Healthcare Industry News:  GvHD 

Biopharmaceuticals Regulatory

 News Release - October 17, 2006

Osiris is Granted European Manufacturing Certification for PROCHYMAL(TM)

Approval Opens Europe for the Expansion of Phase III Trial

BALTIMORE--(HSMN NewsFeed)--Osiris Therapeutics, Inc. (NASDAQ:OSIR ) has received manufacturing authorization to distribute PROCHYMAL into Europe for its Phase III clinical trial. Distribution of product in Europe requires Good Manufacturing Practice certification, which was granted by a European auditor after a comprehensive review of product manufacturing and testing facilities. Good Manufacturing Practices or GMPs are the manufacturing standards that ensure drug products are consistently produced to quality standards appropriate for use in humans. GMPs have been established in over 100 countries, and compliance is a requirement to export pharmaceuticals between countries.

PROCHYMAL is being evaluated in a Phase III trial for the treatment of Graft vs. Host Disease or GvHD, a life threatening immunological reaction that occurs in about 50% of patients who receive donated bone marrow or a similar transplant. GvHD is a form of rejection that occurs when the donated bone marrow attacks the recipient's organs and is one of the leading causes of death in bone marrow transplant patients. There is currently no approved treatment for GHVD.

Approval to distribute PROCHYMAL in Europe marks the second expansion of the Phase III clinical program outside of the United States. Last week Osiris announced that it had received clearance from Health Canada to start enrolling patients in this landmark trial. Osiris began enrolling patients within the United States this summer.

"European participation is a significant part of our global Phase III strategy for PROCHYMAL," said Lode Debrabandere, Ph.D., Vice President and General Manager of Inflammatory Diseases at Osiris. "It is our intention to seek international marketing clearance for PROCHYMAL upon completion of this trial. GMP certification allows us to move forward with our plans for this global effort and serves to further validate the robustness of our proprietary stem cell manufacturing process."

The GMP certification was granted following a comprehensive assessment of the manufacturing process for PROCHYMAL. The on-site audit was conducted by an authorized person from the European Union or EU in accordance with EU regulations. The inspection included an examination of the company's quality systems, employee training, the manufacturing process and associated procedures, testing performed to ensure product quality and safety, and product labeling.

"To win market approval, we must demonstrate that our stem cell products are manufactured in a controlled fashion that allows for large scale production and strict adherence to quality standards," said Harry Carmitchel, Chief Operating Officer. "Receiving European GMP certification illustrates that we are well-positioned to move forward internationally with our late-stage commercialization efforts of PROCHYMAL."

PROCHYMAL is a preparation of mesenchymal stem cells specially formulated for intravenous infusion. The stem cells are obtained from the bone marrow of healthy adult donors. PROCHYMAL is currently being evaluated for the treatment GvHD and Crohn's Disease. The Phase III trial for GvHD is anticipated to be the final trial before the drug is submitted to FDA, Canadian and European regulatory agencies for full approval. PROCHYMAL has been granted Fast Track status by FDA. FDA established the Fast Track program to accelerate the development of drugs that show promise for treating life-threatening conditions. The drug has also been granted Orphan Drug status by FDA. Orphan Drug designation provides incentives to companies that develop drugs for underserved patient populations.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is a leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. Osiris currently markets and sells OsteocelŪ for regenerating bone in orthopedic indications. PROCHYMAL(TM) is in Phase 3 clinical trials and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product. The Company's pipeline of internally developed biologic drug candidates under evaluation also includes Chondrogen(TM) for regenerating cartilage in the knee, and Provacel(TM), for repairing heart tissue following a heart attack. Osiris is a fully integrated company, having developed stem cell capabilities in research and development, manufacturing, marketing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology in the United States and a number of foreign countries including 46 U.S. and 164 foreign patents owned or licensed. (OSIR-G)

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Source: Osiris Therapeutics

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