Favourable Vote from FDA Advisory Committee on Seroquel Paediatric Supplemental New Drug Applications

Wednesday, 10 June 2009 On 10 June 2009, the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a review of the efficacy and safety of supplemental new drug applications (sNDAs) for SEROQUEL (quetiapine fumarate) proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age). The Advisory Committee voted as follows: Questions to the Advisory Committee Yes No Abstain 1. Has Seroquel been shown to be effective for the treatment of schizophrenia in pediatric patients ages 13-17? 17 1 0 2. Has Seroquel been shown to be acceptably safe for the treatment of schizophrenia in pediatric patients ages 13-17? 16 0 2 3. Has Seroquel been shown to be effective for the treatment of bipolar mania in pediatric patients ages 10-17? 17 0 1 4. Has Seroquel been shown to be acceptably safe for the treatment of bipolar mania in pediatric patients ages 10-17? 13 0 5 Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: “We are pleased that the committee found SEROQUEL to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with bipolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs.” The current approved indications for SEROQUEL are unchanged. SEROQUEL is not approved for use in patients under the age of 18 in any country. The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters. NOTES TO EDITORS: ABOUT SEROQUEL SEROQUEL was first approved in the US in 1997 and is currently approved for adults in the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; for the maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex; and for the treatment of schizophrenia. The safety of SEROQUEL has been evaluated in clinical trials with thousands of adult patients and continues to be reviewed by the FDA. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com CONTACTS: Media Enquiries UK: Neil McCrae +44 207 304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Media Enquiries US: Michele Meeker +1 302 885 6351 Kirsten Evraire +1 302 885 0435 Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 James Mead +44 20 7304 5084 mob: +44 7825 530018 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 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. 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