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AstraZeneca Submits sNDA for Seroquel XR

AstraZeneca Submits sNDA for Seroquel XR for the Treatment of Generalised Anxiety Disorder

A First for the Atypical Antipsychotic Class of Medicines

LONDON, May 8, 2008-AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Seroquel XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of generalised anxiety disorder (GAD), including maintenance of antianxiety effect. It is the first time approval has been sought for an atypical antipsychotic medicine in GAD.

The submission is based on a robust clinical development programme involving more than 3,000 patients. This week, at the 161stAnnual Meeting of the American Psychiatric Association (APA) in Washington, D.C., data from two of the studies (Studies 9 and 12) supporting the submission, were presented. In the data presented, significantly greater symptom improvements were seen in patients treated with Seroquel XR compared to those treated with placebo, in short-term and maintenance treatment, with safety and tolerability consistent with the known safety profile of quetiapine.

GAD, which affects approximately 6.8 million adults in the U.S., is characterised by persistent anxiety, exaggerated worry and tension. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least six months. Several classes of drugs have demonstrated efficacy in the treatment of GAD. Treatment typically includes selective-serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs); however, approximately 30 per cent of patients do not achieve an adequate response to short-term treatment. Benzodiazepines, commonly prescribed antianxiety medications, may be used for the rapid relief of anxiety symptoms, but long-term use of these agents is not generally recommended.

The GAD submission is based on four Phase III efficacy and safety studies. Three short-term, multicentre, double-blind, randomised, placebo-controlled studies (Studies 9, 10, and 11) compared the safety and efficacy of Seroquel XR at doses of 50 mg, 150 mg and 300 mg to placebo for eight weeks in outpatients with GAD. Active controls were also used in Study 10 (escitalopram 10 mg daily) and Study 11 (paroxetine 20 mg daily). These short-term studies used the Hamilton Rating Scale for Anxiety (HAM-A) as the primary assessment of anxiety symptoms.

Study 12 was a long-term, multicentre, randomised-withdrawal, parallel-group, placebo-controlled, Phase III study that comprised four phases: an enrollment period of up to 28 days, an open-label run-in treatment period of four to eight weeks, an open-label stabilisation treatment period of 12 to 18 weeks, and a randomised-withdrawal treatment period of up to 52 weeks. The Seroquel XR dose was flexible: 50 mg, 150 mg, or 300 mg once daily, based on the clinical judgment of the investigator. In this longer-term study, the primary assessment was time from randomisation to an anxiety event.

In 2007, Seroquel XR was approved in the U.S. for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. Seroquel XR is currently not approved for the treatment of bipolar disorder. In January 2008, AstraZeneca announced the submission of two separate sNDAs to the FDA for Seroquel XR to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder. In February 2008, AstraZeneca filed a sNDA for Seroquel XR to seek approval for the treatment of MDD as monotherapy, adjunct therapy, and maintenance therapy. The FDA has not completed its review of these submissions. Global sales of Seroquel in 2007 were $4,027 million – an increase of 15 per cent.


May 8, 2008

Seroquel Enquiries:
James Read +1 302 885 9944

Media Enquiries:
Steve Brown +44 207 304 5033 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Neil McCrae +44 207 304 5045 (24 hours)

Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Mina Blair +44 20 7304 5084 mob: +44 7718 581021
Karl Hard +44 207 304 5322 mob: +44 7789 654364

Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518

Notes To Editors
About Generalised Anxiety Disorder (GAD)
GAD is characterised by chronic anxiety, exaggerated worry, and tension, even when there is little or nothing to provoke it. People with GAD anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work.

People with GAD cannot seem to get rid of their concerns, even though they usually realise that their anxiety is more intense than the situation warrants. They cannot relax, startle easily, and have difficulty concentrating. Often they have trouble falling asleep or staying asleep. Physical symptoms that often accompany the anxiety include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, twitching, irritability, sweating, nausea, lightheadedness, having to go to the bathroom frequently, feeling out of breath, and hot flashes. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least six months.

In the U.S. GAD affects about 6.8 million adults, with women twice as likely to develop GAD as men. The disorder comes on gradually and can begin across the life cycle. GAD rarely occurs alone and is often accompanied by other anxiety disorders, depression, or substance abuse. Genetic factors are also thought to be involved.

HAM-A Scale
The HAM-A rating scale consists of 14 items and measures the severity of symptoms such as anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, restlessness, and other physical symptoms.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

Posted: May 2008

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