Athersys and Chugai Enter License Agreement and Collaboration to Develop MultiStem(R) Cell Therapy for Ischemic Stroke in Japan
(Thomson Reuters ONE) -
Regenerative Medicine Partnership Focused on Development of Novel Stem Cell
Therapy
CLEVELAND and TOKYO, March 2, 2015 (GLOBE NEWSWIRE) -- Athersys, Inc.
(Nasdaq:ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4519)
have announced a partnership and license agreement to exclusively develop and
commercialize MultiStem(®) cell therapy for ischemic stroke in Japan. Ischemic
stroke represents a priority disease area in Japan, given the high healthcare
burden of the condition and the expected increase in incidence associated with
Japan's aging population.
Athersys' proprietary cell therapy product, MultiStem, is currently being
evaluated in a Phase 2 clinical study for ischemic stroke in the United States
and Europe, and Athersys has begun preparations for clinical development in
Japan, including engagement with the Japanese Health Authority. Chugai is a
leading research-based pharmaceutical company with strengths in biotechnology
products, and brings to the collaboration substantial expertise and experience
in late-stage development and commercialization in Japan.
"We are delighted to have concluded a license agreement with Athersys for the
development and marketing of MultiStem, a very innovative cell therapy under
clinical development," said President and Chief Operation Officer at Chugai,
Tatsuro Kosaka. "By combining Chugai's strong expertise in biological
pharmaceuticals, we hope to bring MultiStem to the Japanese healthcare system as
a new treatment modality during the critical phase of ischemic stroke."
"We are excited to be working with Chugai in this important area and look
forward to combining our respective capabilities and expertise to successfully
develop and commercialize MultiStem for the treatment of ischemic stroke in
Japan," said Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer at
Athersys. "We believe that Chugai represents an outstanding partner with strong
capabilities in all facets of the development, commercialization and marketing
of novel medicines in the Japanese healthcare market. Chugai has been a leader
in the development and introduction of innovative biologics and has successfully
established one of the top sales forces in the prescription drug field in Japan,
which we believe represents a key competitive advantage that can help both
companies maximize value. Athersys and Chugai are committed to working together
to establish a leadership position in the regenerative medicine cell therapy
area in Japan."
As part of the collaboration, Chugai will be responsible for the development and
commercialization of MultiStem for ischemic stroke in Japan, and Athersys will
have responsibility for product supply. Under the financial terms of the
agreement, Athersys will receive an up-front cash payment of $10 million from
Chugai and would receive additional payments as the program is further advanced.
Athersys is eligible to receive milestone payments from Chugai of up to $45
million upon the successful achievement of certain development and regulatory
milestones, and sales milestones of up to 17.5 billion Yen (approximately $150
million based on the current exchange rate). Athersys would also receive from
Chugai tiered, double-digit royalties on any net sales, as well as payments for
product supplied to Chugai.
In Athersys' ongoing Phase 2 clinical study, it is evaluating the administration
of MultiStem cell therapy to patients who have suffered an ischemic
stroke. Based on preclinical research to date, administration of MultiStem has
shown significant benefits through several mechanisms, including reduction of
inflammation and immune system modulation in the ischemic area, and the
protection and rescue of damaged or injured cells, including neuronal
tissue. Athersys is treating patients one to two days after the stroke has
occurred, in contrast to thrombolytic tPA treatment, which is limited to the
first three to four hours following the stroke. Preclinical studies have
demonstrated that administration of a single dose of MultiStem therapy, even one
week after a stroke, provides significant and durable improvements relative to
controls. Enrollment in Athersys' double-blind, placebo-controlled trial is
complete, and interim safety and initial efficacy results following the ninety-
day patient data are expected to be announced in April 2015, following analysis
and receipt of the unblinded clinical data.
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, since 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.
About Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical
companies with strengths in biotechnology products. Chugai, based in Tokyo,
specializes in prescription pharmaceuticals and is listed on the 1st section of
the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is
actively involved in R&D activities in Japan and abroad. Specifically, Chugai is
working to develop innovative products which may satisfy the unmet medical
needs, mainly focusing on the oncology area. In Japan, Chugai's research
facilities in Gotemba and Kamakura are collaborating to develop new
pharmaceuticals, and laboratories in Ukima are conducting research for
technology development for industrial production. Overseas, Chugai Pharmabody
Research based in Singapore is engaged in research focusing on the generation of
novel antibody drugs by utilizing Chugai's proprietary innovative antibody
engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged
in clinical development activities in the United States and Europe. The
consolidated revenue in 2014 of Chugai totaled 461.1 billion yen and the
operating income was 77.3 billion yen (IFRS Core basis).
Additional information is available on the internet at http://www.chugai-
pharm.co.jp/english.
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 acute respiratory distress
syndrome and other disease indications. 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 Chugai, 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 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 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: Athersys, Inc.
William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
Fax: (216) 432-2461
bjlehmann(at)athersys.com
Chugai Pharmaceutical Co., Ltd.
Corporate Communications Dept.
Media Relations Group
Tel: 81-(0)3-3273-0881
Fax: 81-(0)3-3281-6607
pr(at)chugai-pharm.co.jp
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Athersys, Inc. via GlobeNewswire
[HUG#1898331]
Unternehmensinformation / Kurzprofil:
Datum: 02.03.2015 - 09:00 Uhr
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