NEW YORK, NY--(Marketwire -03/29/12)- The FDA is close to approving the first weight loss drug since Roche Holding AG's Xenical in 1999. Obesity treatment manufacturers may need to study the heart risks of their medicines before U.S. regulators weigh approval, Food and Drug Administration staff said in a report. The Paragon Report examines the outlook for companies in the Biotechnology Industry and provides equity research on VIVUS, Inc. (NASDAQ: VVUS - News) and Orexigen Therapeutics, Inc. (NASDAQ: OREX - News). Access to the full company reports can be found at: http://www.paragonreport.com/VVUS http://www.paragonreport.com/OREX
Vivus Inc., Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. are in a race to bring the first weight loss pill to the market in 13 years.
An advisory panel will hold a hearing on the drugs in Silver Spring, Maryland, starting March 28. The FDA is not required to follow the panel's recommendations. The potential approvals come 15 years after the fen-phen appetite-suppression drug combination had to be pulled from pharmacies when it was linked to heart valve abnormalities. The advisers will consider whether "obesity drugs without a theoretic risk or signal for" cardiovascular harm "should be required to rule out" some level of cardiovascular risk before approval, the FDA said in the report.
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Vivus' Qnexa is a controlled-release formulation that combines low doses of two older generic drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is also sold under the brand name Topamax by Johnson & Johnson to treat migraines and seizures.
In their most recent financial results, for the three months ended December 31, 2011, Orexigen reported a net loss of $4.3 million, or $0.09 per share, as compared to a net loss of $11.3 million, or $0.24 per share, for the fourth quarter of 2010. As of December 31, 2011, Orexigen had $101.7 million in cash and cash equivalents and an additional $45.8 million in marketable securities, for a total of $147.5 million.
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VIVUS, Inc. and Orexigen Therapeutics, Inc. Await FDA Approval for Weight Loss Drugs
