News Release

Yamanouchi Pharmaceutical Co., Ltd.

Yamanouchi and Medtronic Sofamor Danek Conclude License Agreement on the Bone Morphogenetic Protein rhBMP -2

August 21, 2003

Yamanouchi Pharmaceutical Co., Ltd. (president: Toichi Takenaka; hereafter referred to as Yamanouchi) and Medtronic Sofamor Danek Co., Ltd. (president: Takaaki Tanaka; hereafter referred to as MSD), a Japanese subsidiary of Medtronic, Inc. of the United States (hereafter referred to as MDT), announced that the two companies agreed on granting the exclusive license to commercialize Yamanouchi's implantable recombinant human bone morphogenetic protein preparation (rhBMP-2; Yamanouchi's clinical trial code No.: YM484) in the field of orthopedic surgery in Japan and Asia to MSD. From now on, MSD will undertake the development, regulatory application, sales and sales promotion of rhBMP-2 in Japan. Yamanouchi will supply the raw material of rhBMP-2 to MSD and retain the right to co-promote rhBMP-2 together with MSD.

Until now, Yamanouchi has conducted clinical development of rhBMP-2 in Japan and has carried out evaluations to determine the indication and establish the commercialization policy. In Europe, a partnership jointly created by Yamanouchi's European subsidiary and a European subsidiary of Wyeth (New Jersey, USA) obtained approval for the product under the brand name of InductOsTM with an indication for open fracture of the tibia in September 2002. The exclusive promotion right was later granted to Medtronic Europe Sarl, a European subsidiary of MDT. Subsequent to reaching the European agreement, Yamanouchi and MDT have continued discussions on commercialization policy in Japan that would maximize rhBMP-2's product value and come to the above-mentioned agreement.

MDT is a world leader in the field of medical devices, including implantable products, and has professional knowledge and experience in the promotion and marketing of these products. In the United States, it is already marketing rhBMP-2 for the treatment of degenerative spinal disease. In Europe, it is preparing for the launch of InductOsTM.

rhBMP-2 was discovered by Wyeth, and co-developed by Wyeth and Yamanouchi. The protein is manufactured at the Wyeth biopharmaceutical facility in Andover, Mass. (USA).

[Company Profile]

Medtronic Sofamor Danek Co., Ltd. (
Incorporated: January, 1996
Headquarters: 7-20-1 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
Representative: Takaaki Tanaka, President
Description of
Importing and distributing of medical equipment

Medtronic, Inc. (
Incorporated: April, 1949
Headquarters: 710 Medtronic ParkwayMinneapolis, MN 55432-3576, USA
Representative: Arthur D. Collins, Jr, Chairman & CEO
Net sales: about 7.665 billion dollar (fiscal year ended April 2003)
Number of employees
about 29,000
Description of
Manufacturing, marketing and import/export, research and development, and providing technical information of medical equipment