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EU agency prepares to assess first stem cell drug
Ben Hirschler, European Pharmaceuticals Correspondent
LONDON
Wed May 12, 2010 1:24pm Mon, May 10 2010LONDON (Reuters) - The first regenerative medicine based on stem cells could be filed for approval in Europe later this year, bringing the groundbreaking medical technology a step closer to reality.

The European Medicines Agency (EMEA) said on Wednesday it had been informed about the "intent of a European manufacturer to submit the first application for marketing authorization for a stem cell-based product."

Drugmakers typically send a letter of intent to the London-based watchdog four to six months before a formal application, a spokeswoman said, so this would imply a filing toward the end of 2010.

The EMEA declined to name the company involved.

In preparation for the first of a possible wave of applications, officials from the EMEA met this week with drug company officials, regulators from the United States and Japan, and academic scientists to discuss guidelines for approving such treatments.

Research into stem cells has increased dramatically in recent years and there are currently some 40 clinical trials underway in the European Union exploring the use of stem cells to regenerate lost or damaged tissues and tackle various cancers. The majority use adult mesenchymal stem cells.

Stem cells -- which are particularly flexible when taken from days-old embryos -- are the body's master cells and can potentially be used to repair the heart, spinal cord, liver, pancreas, eyes and other parts of the body.

But their use is controversial and involves risk -- notably the danger that foreign cells might be rejected or could proliferate uncontrollably, leading to tumors.

MANAGING RISKS

To address some of these issues, the EMEA has drafted a "reflection paper" on the process for approving stem cell-based therapies, which will be finalized by the end of 2010.

"Stem cells hold the promise of an unlimited source of cells for therapeutic applications to treat patients who have no or only unsatisfactory treatment options," said Christian Schneider, chairman of the agency's Committee for Advanced Therapies.

"However, these therapies bear certain risks, such as tumourgenicity and immunorejection, and hence need to be carefully regulated with the input from multi-disciplinary expertise."

For many investors, stem cells remain off the radar screen for now after early excitement about the science was followed by delays and disappointments in the clinic.

But companies pioneering the technology have not given up and a growing number of large pharmaceutical companies are also starting to dip their toes in the water.

Believers see a parallel between the evolution of stem cell treatment and monoclonal antibodies. Antibody technology was first developed in the 1970s but it is only recently that such drugs have become blockbusters.

Among listed companies, Britain's ReNeuron is about to start the world's first stroke trial using foetal stem cells, while U.S.-based Geron hopes to restart a study using embryonic cells to treat spinal cord injuries in the third quarter of 2010.

Any stem cell treatment filed with the EMEA later this year could, in theory, become commercially in 2011.

The agency's scientific committee has instructions to issue an opinion within 210 days of receiving an application, or 120 days in the case of an accelerated procedure, although this regulatory clock can be stopped if more information is needed.

http://www.reuters.com/article/idUSTRE64B4NA20100512