Roche says that its anti-anemia drug CERA successfully completed four late-stage trials, laying the groundwork for a BLA and an eventual new drug that could garner more than a billion dollars in annual sales. Amgen has filed a lawsuit against Roche, claiming it infringed on six of its patents. But Roche insists that the litigation will not impede its marketing plans.
"The completion of the four CERA phase III maintenance studies is an important milestone in CERA's history, as we move forward with the Biologics License Application with expected filing with the US Food and Drug Administration in 2006," said Richard Hinson, vice president, operations, Hoffmann-La Roche. "CERA's unique ability to provide up to once-monthly dosing may potentially offer a convenient and efficacious treatment option for patients with anemia in all stages of chronic kidney disease."
- read this release [1] for more information
Links:
[1] http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/12-16-2005/0004235346&EDATE=