What is Stem Cell: [StemCells] SCs for Acute Radiation Syndrome

Osiris Therapeutics Awarded Department of Defense Contract for
Prochymal(TM) Fully Valued at $224.7 Million
Jan 3, 2008

¶ First award granted under Osiris - Genzyme partnership is aimed at
protecting U.S. military from the lethal effects of acute radiation
syndrome

COLUMBIA, Md. — Osiris Therapeutics (Nasdaq:OSIR) announced today
that it has been awarded a $224.7 million contract, including
purchase options, from the United States Department of Defense (DoD)
to develop and stockpile Prochymal, an adult stem cell therapy, for
the repair of gastrointestinal injury resulting from radiation
exposure.

Under the terms of the contract, the DoD will provide funding to
Osiris for the development of Prochymal for acute radiation syndrome
(ARS) in two stages, with an initial amount of $4.2 million in 2008.
Upon Food and Drug Administration approval for ARS, the contract
provides for the purchase of up to 20,000 doses, at $10,000 per dose,
of Prochymal in four 5,000 dose increments. Prochymal was selected by
the DoD as part of an open and competitive solicitation with pre-
specified criteria that included safety and efficacy data,
manufacturing capacity, soundness of the development plan, and time
to final product delivery.

"We are honored that the Department of Defense has selected Prochymal
in this critical effort to better safeguard our armed forces against
the potentially horrendous effects of battlefield exposure to a
radiological weapon," said C. Randal Mills, Ph.D., President and
Chief Executive Officer of Osiris. "The contract also brings into
focus a substantial new market opportunity for Prochymal. We are
working diligently towards licensure of Prochymal for ARS and stand
ready to assist other sectors of the United States government and
allied nations in their emergency preparedness efforts."

"Prochymal's unique mechanism of action and strong clinical profile
make it very well suited to address the complicated injuries
associated with ARS," said Major General John Parker, MD, (Ret.),
former Commanding General responsible for countermeasure development
and acquisition, and member of Osiris' Medical Countermeasure
Advisory Board. "Currently, every scenario contemplating a
radiological emergency, both civilian and military, involves people
suffering from the life-threatening effects of ARS without effective
treatments. Today's decision by DoD sets in motion a sound plan to
change that, by expeditiously completing development of the first
effective therapy for ARS."

Osiris and Genzyme Corporation (Nasdaq:GENZ) recently announced an
agreement to jointly develop Prochymal for use by U.S. and allied
nations for emergency preparedness. The Department of Defense
decision to fund Prochymal marks the first award under this new
partnership.

"We are pleased to partner with Osiris in developing this innovative
cell therapy to treat the potentially lethal complications of ARS for
the U.S. military," said Henri A. Termeer, Chairman and Chief
Executive Officer of Genzyme Corporation. "With our combined first-in-
class technology and development expertise, Osiris and Genzyme have
the necessary resources to complete this assignment for the
Department of Defense and to work with other governmental
organizations committed to safeguarding our nation and its allies."

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Prochymal is currently in Phase III clinical trials for the
treatment of Graft vs. Host Disease and Crohn's Disease and a Phase
II trial for type 1 diabetes. Prochymal has also demonstrated
preliminary efficacy in the treatment of patients experiencing heart
attacks. Prochymal has demonstrated a strong safety profile in 7
previous Phase I and II trials and has shown the potential to reverse
cellular damage and improve survival in disease states similar to ARS.

"Prochymal represents a breakthrough in countermeasure development
for ARS," said Thomas J. MacVittie, Ph.D., Professor of Radiation
Oncology and Pathology at the University of Maryland and member of
the NIAID Medical Countermeasures and CDC Strategic National
Stockpile Radiation Working Groups. "Prochymal has demonstrated
therapeutic utility in humans repairing many of the major organ
systems affected by radiation injury. Where most approaches only
target a single component of ARS, Prochymal has the potential to
address the entire syndrome including both acute and delayed effects
in multiple organ systems." Dr. MacVittie also serves as a member of
Osiris' Medical Countermeasure Advisory Board.

About Acute Radiation Syndrome

Acute Radiation Syndrome (ARS) involves damage to DNA predominately
affecting the rapidly dividing cells of the gastrointestinal (GI)
tract, skin and the bone marrow. The clinical manifestation of ARS
can be divided into four distinct stages: prodrome, latency, manifest
illness, and recovery or death. Typically, the prodromal phase
consists of GI symptoms that include abdominal pain, nausea, vomiting
and diarrhea lasting 2 to 6 days. Depending on exposure, during the
latent phase there is a brief abatement of symptoms as the patient
appears to recover from the initial illness. However, within days to
weeks, a hematopoietic (blood-forming) crisis ensues as a consequence
of the depletion of both white blood cell and red blood cell
progenitors within the bone marrow. The manifest illness is
characterized by immunosuppression, fever and diarrhea. Victims can
die within days to several months following initial exposure.

About Prochymal

Prochymal is a highly purified formulation of mesenchymal stem cells
(MSCs) that are grown in culture, permitting large-scale production.
The MSCs utilized in Prochymal are isolated from the bone marrow of
healthy adult donors. Because the cells can be expanded, thousands of
doses can be produced from a single donation. Numerous studies have
demonstrated that the stem cells in Prochymal are able to facilitate
tissue repair through a number of mechanisms. Specifically, MSCs are
able to down-regulate severe inflammation, which is responsible for
much of the tissue destruction that occurs as a result of radiation
exposure. MSCs also work at the cellular level to rebuild damaged
tissue through the coordinated release of tissue specific growth
factors. Preliminary studies suggest that these characteristics are
able to abate many of the complications of ARS.

Prochymal offers several unique advantages as a countermeasure for
the treatment of ARS both for civilian and military populations.
These include:

-- Flexible Treatment Paradigm - Prochymal is intended for the
treatment of patients post-exposure, even in those who are already
exhibiting symptoms, eliminating the need for immediate
administration in a predefined treatment window. This approach has
the added benefit of not requiring biodosimetry.

-- Advanced Development Stage - Prochymal has demonstrated safety and
efficacy in 7 clinical trials, and has advanced into Phase III for
three indications, each of which has been granted FDA Fast Track
status. The product also has an established stability profile that
permits long-term storage.

-- Large scale manufacturing - Osiris has existing capacity at
multiple manufacturing sites to mass produce large quantities of
Prochymal under GMP conditions.

-- Multiple Applications - Exposure to a radiological weapon can
affect multiple organ systems, referred to as combined injury.
Because MSCs are normally responsible for the repair of tissue injury
in adults, Prochymal has the potential to address multiple aspects of
ARS, including combined injury.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a small
start-up to a diversified enterprise with more than 9,500 employees
in locations spanning the globe and 2006 revenues of $3.2 billion. In
2007, Genzyme was chosen to receive the National Medal of Technology,
the highest honor awarded by the President of the United States for
technological innovation. In 2006 and 2007, Genzyme was selected by
FORTUNE as one of the "100 Best Companies to Work for" in the United
States.

With many established products and services helping patients in
nearly 90 countries, Genzyme is a leader in the effort to develop and
apply the most advanced technologies in the life sciences. The
company's products and services are focused on rare inherited
disorders, kidney disease, orthopedics, cancer, transplant, and
diagnostic testing. Genzyme's commitment to innovation continues
today with a substantial development program focused on these fields,
as well as immune disease, infectious disease, and other areas of
unmet medical need.

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 being evaluated in Phase
III clinical trials for three indications, including acute and
steroid refractory Graft versus Host Disease and also Crohn's
disease, and is the only stem cell therapeutic currently designated
by FDA as both an Orphan Drug and Fast Track product. Osiris has also
partnered with Genzyme Corporation to develop Prochymal(TM) as a
medical countermeasure to nuclear terrorism and other radiological
emergencies. Prochymal is also being developed for the repair of
heart tissue following a heart attack and for the protection of
pancreatic islet cells in patients with type 1 diabetes. The
Company's pipeline of internally developed biologic drug candidates
under evaluation also includes Chondrogen(TM) for arthritis in the
knee. Osiris is a fully integrated company, having developed
capabilities in research, development, manufacturing, marketing and
distribution of stem cell products. 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 47
U.S. and 215 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 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 mesenchymal stem cells 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 Annual Report on Form 10-K filed with the United
States Securities and Exchange Commission. Risk factors relative to
the matters discussed in this press release also include risks of
adverse changes in U.S. government spending priorities; failure to
retain existing U.S. government contracts or to obtain option awards,
task orders, or funding under contracts; risks of contract
performance; risks of contract termination, either for default or for
the convenience of the U.S. government; adverse results of U.S.
government audits of our U.S. government contracts; and risks
associated with complex U.S. government procurement laws and
regulations. 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 or Genzyme Corp.
Bo Piela, 617-768-6579 or Media Contacts: Schwartz Communications
Stacey Holifield/Andrew Law 781-684-0770 Osiris@schwartz-pr.com

http://www.centredaily.com/business/technology/story/309068.html

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StemCells subscribers may also be interested in these sites:

Children's Neurobiological Solutions
http://www.CNSfoundation.org/

Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123

The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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