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December 7, 2010

Establishment of Olympus Biotech, and its Acquisition of Osteogenic Protein-1 (OP-1) Assets from US-based Stryker Biotech

Olympus Corporation ("Olympus," President: Tsuyoshi Kikukawa) is pleased to announce the establishment of a new company, Olympus Biotech Corporation in the United States(CEO: Hitoshi Mizuno). Agreement has been reached with Stryker Corporation concerning Olympus Biotech's acquisition from Stryker Biotech of a majority of assets in the Bone field pertaining to the development, manufacture and sale of Osteogenic Protein-1 (OP-1) Note 1.

Olympus has long been involved in R&D and business activities relating to various aspects of regenerative medicine. In one related field, it has signed a licensing agreement with Kaken Pharmaceutical Co., Ltd. concerning the development, manufacture and sale of basic fibroblast growth factor (bFGF) Note 2 for use in wound healing applications and is working to commercialize bFGF products for the European and North American markets. A subsidiary, Olympus Terumo Biomaterials Corp., has built a regenerative medicine business centering on biomaterials and has already brought a number of products to the orthopedic market, including the bone void filler "OSferion" and "Boneceram," and the artificial dermis "TERUDERMIS". Olympus' aim in establishing Olympus Biotech and acquiring the OP-1 assets is to develop its involvement in regenerative medicine business more globally and on a larger scale.

Stryker Biotech developed OP-1 (also known as BMP-7), which is a bone morphogenetic protein, and is building a global business based on this product. It has obtained a Humanitarian Device Exemption (HDE) Note 3 from the FDA, allowing it to be used in the United States for lumbar spine fusion and the treatment of long bone fractures.Note 4 Approval has been also obtained to sell OP-1 in Europe, Australia and Canada, and the product is already on sale. Like autogenous bone, OP-1 provides osteoinductivity and osteoconductivity. The market for bone graft for use in orthopedic field is expected to expand significantly.

Olympus Biotech, will acquire the assets of Stryker Biotech pertaining to the use of OP-1 for bone-related applications. By combining those assets with the existing biomaterial and regenerative medicine technologies of the Olympus Group, Olympus Biotech aims to optimize OP-1, expand sales of related products, and increase the range of uses. Olympus Biotech will also contribute to the further advancement of orthopedics and regenerative medicine while pursuing synergies with the bFGF business in Europe and North America, and with the existing biomaterials business of Olympus Terumo Biomaterials Corp.

Note 1 Osteogenic Protein 1 (OP-1): Also known as BMP-7, OP-1 is a bone morphogenetic protein (BMP) with osteoinductivity and osteoconductivity. With a development history of over 20 years, it has been used in 40,000 cases worldwide and is supported by numerous clinical and scientific papers. Osteoinductivity is the process whereby bone bridging occurs after the material is implanted, which is also provided by artificial bone. Osteoconductivity is a bone formation function, which occurs when the material is implanted in the lesion even without bone,like muscle. bone formation occurs, but artificial bone does not.
Note 2 Basic Fibroblast Growth Factor (bFGF): Growth Factor is a protein that controls the proliferation and differentiation of cells. Growth Factors are deeply involved in the formation of various types of tissue, including skin, blood vessels, bone and cartilage, and one of Growth Factors, bFGF is expected to have enormous potential in the field of regenerative medicine.
Note 3 Humanitarian Device Exemption (HDE): This is an application of FDA approval that allows products to be used for humanitarian purposes.
Note 4 Food and Drug Administration (FDA): The FDA has given HDE approval for OP-1 Implant and OP-1 Putty. OP-1 Implant is used to treat patients with recalcitrant long bone nonunions that are unsuitable for autograft or alternative treatments. OP-1 Putty is used in posterolateral lumbar spinal fusion procedures in cases in which autograft bone or marrow cannot be harvested.
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