As the Contrave PDUFA date approaches, FierceBiotech has looked back at the milestones that brought Orexigen's (Nasdaq: OREX ) obesity drug to the forefront of the three-way battle with Arena and Vivus. From its promising trial results to partnerships to its breakthrough FDA expert panel approval, Contrave is near the end of the obesity drug gauntlet, with relatively few issues.
Date: December 7, 2010
Scoop: An FDA expert panel voted 13 to 7 in favor of approving Contrave. Its two competitors, marketed by Arena and Vivus, were both rejected by the panel earlier that year. The news bumped up Orexigen's stock price by 11%. Report
Date: September 2, 2010
Scoop: In a potential billion dollar deal, Orexigen handed over the North American marketing rights for Contrave to Takeda. The price? A $50 million upfront fee, followed by more than a billion dollars in milestone payments. The low initial price was typical for high-risk obesity drugs, which so far had received little FDA support. Report
Date: July 30, 2010
Scoop: Orexigen released positive results from its COR-I, Phase III Contrave study, which showed patients were two to three times more likely to lose 5% to 10% of their body weight while on the medication compared to a placebo. There were also significant results in waist circumference, insulin resistance, HDL cholesterol, triglycerides and hsCRP. However, only half of the patients finished the trial, an many placebo patients dropped out due to dissatisfaction with their weight loss. Report
Date: June 24, 2010
Scoop: The company received its panel review date, December 7, giving the company nearly two months between the panel review and its PDUFA date, January 31. Report
Date: April 13, 2010
Scoop: After releasing a round of positive results from a Phase III study, Orexigen backtracked and revised the results, noting they weren't as positive as originally reported. Only 50.5 percent of patients lost 5%or more of their body weight, compared to the 56.3% originally published. And 28.3% of patients lost more than 10% of their weight rather than 32.9%. Orexigen had filed its NDA with the FDA on March 31. Report
Date: July 20, 2009
Scoop: Contrave did well in three late-stage studies with over 4,500 total participants. The good news sparked a 32% rise in stock prices. Report
Date: January 9, 2009
Scoop: Orexigen released results for the first of four Phase III Contrave clinical trials, and the drug had met the co-primary and key secondary endpoints. Patients lost an average of 20.3 to 25 pounds compared to 11 to 16 pound for placebo recipients. And the company also stated there were no significant side effects, such as depression or worsening mean blood pressure. Report
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