Athersys, Inc. (“Athersys”) (NASDAQ:ATHX) announced today that
Athersys and Chugai Pharmaceutical Co., Ltd. (“Chugai”) have ended
the license agreement between them for the exclusive development
and commercialization of MultiStem® cell therapy for ischemic
stroke in Japan. The parties were unable to reach an
agreement on the modification of the financial terms of the
agreement and on development strategy in Japan, in light of the
results from the Phase 2 clinical study. All rights will
revert to Athersys, and Athersys will retain the $10 million
license fee paid by Chugai.
“Athersys and Chugai have great respect for one
another, and share common values and a desire to develop and
advance innovative therapies that have the potential to address
substantial unmet medical needs,” said Gil Van Bokkelen, Chairman
and CEO of Athersys. “Ultimately, however, we were not able to find
common ground regarding the best way to advance the ischemic stroke
program working together, and we agreed that a termination would
better enable Athersys to pursue its envisioned development
approach.”
Additionally, Athersys announced today that it
has entered into a letter of intent with a Japanese company,
accompanied by a good faith payment, to collaborate on the
development and commercialization of MultiStem cell therapy for
several indications in Japan, including ischemic stroke.
Athersys is also in ongoing discussions with several companies
about collaborating on the development and commercialization of
MultiStem therapy in multiple areas, including ischemic stroke
outside of Japan. Partnership remains a key part of Athersys’
development strategy for MultiStem cell therapy.
Athersys remains enthusiastic about the
development of MultiStem cell therapy in Japan. Recent
approvals by the Japanese Pharmaceutical and Medical Devices Agency
(“PMDA”) under PMDA’s new framework for accelerated development and
commercialization of regenerative medicine therapies have confirmed
the significance and availability of this new regulatory pathway to
product approval, as well as the potential for contingent or even
full approval with evidence of safety and data that suggests a
clinical benefit in patients. “We believe that this new
regulatory framework represents an important opportunity for
MultiStem in the treatment of stroke and potentially other
indications with high unmet need in Japan,” commented Gil Van
Bokkelen. “We have already presented our initial thoughts
regarding the next phase of clinical development in Japan to the
PMDA and have received encouraging feedback. We intend to
pursue this pathway, work with Japanese partners where it makes
sense, and look forward to updating everyone on our further
progress.”
About Ischemic Stroke
Stroke represents an area where the clinical
need is particularly significant, since it represents a leading
cause of death and significantly lowers quality of life for stroke
patients. Currently, there are more than 15 million people that
suffer a stroke globally, and more than two million stroke victims
per year in the United States, Europe and Japan combined. Ischemic
strokes, which represent the most common form of stroke, are caused
by a blockage of blood flow in the brain that cuts off the supply
of oxygen and nutrients, and can result in tissue loss and
neurological damage, as well as long-term or permanent disability.
Unfortunately, current therapeutic options for ischemic stroke
victims are limited, as the only available therapy, a clot
dissolving agent, or “thrombolytic,” must be administered within
several hours of the occurrence of the stroke. As a consequence of
this limited time window, only a small percentage of stroke victims
are treated with the currently available therapy—most simply
receive supportive or “palliative” care. The long-term costs of
stroke are substantial, with many patients requiring extended
hospitalization, extended physical therapy or rehabilitation (for
those patients that are capable of entering such programs), and
many require long-term institutional or family care.
About MultiStem
MultiStem cell therapy is a patented
regenerative medicine product that has shown the ability to promote
tissue repair and healing in a variety of ways, such as through the
production of therapeutic factors produced in response to signals
of inflammation and tissue damage. MultiStem therapy’s
potential for multidimensional therapeutic impact distinguishes it
from traditional biopharmaceutical therapies focused on a single
mechanism of benefit. The product represents a unique
"off-the-shelf" stem cell product that can be manufactured in a
scalable manner, may be stored for years in frozen form, and is
administered without tissue matching or the need for immune
suppression. Based upon its efficacy profile, its novel mechanisms
of action, and a favorable and consistent safety profile
demonstrated in both preclinical and clinical settings, MultiStem
therapy could provide a meaningful benefit to patients, including
those suffering from serious diseases and conditions with unmet
medical need. Athersys has forged strategic partnerships and a
broad network of collaborations to develop MultiStem cell therapy
for a variety of indications, with an initial focus in the
neurological, cardiovascular and inflammatory and immune disorder
areas.
About Athersys, Inc.
Athersys is an international 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, initially for disease indications in the cardiovascular,
neurological, inflammatory and immune disease areas, and has
several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys has forged strategic
partnerships and collaborations with leading pharmaceutical and
biotechnology companies, as well as world-renowned research
institutions to further develop its platform and products. More
information is available at www.athersys.com.
Athersys 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 ischemic stroke,
acute myocardial infarction, and acute respiratory distress
syndrome and other disease indications, including 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 possible inability to
realize commercially valuable discoveries in our collaborations
with pharmaceutical and other biotechnology companies; the success
of our collaborations, including our ability to reach milestones
and receive milestone payments, and whether any products are
successfully developed and sold so that we earn royalty payments;
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 or collaborations
and advance our programs, including the ability to enter into a
definitive arrangement with the Japanese company for the
development and commercialization of MultiStem cell therapy in
Japan; our ability to raise additional capital; 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 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:
Athersys, Inc.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 432-2461
bjlehmann@athersys.com
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