Healthcare Industry News: Inflammatory Bowel Disease
News Release - November 14, 2011
Athersys Announces Recovery of All Rights to Cardiovascular Cell Therapy ProgramChange in Partner's Business and Financial Strategy Enables Athersys to Regain Rights in Key Area
CLEVELAND, Nov. 14, 2011 -- (Healthcare Sales & Marketing Network) -- Athersys, Inc. (Nasdaq:ATHX ), a leader in the emerging field of regenerative medicine, today announced the termination of its collaboration with Angiotech Pharmaceuticals, Inc. (Angiotech) to co-develop cell therapy in the cardiovascular field. In connection with the mutual termination, Athersys has regained all rights in its MultiStem(R) cardiovascular program, allowing it greater flexibility in clinical development and the opportunity to pursue new business collaborations within or including this important field.
"Angiotech has been an enthusiastic and committed partner in working with us to advance MultiStem into clinical development for treating damage from acute myocardial infarction (AMI). Subsequent to their completion of a recapitalization and balance sheet restructuring necessitated by unexpected liquidity and business challenges, Angiotech's management and Board of Directors has elected to focus in the immediate term on certain core medical device business efforts. Angiotech understands how important this program is to us, and by negotiating the return of full control of clinical development in AMI and other indications, it creates the opportunity for us to continue advancement of the programs and explore cardiovascular and more comprehensive collaborative development and commercialization arrangements with other potential partners," said William (B.J.) Lehmann, President and Chief Operating Officer of Athersys. "We want to thank Angiotech for its support over the years."
Athersys and Angiotech negotiated an agreement to terminate the collaboration and license agreements between the parties. As a result of the termination, Athersys has regained all rights for developing its stem cell technologies and products for cardiovascular disease indications, including AMI, congestive heart failure, chronic ischemia and peripheral vascular disease, and Angiotech will no longer have any license rights or options with respect to Athersys' technologies and products.
Through the termination, Angiotech will have no further funding obligations as relates to these programs. As a result, the termination would affect Athersys' future costs of development for ongoing cardiovascular programs, such as AMI, it also removes a significant encumbrance affecting Athersys' business development opportunities with other pharmaceutical, biotechnology and medical products companies.
In the case of a new AMI collaboration, Angiotech shall be entitled to a future payment from Athersys equal to a percentage of the upfront cash license fees Athersys receives from the third-party partner, but will not be entitled to receive any other payments or residual economic participation such as milestones, royalties and profit-sharing. Angiotech will retain its shares of Athersys common stock acquired through the collaboration and will cooperate with Athersys in the event Angiotech elects to pursue a disposition of its shares in the future.
Recently, Athersys announced the publication in Circulation Research of results from a Phase I clinical study that found that the delivery of MultiStem was safe and well tolerated in patients who had recently suffered an AMI. The data also suggested improved cardiovascular performance, particularly among patients with severely compromised heart function. Previously published preclinical studies have shown that administration of a single dose of MultiStem can convey therapeutic benefits through multiple distinct mechanisms, such as protecting and preserving at risk tissue in the heart, reducing inflammation and promoting revascularization over time. These studies also show improvement in cardiac function and increased capillary density in the heart in preclinical animal models of AMI.
"In the past months, we have been preparing to launch our Phase II AMI study. In light of the termination of the collaboration with Angiotech, we expect to review the study design, objectives and expected timelines with the intent of streamlining the study where possible and ensuring optimal alignment with our ongoing clinical development, business development and financial objectives. This is expected to delay our Phase II study initiation," commented Mr. Lehmann.
MultiStem is a patented and proprietary cell therapy product consisting of a special class of stem cells that are obtained from the bone marrow or other tissue sources of healthy, consenting adult donors, and which have the demonstrated ability to produce a range of factors, as well as form multiple cell types. MultiStem appears to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. Athersys believes that MultiStem represents a unique "off-the-shelf" stem cell product based on work that demonstrates the ability to deliver multiple mechanisms of therapeutic benefit, administration of the product without tissue matching or immunosuppression, and its capacity for large-scale production. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for Inflammatory Bowel Disease and with Angiotech to develop MultiStem in acute myocardial infarction and other cardiovascular indications.
Athersys is a clinical stage biopharmaceutical 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 MultiStem(R), 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, including for treating damage caused by myocardial infarction, bone marrow transplantation and oncology treatment support, ischemic stroke, and Inflammatory Bowel Disease. The Company also has developed a portfolio of other therapeutic programs, including orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE(R)). Athersys has forged several key strategic alliances 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.
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, 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; 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.
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