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Market Authorization from Health Canada Based on New Drug Submission
Mississauga, Canada - Intertek, a leading provider of regulatory, quality and safety services to a wide range of industries around the world, is pleased to have provided regulatory assistance to Osiris Therapeutics in obtaining the world’s first marketing authorization from Health Canada for a stem cell product, Prochymal®, used for the treatment of acute graft-vs-host disease (GvHD) in children.
Prochymal®, was authorized under Health Canada's Notice of Compliance with conditions pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favourable risk/benefit profile in clinical trials. Health Canada’s authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy.
“Intertek’s customers approach us with their market entry challenges and we strive to assist them in obtaining such successfully” states Dr. Ruud Overbeek, Vice President of Global, Health, Environmental, and Regulatory Services at Intertek. “Our programs support our customers’ comprehensive and complex requirements. We are pleased we could assist Osiris Therapeutics with their historic market approval.”
For further information, please contact:
Sales and Marketing Director
Chemicals & Pharmaceuticals
Telephone: +1 312 906 7716
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 30,000 people in more than 100 countries around the world. Visit www.intertek.com
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic areas and wound healing areas. Osiris currently markets Prochymal for refractory GvHD, Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. The company’s pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents. Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com.