Athersys' MultiStem(R) Stem Cell Therapy Receives Orphan Drug Designation in Europe for Prevention of Graft-Versus-Host Disease

Athersys' MultiStem(R) Stem Cell Therapy Receives Orphan Drug Designation in
Europe for Prevention of Graft-Versus-Host Disease

European Orphan Designation Complements U.S. Orphan Designation for MultiStem
Cell Therapy for Treatment of Patients with Leukemia or Related Malignancies
Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

CLEVELAND, Dec. 17, 2013 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX)
announced today that the Committee for Orphan Medicinal Products of the
European Medicines Agency (EMA) has issued a positive opinion (EMA/OD/146/13)
for the Company's allogeneic, multipotent adult progenitor cell, or
MultiStem^® therapy, for the prevention of graft-versus-host disease (GvHD).
The Company is developing its MultiStem cell therapy as a GvHD prophylaxis in
patients undergoing allogeneic hematopoietic stem cell (HSC) transplant and is
currently preparing for a Phase II/III clinical study in the area. The
MultiStem therapy for the prevention of GvHD has also previously been granted
orphan drug designation by the U.S. Food and Drug Administration (FDA).

"We are pleased to have been granted the benefits of orphan drug designation
in Europe," said Dr. Manal Morsy, Head of Global Regulatory Affairs at
Athersys. "Together with our U.S. orphan designation for this indication, this
EMA designation has the potential to facilitate our development of MultiStem
therapy to help patients at risk of GvHD associated with HSC transplantation."


Patients with leukemia or other related malignancies are typically treated by
radiation and chemotherapy, which are administered to destroy cancerous cells,
but also substantially impair the blood forming and immune system of the
patient.These procedures are followed by a HSC transplant to reconstitute the
immune system to fight infection and any remaining malignancy.Patients
undergoing donor derived, or allogeneic, HSC transplants are at significant
risk for serious complications, including GvHD, which results when
transplanted immune cells attack various tissues and organs in the patient.
GvHD can be severe and life-threatening, with substantial impact on overall
treatment requirements and costs, as well as on the patient's quality of
life.Annually, there are estimated to be more than 25,000 allogeneic HSC
transplants in the developed countries.

Athersys has completed a Phase I clinical study of the administration of
MultiStem cells to certain patients having allogeneic HSC transplants. The
study demonstrated the safety of MultiStem therapy in this indication and
suggested that MultiStem may have a beneficial effect in reducing the
incidence and severity of GvHD, as well as providing other benefits. These
results build on the work of Athersys scientists and collaborators who have
demonstrated that MultiStem cells suppress undesired T-cell-mediated immune
responses that are an important factor in causing GvHD and support tissue
repair and regeneration, leading to a significant increase in survival in
preclinical models.

Currently, the Company is preparing for a Phase II/III clinical study in the
area.It has met with the FDA and received feedback regarding proposed plans
for the next phase of clinical development and is finalizing the study
design. Based on current plans, the Company is preparing to be ready to start
this study in 2014, but the initiation will depend on the progress in other
clinical trials and the achievement of certain business development and
financial objectives.

Orphan drug designation, which is intended to facilitate drug development,
provides substantial potential incentives to the sponsor, such as fee
reductions for agency meetings, study-design assistance, opportunities for
expedited product development, orphan grant access, tax incentives and market
exclusivity for the product upon regulatory approval (7 years for the U.S. and
up to 10 years for the EU).

About Athersys

Athersys is a clinical stage biotechnology company engaged in the discovery
and development of therapeutic product candidates designed to extend and
enhance the quality of human life. The Company is developing its MultiStem^®
cell therapy product, a patented, adult-derived "off-the-shelf" stem cell
product platform for disease indications in the cardiovascular, neurological,
inflammatory and immune disease areas. The Company currently has several
clinical stage programs involving MultiStem, including for treating
inflammatory bowel disease, ischemic stroke, damage caused by myocardial
infarction, and for the prevention of graft-versus-host disease. Athersys has
also developed a diverse portfolio that includes other technologies and
product development opportunities, and has forged strategic partnerships and
collaborations with leading pharmaceutical and biotechnology companies, as
well as world-renowned research institutions in the United States and Europe
to further develop its platform and products. More information is available at
www.athersys.com.

The Athersys, Inc. logo is available at:
http://www.globenewswire.com/newsroom/prs/?pkgid=4548

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. These forward-looking statements relate to, among other things,
the expected timetable for development of our product candidates, our growth
strategy, and our future financial performance, including our operations,
economic performance, financial condition, prospects, and other future events.
We have attempted to identify forward-looking statements by using such words
as "anticipates," "believes," "can," "continue," "could," "estimates,"
"expects," "intends," "may," "plans," "potential," "should," "suggest,"
"will," or other similar expressions. These forward-looking statements are
only predictions and are largely based on our current expectations. A number
of known and unknown risks, uncertainties, and other factors could affect the
accuracy of these statements. Some of the more significant known risks that we
face that could cause actual results to differ materially from those implied
by forward-looking statements are the risks and uncertainties inherent in the
process of discovering, developing, and commercializing products that are safe
and effective for use as human therapeutics, such as the uncertainty regarding
market acceptance of our product candidates and our ability to generate
revenues, including MultiStem for the treatment of inflammatory bowel disease,
acute myocardial infarction, stroke and other disease indications, including
lysosomal storage disorders, and the prevention of graft-versus-host disease.
These risks may cause our actual results, levels of activity, performance, or
achievements to differ materially from any future results, levels of activity,
performance, or achievements expressed or implied by these forward-looking
statements. Other important factors to consider in evaluating our
forward-looking statements include: our ability to raise additional capital;
final results from our MultiStem clinical trials; the possibility of delays
in, adverse results of, and excessive costs of the development process; our
ability to successfully initiate and complete clinical trials; changes in
external market factors; changes in our industry's overall performance;
changes in our business strategy; our ability to protect our intellectual
property portfolio; our possible inability to realize commercially valuable
discoveries in our collaborations with pharmaceutical and other biotechnology
companies; our ability to meet milestones under our collaboration agreements;
our collaborators' ability to continue to fulfill their obligations under the
terms of our collaboration agreements; the success of our efforts to enter
into new strategic partnerships and advance our programs; our possible
inability to execute our strategy due to changes in our industry or the
economy generally; changes in productivity and reliability of suppliers; and
the success of our competitors and the emergence of new competitors. You
should not place undue reliance on forward-looking statements contained in
this press release, and we undertake no obligation to publicly update
forward-looking statements, whether as a result of new information, future
events or otherwise.

CONTACT: William (B.J.) Lehmann, J.D.
         President and Chief Operating Officer
         Tel: (216) 431-9900
         bjlehmann@athersys.com
        
         Investor Relations:
         Lisa M. Wilson
         In-Site Communications
         Tel: (917) 543-9932
         lwilson@insitecony.com

company logo
 
Press spacebar to pause and continue. Press esc to stop.