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Osiris Therapeutics Receives European Orphan Drug Designation for PROCHYMAL(TM).

BALTIMORE -- Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced today that it has received Orphan Drug designation from the European Medicines Agency (EMEA) for PROCHYMAL[TM], an adult stem cell product in Phase III pivotal trials for the treatment of acute Graft vs. Host Disease or GVHD. In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations. PROCHYMAL has already been granted both Orphan Drug and Fast Track status by the U.S. Food and Drug Administration, expediting the development of the stem cell treatment for acute GVHD.

Osiris has made significant progress in the development of PROCHYMAL including the following clinical and regulatory milestones:

* Initiated a Phase III clinical trial for GVHD

* Initiated a Phase III clinical trial for Crohn's Disease

* Completed five clinical trials, including three Phase II trials

* U.S. Food and Drug Administration Fast Track Status for GVHD

* U.S. Food and Drug Administration Fast Track Status for Crohn's Disease

* U.S. Food and Drug Administration Orphan Drug Designation for GVHD

* European Medicines Agency Orphan Drug Designation for GVHD

* European Good Manufacturing Practices Certification

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 in a double-blind, placebo controlled Phase III study for the treatment of GVHD. The ongoing Phase III study for GVHD is anticipated to be the final trial before the product is submitted to FDA, Canadian and European regulatory agencies for full approval. Following positive Phase II results, Osiris also received clearance to initiate a Phase III trial for PROCHYMAL for the treatment of Crohn's Disease.

"Receiving Orphan Drug designation for GVHD is a key step in our globalization strategy for PROCHYMAL," said Moya Daniels, Director of PROCHYMAL. "We appreciate the recognition from the EMEA and believe that PROCHYMAL has the potential to be the first treatment available for this devastating disease."

GVHD is a life threatening immune disorder that affects approximately 50% of patients who receive donated bone marrow transplants for the treatment of diseases such as leukemia. GVHD is a form of immune rejection between the newly transplanted bone marrow cells and the patient's own cells, leading to a cascade of syndromes often resulting in death. This new approach may potentially offer treatment options not only for patients with GVHD, but also other immune diseases such as Crohn's Disease and rheumatoid arthritis.

GVHD and Crohn's Disease are cell-mediated inflammatory processes that result in high levels of pro-inflammatory chemical signals called cytokines. These cytokines cause the unbalanced activation of certain immune cells that result in tissue damage. Delivered intravenously, PROCHYMAL is able to target areas of active inflammation. Laboratory data indicate that PROCHYMAL is able to down-regulate the production of pro-inflammatory cytokines, including tumor necrosis factor-alpha or TNF-alpha and interferon-gamma. It is believed that PROCHYMAL changes the course of inflammatory disease by altering the cytokine secretion profile of the dendritic and T-cell subsets, thereby resulting in a shift from a pro-inflammatory to an anti-inflammatory state and arresting disease progression. Furthermore, it is believed that PROCHYMAL facilitates the repair of previously damaged tissue through the secretion of growth factors that promote tissue regeneration and block programmed cell death or apoptosis.

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([R]) for regenerating bone in orthopedic indications. Prochymal[TM] is in Phase III 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 165 foreign patents owned or licensed. More information can be found on the company's website, www.Osiris.com. (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; the success of our product candidates in development; 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.
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Publication:Business Wire
Date:Jan 15, 2007
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