Healthcare Industry News:  Orencia 

Biopharmaceuticals FDA

 News Release - December 18, 2007

FDA Approves Celltrion to Manufacture ORENCIA(R) (abatacept)

INCHEON, South Korea, Dec. 18 (HSMN NewsFeed) -- Celltrion, Inc., a leading Korean biopharmaceutical company, announces that it has received approval from the U.S. Food and Drug Administration (FDA) to serve as a contract manufacturer to produce Orencia® (abatacept), a novel biologic agent for the treatment of rheumatoid arthritis, developed by Bristol-Myers Squibb Company (NYSE: BMY ). The Supplemental Biological License Application (sBLA) was submitted by Bristol-Myers Squibb Company to meet expected long-term demand for Orencia®.

Celltrion is the largest biopharmaceutical manufacturing facility in the Asia-Pacific region, and the only Asian large-scale cell-culture contract manufacturing facility which has successfully obtained approval from the U.S. FDA.

"We are pleased to continue our strategic business partnership with Bristol-Myers Squibb. Achieving sBLA approval from the FDA to manufacture Orencia® is an important milestone that reinforces our vision to become a fully integrated global biotechnology company," said Jung-Jin Seo, Chairman and Chief Executive Officer of Celltrion. "Celltrion is dedicated to working with our business partners to exceed their quality requirements while providing manufacturing value. It is our commitment to quality service that will attract other global biopharmaceutical companies to our manufacturing capabilities."

About Celltrion, Inc.

Celltrion, established in 2002, is a contract manufacturing organization with a headquarters in Incheon, South Korea. Celltrion, an emerging leader in the biopharmaceutical industry, is dedicated to providing high quality services to accelerate product development, while offering scalable manufacturing capabilities for our clients and business partners. Celltrion is also investing in research and development of its own products, as well as licensing from biopharmaceutical research companies throughout the world, in order to develop into a fully integrated biotechnology company. Further information can be found on our website

Source: Celltrion

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