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AstraZeneca Gets New US Approval for Seroquel XR

Reuters
Friday, 16 Nov 2007 | 8:58 AM ET

AstraZeneca said on Friday that U.S. health regulators had approved Seroquel XR, an extended-release version of one of its top-selling drugs, as a maintenance treatment for adult schizophrenia patients.

Seroquel XR is a once-daily version of schizophrenia drug Seroquel, which racked up $3.42 billion of sales for AstraZeneca in 2006, making it the Anglo-Swedish drugmaker's second-biggest selling medicine behind ulcer pill Nexium.

Standard-version Seroquel could face cheap, generic competition over the coming years and AstraZeneca is looking to Seroquel XR as a way of mitigating any damage to its sales.

"It's life-cycle management," said Collins Stewart analyst Navid Malik. He did not think that the new approval would have a big impact on AstraZeneca or that Seroquel XR would protect the bulk of AstraZeneca's revenues from a generic Seroquel.

"Apart from the convenience factor (of only taking a drug once a day), I don't think there's a big difference (from standard Seroquel)," he said.

Seroquel XR was approved by the U.S. Food and Drug Administration in May for the acute treatment of schizophrenia in adults.

"Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for options for long-term treatment of schizophrenia to help reduce the risk of the recurrence of acute psychotic episodes," AstraZeneca said in a statement.

In a clinical trial supporting the approval, patients receiving Seroquel XR showed an 84 percent reduction in the risk of relapse compared with those on placebo. Results showed the estimated risk of relapse after six months was 14.3 percent in the Seroquel XR group versus 68.2 percent in the placebo group.

Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions.

It affects over 2 million American adults -- about one per cent of the population aged 18 and older, AstraZeneca said.

AstraZeneca shares were up 0.1 percent at 2,207 pence, outperforming a 0.3 percent fall on the DJ Stoxx European health index.

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