Orexigen Therapeutics Inc are the company responsible for the third and final of a trio of new “quick fix” weight-loss drugs to be presented to the U.S. regulators this year. They claim their pill can safely help patients lose unwanted body fat and are confident that no further studies related to heart conditions will be needed for their product after approval.
The biotech company is hopeful that its product, Contrave, when presented to the Food and Drug Administration, will not suffer the same rejection as the two previous applications from rival companies when they face the panel today.
The FDA may well push for further heart risk studies before or after approval but they will ask the advisors whether Orexigen needs to or not first. The FDA’s final verdict is expected by 31st January, 2011.
Shares in Orexigen have dropped by 36 percent this year amid fears by investors that the biotech company may well fail in their bid to launch Contrave, seeing as their rivals have also been rejected by the FDA already this year. But as obesity cases continue to soar, Orexigen are confident they can secure a large slice of the US market and as such have projected sales figures in excess of $1.2 billion by 2018.
Given that on current figures, two in three Americans are overweight or obese, many pharmaceutical companies have tried unsuccessfully to design a weight loss pill, but they have all been knocked back so far on the grounds of serious health risks, and other than dietary changes and regular exercise, very few options exist.
Back in October the FDA rejected Arena Pharmaceuticals Inc’s pill, after animal tests resulted in cancer, and Vivus Inc’s Qnexa pill needed more data on heart risks before any further consideration.
The FDA division responsible for weight loss drugs have been told to pay close attention to effects of new products on the heart, and deputy director Eric Colman said, “This is probably the more important issue we’ll be discussing today.”
Dawn Viveash, head of regulatory affairs for Orexigen, insists the company has been pragmatic in its approach after watching the fate of rival companies, and is “aware of the challenges” when trying to bring a new drug into the market place.
“The road has been long and hard both for individual drugs as well as for the class,” Viveash told the panel. Contrave’s “safety profile is well characterized … the known risks can be managed.”
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images: healthproductschoice.com, sxc.hu