Cardiovascular Internal Medicine Department Professor Kim Duk-Kyung's team at Samsung Seoul Hospital of Sungkyunkwon University School of Medicine, a national research institute designated by the Korea's Ministry of Science and Technology, received approval from the Korea Food and Drug Administration (KFDA) in May, 2001- the first time such approval had been granted in Korea. Professor Kim's team had been conducting a Phase I clinical study of angiogenesis gene therapy using "VMDA-3601 injection" in 9 patients with ischemic leg disease. The team officially announced on August 26 that they had obtained the expected results.

Professor Kim Duk-Kyung, who led the study, explained the significance of this Phase I clinical study by saying, "We have passed the first barrier to establish a new therapy for patients suffering from severe ischemic leg disease, which was difficult to cure with existing therapies."

"VMDA-3601 injection" received approval from Korea's Ministry of Science and Technology and Ministry of Health and Welfare for use in clinical studies. It was jointly developed by Takara Bio Group's ViroMed Co., Ltd. (Takara Bio's consolidated subsidiary; established by Professor Kim Sunyoung of Seoul University, a director of our company) and Professor Kim Duk-Kyung et al. It was manufactured as a therapeutic agent by Dong-A Pharmaceutical Co., Ltd..

"VMDA-3601" has gathered the interest of Korea's medical sector as Korea's first clinical study of gene therapy. Since its safety has been demonstrated, a Phase II clinical study shall commence in the second half of this year to demonstrate its efficacy.

· Drug's safety verified through Phase I study
The clinical study process adopted 3 doses (2 mg, 4 mg, 8 mg) which were administered to a total of 9 subjects (3 for each dose) at week 0 and week 4. The subjects were observed for 9 months to evaluate the safety and efficacy. As a result, no adverse drug reactions related to the drug were observed in any of the patients, demonstrating that the Phase I study was a success.
As for the efficacy, new blood vessels were formed in the legs of 7 out of the 9 patients; among the 6 patients who had ulcers before administration, ulcers of 2 were completely cured, and 2 significantly improved; and pain was reduced in 7 patients of the 8 who had severe pain before administration.
Among the 7 patients who were considered to require amputation of the limb before administration, the conditions of 3 patients were reversed- no longer requiring amputation- and amputation surgeries of the remaining 4 patients were postponed.
However, since these results were observed in a small number of patients, the efficacy must be demonstrated in a larger-scale clinical study.

· Angiogenesis therapy
"Angiogenesis therapy" creates new blood vessels without surgery to replace old clogged vessels by administration of an angiogenesis gene.
VMDA-3601 is a therapeutic agent that incorporates VEGF165 (Vascular Endothelial Growth Factor), a gene regulating creation of a protein in blood vessel inner wall growth, into a gene expression vector. By injecting VMDA-3601 into the patient's leg muscle, VEGF165 protein is produced in muscle cells. As a result, many blood vessels are newly formed, creating a bypass path around the clogged blood vessels, thus smoothing the blood flow.
Previously, exacerbation of diabetic retinopathy, exacerbation of rheumatoid arthritis, acceleration of cancer cell metastasis in cancer patients, and other complications were predicted to occur as adverse effects in VEGF gene therapy. However, these complications were not observed in this clinical study.

· Future prospects
Since this clinical study verified the safety of the gene therapy drug VMDA-3601 to be superior, the research team will conduct a Phase II clinical study in patients with Buerger's disease from the second half of 2003 to verify its efficacy as a therapeutic agent.

About Takara Bio Inc.
Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin^® reagent, which is a world-standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy, and agricultural biotechnology; and is committed preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, the Company aims to extend its reach around the world. More information is available at http://www.takara-bio.com.

For more information:
Corporate Communications
Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp

This article is translated from press release in Japanese for your convenience.

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