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Orexigen cuts jobs

Orexigen Therapeutics has cut 40 per cent of its workforce following the recent refusal to approve obesity drug Contrave in the US

Orexigen Therapeutics has laid off 40 per cent of its workforce following the US Food and Drug Administration's (FDA) recent refusal to approve Contrave (naltrexone/bupropion), the obesity drug the company is developing with Takeda Pharmaceutical.

Orexigen said it was cutting 23 employees in the wake of the complete response letter it received on January 31 stating that the drug is not approvable until the company conducts an additional large-scale clinical study designed to measure cardiovascular effects.

The job cuts, which are expected to generate cost savings of about $5m a year, will result in a one-time charge for Orexigen of $2.6m related to employee termination costs.

Orexigen said it continues to believe in the potential of Contrave, which is its lead product candidate, and will discuss the drug's future with the FDA.

Meanwhile, the Obesity Society, a scientific society dedicated to the study of obesity, issued a statement taking the FDA to task for its handling of the Contrave marketing application and painting a pessimistic view of the drug's future.

"The economics of (the cardiovascular) trial make it extremely unlikely that it can be done, effectively ending hopes for approval, despite the earlier recommendation of the FDA's own advisory panel to approve the drug for use prior to a study," according to a statement from the Society.

Dr Jennifer Lovejoy, the Society's president, added: "The FDA seems to expect that any obesity medication must be as free of side effects as tap water. This is an unrealistic standard and one to which medications for other diseases are not held."

She continued, saying the Society "will be working with several other professional societies in the coming weeks to meet with FDA and Congressional leaders and discuss improvements to the process of reviewing obesity medications."

The FDA's decision on Contrave went against the recommendation of its Endocrinologic and Metabolic Drugs Advisory Committee, which voted at a meeting in December to recommend that the agency require a post-approval cardiovascular study of Contrave but determined that the current data is adequate for approval.

10th February 2011

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