Good news for AstraZeneca (AZN) once again! The company received US Food and Drug Administration (FDA) approval for Seroquel XR (quetiapine fumarate) as an add-on treatment to antidepressants in adults with Major Depressive Disorder (MDD). Seroquel XR is an extended-release version of the company’s currently marketed Seroquel, which is approved for the treatment of bipolar disorder and schizophrenia.The approval comes shortly after AstraZeneca’s announcement of a billion dollar deal with Targacept (TRGT) for the development of a depression drug. However, the company received a complete response letter (CRL) from FDA for Seroquel’s approval as a first-line treatment for MDD. The agency has asked the company to undertake a Risk Evaluation and Mitigation Strategy (REMS) for all approved indications of Seroquel. This requires a proper survey of patients to ensure their understanding of the potential risks of the drug. The company will continue its discussions with ...

Highlights include Pfizer Ltd. (PFE), Merck & Co. (MRK), AstraZeneca plc (AZN), Abbott Laboratories (ABT) and Johnson & Johnson (JNJ).

Patent expirations of big-selling drugs, otherwise known as "patent cliffs," have recently received a significant amount of attention as a result of a sizable number of impending patent expiration for blockbuster drugs between now and 2012.

Lipitor, Pfizer's (PFE) $12+ billion cholesterol drug, accounts for roughly 25% of the company's revenue and is scheduled to lose patent protection in late 2011. Besides Lipitor, Pfizer will also lose patent protection on Caduet, Geodon, Viagra, and Xalatan between now and the end of 2012.

Altogether, Pfizer has drugs with about $18 billion in sales (about 40% of expected 2009 revenues) that will lose patent protection over the next four years. Pfizer is attempting to address their patent cliffs through cost-cutting and new sources of revenue. In January 2009,

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AstraZeneca (AZN) 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 ...