Swissmedic Invokes Rapid Authorization Procedures for Prochymal Review
COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that it has been notified by Swissmedic, the Swiss agency responsible for the evaluation of drugs, that Prochymal® (remestemcel-L) will be evaluated under its Rapid Authorization Procedures. This designation, also known in Switzerland as Fast Track, typically cuts the evaluation period for promising new drugs in half.
Swissmedic approved the use of the Rapid Authorization Procedures following an initial review of summary clinical data for Prochymal used for the management of acute graft-versus-host disease (GvHD). Use of the Rapid Authorization Procedures is only permitted if the clinical data demonstrates a high potential for benefit for a severe, disabling or life-threatening disease, and where no alternative treatment option exists.
As a result of this decision, Osiris intendeds to promptly submit the full Common Technical Document to Swissmedic in the electronic or eCTD format to facilitate review. The Common Technical Document for Prochymal contains over 90,000 pages of data on the stem cell drug and is similar to the applications filed in Canada and New Zealand.
Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries, including the United States, under an Expanded Access Program.
GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.
About Prochymal (remestemcel-L)
Prochymal is the worlds first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics (OSIR), Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohns disease and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.
About Osiris Therapeutics
Osiris Therapeutics, Inc., having developed the worlds first approved stem cell drug, Prochymal, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. 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. (OSIR-G)
This press release contains forward-looking statements. 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 may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these 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 mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal®, ChondrogenTM, Grafix® and Ovation®); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and 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 Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. 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.
Osiris Therapeutics, Inc.
Erica Elchin, 443-545-1834
Source: Osiris Therapeutics, Inc.Copyright Business Wire 2012