Athersys, Inc., a leader in the emerging field of regenerative medicine, has terminated 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 cardiovascular programme, 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 programme 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 (BJ) 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 programmes. 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 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.