ASTRAZENECA GAINS JAPANESE APPROVAL FOR TWO MAJOR TREATMENTS - TWO MORE EXPECTED BEFORE YEAR END

All three products and the line extensions will be launched early next year in Japan, the world's second largest pharmaceuticals market.

The two line extensions are for:

So far, in Japan, Omepral® has been restricted to short term (up to eight weeks treatment) for gastric ulcer and reflux esophagitis and six weeks treatment for duodenal ulcer, at a dose of 20mg. The approval for long term maintenance therapy includes an additional 10mg tablet strength.

These approvals for Omepral® will allow Japanese patients to benefit from longer term PPI therapy, in a market that until now has been dominated by H2 receptor antagonists as the standard treatment for acid related disease. The approval is expected to generate significant sales growth for AstraZeneca. Supplementary New Drug Application (s J NDA) packages for approval of H pylori eradication and for an intravenous formulation of Omepral® are still under review at MHW, and an s J NDA package for treatment of gastritis is due to be filed during 2001.

The registration approval is for:

With a cluster of new product launches into new segments, AstraZeneca has assigned exclusive marketing rights for Seroquel® in Japan to Fujisawa Pharmaceutical Co., Ltd. Fujisawa's experience and field force coverage will be invaluable in ensuring a successful launch in Japan, which represents a significant growth opportunity in the anti-psychotic sector with atypical antipsychotics currently representing only 22 per cent of these sales in value terms.

The registrations for which AstraZeneca are expecting approval in Japan before the end of 2000 are:

Arimidex® is one of the first products developed through Japan's new "drug organisation" consultation system, and was approved in a record 13 months from NDA. Following the introduction of the ICH E5 guidelines allowing the use of clinical data generated overseas in Japanese regulatory submissions, a 'bridging study' was completed to show that there were no differences in the absorption, distribution or biochemical efficacy of Arimidex® between Japanese and Western subjects. Safety and efficacy were then shown to be comparable by recruiting Japanese patients directly into a global study protocol comparing vs tamoxifen, to supplement the earlier phase II studies which had already been successfully completed in Japan.

AstraZeneca is the No. 2 oncology company in Japan and generates around 44 per cent of local sales via a dedicated oncology sales force of around 300 medical representatives. Casodex® , the anti-androgen for the treatment of prostate cancer was launched in 1999, and has already become the leading anti-androgen in the Japanese market.

AstraZeneca will use the approval of Accolate® -- already approved in 73 countries worldwide and used by over 2m patients - to build its respiratory franchise in Japan.

Mr. Bruno Angelici, President of AstraZeneca KK, based in Osaka, said: "This is an exciting time for AstraZeneca in Japan with three of its major products -and significant line extensions for omeprazole - approved in a short space of time. These products provide a tremendous boost to our ambitions to join the top ten pharmaceutical companies in Japan and we look forward to more marketing approvals next year."

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