decide that the research needs to be completed prior to approval, which would send Orexigen back to the drawing board setting up some new trials. Finally they could approve Contrave(R) and allow the needed research to be done afterwards. This would be the easier way for Orexigen, since once it's on the market, there will be thousands of users available to get the required data from.

Approval here may also pave the way for Orexigen's other weight loss drug, Empatic(TM), which like Contrave(R) is a combination of two drugs which are already sold on the market for other things.

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Weight Loss Pill CONTRAVE Gains Recommendation From FDA Panel

CONTRAVE has gained recommendation from the FDA's expert panel today by a vote of 13-7.

Orexigen's new entry into the weight loss arena gained the recommendation of the Food & Drug Administration's panel of experts this afternoon. Final approval will have to come from the FDA at a later time, but the FDA usually follows the lead of the panel.

More to come later.

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