Osiris Therapeutics Receives Title of European Orphan Drug Designation for Prochymal®

COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris
Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company
developing and marketing products to treat medical conditions in
inflammatory, cardiovascular, orthopedic and wound healing markets,
announced today that the European Medicines Agency (EMA) has designated
Osiris as the Orphan Drug title holder for Prochymal® ).

The EU Commission adopted the decision to transfer the designation of
Prochymal (ex-vivo cultured adult human mesenchymal stem cells) as an
orphan medicinal product under Regulation (EC) No 141/2000 of the
European Parliament and of the Council. The Decision will appear in the
EU Community Register of Orphan Medicinal Products.

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.

In the EU, the Orphan Drug designation for Prochymal is for the
treatment of acute graft versus host disease (GvHD). Prochymal, a
first-in-class allogeneic stem cell therapy, has already received
approval in Canada and New Zealand for the treatment of acute GvHD in
children, and is currently available in seven other countries including
the United States under an Expanded Access Program (EAP). Recently, Swissmedic,
the Swiss agency responsible for the evaluation of drugs, notified
Osiris that Prochymal will be evaluated under its Rapid Authorization
Procedure upon submission of the marketing application.

Prochymal is the world’s first approved drug with a stem cell as its
active ingredient. Developed by Osiris Therapeutics, 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 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 Crohn’s disease and in a Phase 2 trial
for acute myocardial infarction.

Osiris Therapeutics, Inc., having developed the world’s 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 50 U.S. and 156 foreign patents.

Osiris, Prochymal, Chondrogen, 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)

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strategy for mesenchymal stem cells and biologic drug candidates and
marketed Biosurgery products (including Prochymal, Chondrogen, 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
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Osiris Therapeutics, Inc.Erica Elchin, 443-545-1834OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.