Healthcare Industry News: Osiris Therapeutics
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.
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 Osteocel® 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)
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements provide our current expectations or forecasts of future events. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding the following: our product development efforts; our clinical trials and anticipated regulatory requirements; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for MSCs and biologic drug candidates; our cash needs; patents and proprietary rights; ability of our potential products to treat disease; our plans for sales and marketing; our plans regarding our facilities; types of regulatory frameworks we expect will be applicable to our potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Registration Statement on Form S-1, File No: 333-134037, as filed with the United States Securities and Exchange Commission and declared effective on August 3, 2006. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.
Source: Osiris Therapeutics
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.