filed the lawsuit in response to an Abbreviated New Drug Application (ANDA) filed by Actavis, which sought to market and sell a generic version of the currently approved dose of Contrave tablets, prior to the expiration of U.
then conducted a study with about 9,000 patients to demonstrate the drug did not raise the risk of heart attacks.
Therapeutics Inc (OREX) shares declined 4.
15 December 2011 -- US investment bank Leerink Swann LLC has been picked sole book-runner for a proposed offering of units by Orexigen
Therapeutics Inc (NASDAQ:OREX), the obesity therapies developer said Wednesday.
In a conference call with stock analysts, Orexigen
chief executive Michael A.
The agreement calls for Takeda to make an up-front cash payment of $50 million to Orexigen
in return for the marketing fights for the drug in the United States, Mexico and Canada.
Disclosures: The study was funded by Orexigen
Therapeutics, which manufactures the naltrexone-bupropion combination under the trade name Contrave.
The trial is one of four studies that the drugs developer, Orexigen
Therapeutics, has sponsored in a bid to win approval from the U.
intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.
This license agreement with GSK complements the IP foundation of Contrave, providing us with additional product formulation options as we pursue regulatory approval and potential commercialization of Contrave," said Michael Narachi, President and Chief Executive Officer, Orexigen
In April, Orexigen
initiated enrollment in its first Phase III clinical trial for Contrave, a 56-week trial intended to evaluate Contrave's weight loss potential alone or when combined with intense diet, exercise and behavior modification.
Prominent firms in the combination drugs business include CombinatoRx, Pozen and Orexigen