UPDATE 2-Dutch rebuff hits AstraZeneca's Seroquel XR in EU
* Dutch regulator rejects Seroquel XR in depression
* Astra refers application to European Medicines Agency
* Positive EU agency opinion could mean Q1 2010 approval
* No impact on 2009 earnings outlook
* Canada approves use of drug in major depression (Adds timeline for EU decision, sales, shares, U.S. background)
LONDON, May 29 (Reuters) - AstraZeneca's (AZN.L) goal of marketing its schizophrenia drug Seroquel XR as a treatment for major depression has been set back by a rejection from Dutch regulators, delaying its path to market in Europe.
The Netherlands Health Authority had been acting as the so-called reference member state under the European Union's mutual recognition process, whereby approval in one country clears the way for marketing authorisations across the bloc.
As a result of the rebuff AstraZeneca said on Friday it had referred its application to use the drug in major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use (CHMP), a scientific panel of the European Medicines Agency.
The European Medicines Agency approves drugs centrally, rather than by the mutual recognition process.
"A positive CHMP opinion would clear the way for approval in the first quarter of 2010," a company spokesman said, adding that the delay did not affect earnings guidance for 2009.
Shares in the Anglo-Swedish group were 0.1 percent higher by 0815 GMT, slightly underperforming a 0.4 percent gain in the European healthcare sector .SXDP.
Seroquel XR is currently approved for treating schizophrenia and bipolar disorder, but AstraZeneca believes it can also help patients with serious depression who are not appropriately managed on alternative antidepressants.
AstraZeneca said Canada had become the second country to approve it in MDD this month.
Seroquel is AstraZeneca's second biggest drug with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formula.
The Dutch decision to refuse approval for the medicine in MDD, because of a negative benefit-to-risk balance, comes after Seroquel XR won partial support from U.S. advisers as a treatment for the same condition last month. Continued...
