AstraZeneca ‘hoping for Seroquel XR approval’

Following reported failures of a number of candidate pharmaceutical products, AstraZeneca is hoping the sustained release formulation of its schizophrenia medication Seroquel – Seroquel XR (quetiapine fumarate sustained release) will gain regulatory approval this week, it has been reported.

In March 2007, AstraZeneca announced positive clinical study data for the compound at the European Congress of Psychiatry in Madrid. The trial results indicated that the once-daily formulation of the compound can improve schizophrenia symptoms and potentially increase the time to psychiatric relapse.

Pharmaceutical industry analysts predict that the drug will be approved by the US Food and Drug Administration when it issues its ruling on May 17th 2007, Reuters states, with company sources expecting a positive effect on the firm.

“We believe these things can have a significant impact on our business,” chief executive David Brennan told the news agency.

He praised the performance of the company’s life-cycle management programmes while adding that AstraZeneca has shown the ability to add extra value to its existing pharmaceutical products.

The sustained release formulation of Seroquel was submitted for regulatory approval in the US and Europe during 2006, while global sales of the original formulation of the compound reached $3.4 billion (1.7 billion pounds) in 2006.