SYMBICORT TURBUHALER Approved for the Treatment of Adult Asthma in Japan

AstraZeneca today announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.

AstraZeneca and Astellas Pharma Inc signed an agreement to co-promote Symbicort Turbuhaler in August 2009. The product will be manufactured and developed by AstraZeneca and distributed and sold by Astellas, while promotion will be jointly carried out by both companies.

“The approval of Symbicort Turbuhaler in Japan will provide patients and physicians with a new treatment option for the approximately five million adults living with asthma in Japan,” said Bruno Angelici, Executive Vice President for International Sales and Marketing, AstraZeneca.  “We are pleased this addition will support our commitment to deliver new medicines in Asia/Japan, working with our long-term partner Astellas.”

AstraZeneca conducted eight pivotal studies in Japan to support the approval of Symbicort Turbuhaler.  These included four studies on formoterol (two healthy volunteer Phase I studies and two phase II efficacy studies), and four on Symbicort (two healthy volunteer Phase I studies and two phase III efficacy and safety studies).

-ENDS-

NOTES TO EDITORS:

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

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16 October 2009

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