Athersys (NASDAQ:ATHX) is a bio-pharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. ATHX is developing MultiStem, a patented adult-derived “off-the-shelf” stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications. (www.athersys.com)
Updates from our posts: 10/29/09 and 11/6/09.
Pfizer Inc (NYSE:PFE) is buying the rights to a stem-cell therapy to treat inflammatory bowel disease from ATHX. PFE will pay ATHX $6 M initially and up to $105 M in the future.
The relatively small payment reflects that “it’s really early for cell therapy and there’s more research to be done,” said Ruth McKernan, chief scientific officer of Pfizer Regenerative Medicine, a unit created by the company about 18 months ago to develop treatments based on stem cells. ATHX’s cells, derived from human bone marrow; have not yet been tested in people with inflammatory bowel disease, a term that encompasses ulcerative colitis and Crohn’s disease. But the product, called MultiStem, is in early human testing as a treatment for heart attacks and for cancer patients receiving bone marrow transplants. PFE and ATHX envision the cells being infused into patients not to replace damaged tissue but rather to produce various proteins that would help existing tissues heal or prevent them from being damaged. Stem cells derived from adult tissues, like MultiStem, are less ethically controversial than stem cells from human embryos. But MultiStem has been dogged by scientific controversy (NY Times).
Reiterating, ATHX’s MultiStem is a biologic product that is manufactured from human stem cells obtained from adult bone marrow or other non-embryonic tissue sources. Unlike other cell types, MultiStem cells after isolation from a qualified donor may be expanded on a large scale for future clinical use and stored in frozen form until needed. Cells obtained from a single donor require no genetic modification and may be used to produce banks yielding hundreds of thousands to millions of doses of MultiStem – an amount far greater than other stem cell types. Each bank is extensively characterized to ensure product consistency and safety. This “master file” approach uses a single product manufacturing platform to achieve consistency in product manufacturing, characterization and validation while pursuing multiple distinct pre-clinical and clinical product portfolios within the MultiStem application.
Bottom Line: Athersys’s cells, which are derived from human bone marrow have yet to be tested in people with inflammatory bowel disease,
- The pharmaceutical industry faces a growing problem in the drug development process; obtaining access to validated drug targets in order to develop new therapies without infringing on patents that restrict the use of cloned and isolated gene sequences encoding the target,
- The doors have opened giving the sector a better investment focus and visibility … let’s hope it continues!