Athersys, Inc. (Nasdaq:ATHX) today announced that it has entered
into a manufacturing services agreement with Nikon CeLL innovation
Co., Ltd. (NCLi) for commercial production of its stem cell
therapy, MultiStem®, in Japan for ischemic stroke. NCLi is a
wholly-owned subsidiary of Nikon Corporation and provides a wide
range of process development and manufacturing services, from
pre-clinical to commercial manufacturing of cell and gene
therapies.
Based on the agreement, Athersys and NCLi will
engage in technology transfer activities at NCLi’s facility in
Japan, and NCLi will begin contract manufacturing support for
commercial development of the product in Japan. Athersys’
collaborator, HEALIOS K.K. (Healios), has an exclusive license to
develop and market MultiStem in Japan for ischemic stroke, and is
currently conducting its registrational clinical study, TREASURE,
in Japan.
Therapeutic treatment with MultiStem may extend
the stroke treatment window to 36 hours from the current three to
four and a half hours with existing standard of care, which would
enable many more stroke patients to receive treatment than under
the current standard of care and may also meaningfully enhance
patient recovery.
“We are excited about our new alliance with
Nikon CeLL innovation, focused on establishing the manufacturing
infrastructure that will enable us and Healios to achieve our goals
in Japan. Nikon brings important capabilities to the
partnership, including an extensive investment in facilities and
technology. We and Healios agree that this puts us both in a
strong position to achieve our goals,” commented Dr. Gil Van
Bokkelen, Chairman & CEO at Athersys. “With a successful
study outcome and subsequent product registration, Athersys’
MultiStem cell therapy would represent the first major advancement
in more than twenty years for the treatment of acute stroke.
We intend to be ready for success, and this alliance represents an
important step toward establishing the capabilities that will
enable us to take full advantage of this significant
opportunity.”
About Ischemic Stroke
Stroke represents an area where the clinical
need is particularly significant, since it is a leading cause of
death and serious disability worldwide, with a substantially
impaired quality of life for many stroke victims. Currently, there
are nearly 17 million people that suffer a stroke globally and, on
average, someone in the United States has a stroke every 40
seconds. 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
long-term or permanent disability due to neurological damage.
Unfortunately, current therapeutic options for ischemic stroke
victims are limited, since the only available therapies,
administration of the clot dissolving agent tPA, or “thrombolytic,”
or surgical intervention using mechanical reperfusion to remove the
clot, must be conducted 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
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 neurological,
cardiovascular, and inflammatory and immune disease areas, and has
several ongoing clinical trials evaluating this potential
regenerative medicine product. Athersys has forged strategic
partnerships and a broad network of collaborations to further
advance the MultiStem cell therapy toward commercialization.
More information is available at www.athersys.com.
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 regulatory
approvals and market acceptance of our product candidates and our
ability to generate revenues, including MultiStem for the treatment
of ischemic stroke, acute myocardial infarction, spinal cord injury
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: the
success of our collaboration with Healios and others, 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 possible inability to realize
commercially valuable discoveries in our collaborations with
pharmaceutical and other biotechnology companies; 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; our ability to raise additional capital;
results from our MultiStem ongoing and planned clinical trials,
including the MASTERS-2 Phase 3 clinical trial and the Healios
TREASURE clinical trial in Japan; the possibility of delays in,
adverse results of, and excessive costs of the development process;
our ability to successfully initiate and complete clinical trials
within the expected time frame or at all; 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.
ATHX-STR
Contact:
William (B.J.)
Lehmann
President and Chief Operating
Officer
Tel: (216) 431-9900bjlehmann@athersys.com
Karen Hunady Corporate CommunicationsTel: (216)
431-9900khunady@athersys.com
David Schull Russo Partners, LLCTel: (212)
845-4271 or (858)
717-2310David.schull@russopartnersllc.com
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