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October 11, 2005

Takeda Pharmaceutical Company Limited

Additional Indication of Blopress® for the Treatment of Chronic Heart Failure Approved in Japan

Osaka, Japan, October 11, 2005 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that the Ministry of Labor, Health and Welfare (MLHW) in Japan approved on October 11 the use of its angiotensin receptor blocker ("ARB"), BlopressR (candesartan cilexetil) of the strengths 2mg, 4mg and 8mg tablets for the treatment of Chronic Heart Failure (CHF). Blopress has become the first ARB in Japan with this indication.

Takeda submitted an application for additional indication of CHF in December 2001 based on the clinical data with Japanese patients, which had shown proven efficacy of Blopress for prevention of progress of CHF. The dosage and administration for CHF of Blopress approved this time is; starting dose of 4mg q.d. which can be increased upto the maximum dosage of 8mg q.d., for the patients with mild to moderate CHF, for whom the treatment with ACE-Inhibitors is not adequate.

CHF is a disease which affects a daily life of patients due to symptoms such as difficulty in breathing and shortness of breath on exertion, edema of limbs, and with the high incidence of the fatal cardiac dysrhythmia and sudden death. It is expected that Blopress contribute to provide additional treatment options for CHF and the QOL of the patients with this disease.

As for Europe and the U.S., based on the outcome study CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity), CHF indication was approved in Europe in November 2004, and in the US, the monotherapy for CHF (New York Heart Association Class II-IV and ejection fraction less than or equal to 40 percent) was approved in February 2005, followed by the approval of the concomitant therapy with ACE-Inhibitors in May 2005. Therefore, now Blopress has become the only ARB with approved indications of CHF in all of three regions of Japan, the US and Europe.

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Notes to editors
  • • Candesartan cilexetil was discovered and originally synthesized by Takeda Pharmaceutical Company Limited and it was jointly developed with AstraZeneca.
  • • Candesartan cilexetil is marketed by Takeda as Blopress®, Amias® and Kenzen®, and by AstraZeneca as Atacand® under the license from Takeda Pharmaceutical Company Limited.
  • • CHARM study was sponsored and conducted by AstraZeneca.
  • • *The MRP on this occasion covered all EU countries apart from France. The reference member state during this procedure was the UK. (* EU countries excluding France and prior to 2004 expansion. Belgium, Denmark, Germany, Greece, Spain, Ireland, Italy, Luxembourg, Netherlands, Austria, Portugal, Finland, Sweden, United Kingdom).

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