AstraZeneca's Seroquel Issues

AstraZeneca (AZN - Analyst Report) sales reps may have been instructed to tell physicians that the company’s multibillion dollar antipsychotic, Seroquel, was not associated with the development of diabetes. This, according to court documents and reported by the Wall Street Journal, contradicts what a company doctor had previously suspected. AstraZeneca commented that their doctors’ initial analysis was not conclusive, and after a more comprehensive review, it was found that the drug did not cause diabetes.

The WSJ noted that a variety of documents, from unpublished clinical studies to court depositions, were unsealed by AstraZeneca as a result of numerous lawsuits brought by patients claiming adverse affects from treatment with Seroquel.

Seroquel, along with the company’s extended release formula (Seroquel XR), is used for the treatment of a variety of psychotic disorders and is the leading branded drug for the treatment of bipolar and schizophrenia. Seroquel/XR posted combined sales of $4.45 billion in 2008, an increase of 11% over 2007.

The performance of Seroquel has been one of AstraZeneca’s few bright spots as the company deals with increasing generic competition to a number of key products. Seroquel/XR was AstraZeneca’s 2nd biggest selling drug in 2008 (behind only Nexium).  

In an unrelated event, AstraZeneca announced today that it had received a Complete Response Letter (CRL) from the FDA for its application for Seroquel XR in the treatment of generalized anxiety disorder (GAD). The company did not disclose details of the letter only saying the FDA is asking for more information to support the application.

Today’s announcement comes only 2 days after the FDA informed the company that the applications for the treatment of GAD and major depressive disorder (MDD) would be reviewed by a panel of specialists on April 8, 2009.