Company news: AstraZeneca and Edelman

Share this article:

In a move designed to delay generic competition for one of its bestselling drugs, AstraZeneca filed a lawsuit against the FDA in a US district court regarding anti-psychotic Seroquel. AZ is seeking to prevent the agency from approving a generic version until December, when exclusivity ends on certain clinical data, or until a federal court can review the case. The suit, which comes after the FDA denied citizens petitions filed by the firm, involves a labeling disparity: the FDA is not requiring the generic to include the same hyperglycemia warnings that are printed on branded Seroquel, AZ said. The Seroquel franchise, which also includes Seroquel XR, grossed $5.8 billion in sales last year, up from $5.3 billion in 2010. The two drugs are part of a larger drug portfolio that is facing patent expiration and market erosion from drugs, like Pfizer's Lipitor, which have already gone off patent and post a threat to sales of AZ's Crestor. Seroquel XR, approved in 2009, is also sanctioned for add-on therapy to treat major depressive disorder, a line extension Seroquel did not have. Seroquel IR's patent expires March 26, vs. 2017 for the XR version.

Daniel J Edelman, the  holding company for Edelman and the Zeno Group, named Alan VanderMolen its first vice chairman. Vandermolen recently headed up Edelman's global practices and diversified insights businesses. He will oversee globalization of several DJE brands and of its sister agency, Zeno. VanderMolen joined Edelman in 2002 as president, Asia Pacific. He will report to CEO Richard Edelman.

Share this article:

Email Newsletters

More in Business Briefs

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Reckitt Benckiser wants out of pharma

The company plans to spin off its pharmaceutical unit.