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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.