EU agency prepares to assess first stem cell drug

* EMEA draws up guidelines for approving stem cell therapies

* Unnamed European company plans marketing application

By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON, May 12 (BestGrowthStock) – 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 authorisation 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
towards 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 tumours.

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 finalised 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 (RQE.L: ) is about
to start the world’s first stroke trial using foetal stem cells,
while U.S.-based Geron (GERN.O: ) 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.

Stock Market Today

(Editing by Louise Heavens)

EU agency prepares to assess first stem cell drug