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December 9, 2010
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Chicago, IL – December 9, 2010 – Zacks.com Analyst Blog features: Orexigen Therapeutics Inc. (OREX), Arena Pharmaceuticals Inc. (ARNA), Vivus Inc. (VVUS), MoneyGram International Inc. (MGI) and Western Union Inc. (WU).
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Here are highlights from Wednesday’s Analyst Blog:
FDA Panel Backs OREX’s Contrave
Orexigen Therapeutics Inc. (OREX) received a boost when an advisory panel of the US Food and Drug Administration (FDA) voted in favor of approving its obesity drug, Contrave. Contrave, a combination therapy, aims at addressing the physiological and behavioral causes of obesity.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13 - 7 in favor of approving the drug and concluded that the potential benefits associated with the use of the drug outweighed the potential risks. The panel also voted 11 - 8 in favor of a study to evaluate cardiac risks associated with Contrave as a post-approval necessity.
A final response from the FDA regarding the approval of Contrave is expected early next year (target date: January 31, 2011). Even though the regulatory agency is not bound to follow the advice of its advisory committee, the recommendation of the panel is usually considered while deciding the fate of a candidate.
We remind investors that the New Drug Application (NDA), seeking to market the obesity candidate in the US, was submitted by Orexigen in March 2010. The substantial amount of evidence gathered through the Contrave Obesity Research (COR) clinical program formed the basis of the application. The COR program studied more than 4,500 patients.
The positive opinion for Orexigen’s obesity candidate is a welcome departure from the FDA’s refusal to approve Arena Pharmaceuticals Inc.'s (ARNA) obesity candidate lorcaserin and Vivus Inc.'s (VVUS) obesity candidate Qnexa in the present form because of safety concerns. Both rivals failed to get a positive opinion from the advisory panels. Subsequently, the FDA issued complete response letters to the companies.
MoneyGram Proved Innocent
On Tuesday, MoneyGram International Inc. (MGI) received a reversal of $16.5 million as the verdict that was passed against it in a patent-infringement lawsuit filed by Western Union Inc. (WU) in 2009 was proved invalid. The US Court of Appeals for the Federal Circuit in Washington ruled out the verdict that was passed by the lower court of Texas in 2009.
Previously, Western Union had charged MoneyGram of contravening certain patents related to money transfer through telephones and other sources that do not require written forms. In 2009, a federal jury in Texas had also penalized MoneyGram with a $16.5 million payment to Western Union.
However, MoneyGram appealed to the US Federal Court and yesterday’s ruling has made the 2009 verdict invalid, thereby saving the already loss-making money transfer company.
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