eye on the competition, post-merger..........
Wednesday April 25, 8:01 pm Eastern Time
Press Release
Nexell Loses Summary Judgment Against AmCell
Corporation
BURLINGAME, Calif.--(BW HealthWire)--AmCell Corporation won summary judgment
on Monday April 23, 2001, in the lawsuit filed in March of 2000 by Nexell Therapeutics Inc. (NEXL). The suit had claimed
clinical investigations and other activities conducted by AmCell infringe certain patents licensed to Nexell Therapeutics Inc.
In granting the summary judgment of non-infringement sought by AmCell, Judge McKelvie of the U.S. District Court in
Delaware noted it was a matter for AmCell and the FDA to decide on the course of activities leading to US regulatory
approval for the CliniMACS® system. Judge McKelvie reaffirmed that such activities, by US law, are exempt from claims of
infringement and rejected Nexell's arguments that there was infringement of the asserted patents. Judge McKelvie cited the
Cellpro (CPRO) decision in his opinion and noted the distinctly different nature of the matter before the court in this case.
Stefan Miltenyi, president and CEO of AmCell Corporation, said he was pleased by the outcome. He noted ``This was a
baseless suit brought for very improper business purposes. Among other things, it was intended to damage our clinical trials
program in the US which it has failed to do.'' He added: ``We are committed to bringing to US physicians the therapeutic
choices in cell transplantation available to doctors elsewhere in the world, and we are working closely with the transplant
community and the FDA to bring this about in the proper manner. There are many investigators developing innovative cell
therapy approaches in the US which take full advantage of the CliniMACS systems capabilities as they have been described
worldwide. Of course this requires FDA approval.''
``Many companies have failed in the field of cell therapy. But aside from our deep commitment to the field of stem cell therapies
we are also successful, developing both CD34 as well as our novel stem cell marker AC133/CD133, which has recently
entered clinical trials in Europe. We have a significant pipeline of innovative cell therapy products which will also be starting in
US clinical trials. We are here for the patients, their families and the physicians fighting the very serious diseases for which cell
therapy is being studied.''
Regarding the Nexell response to the ruling, Miltenyi stated: ``Suing us will not make Nexell's mounting financial problems
simply disappear.'' Miltenyi said Nexell's stated intent to ``work with the court and the FDA to ensure that the FDA's clinical
research guidelines are enforced'' is ridiculous. ``I don't think the Federal Court or the US FDA are going to need any help
from Nexell to carry out their roles,'' said Miltenyi. ``Both the court and the FDA have essentially told AmCell to proceed with
clinical trials toward approval. This has always been our plan. While the FDA has disapproved some clinical trials, it has been
primarily on technical grounds as is normal in the field. These trials are eligible for reconsideration once the investigator makes
the necessary changes to the protocol.''
AmCell Corporation developed and manufactures the CliniMACS line of cell separation systems used in cell therapy and
research worldwide. The CliniMACS system carries the CE Mark and has received regulatory approval for marketing in
Europe, Canada, several Asian nations and has approval pending in Australia. AmCell is involved in ongoing clinical trials in a
number of countries including Japan, Europe, and Israel as well the United States. Clinical research in the US is being
conducted in preparation for securing FDA marketing approval for the CliniMACS system. The CliniMACS system is available
worldwide for research use. It is available to US physicians for clinical use only under FDA-approved clinical investigations.
The CliniMACS system is distributed by Miltenyi Biotec worldwide and Kirin Pharmaceuticals in Asia. Miltenyi Biotec and
AmCell Corporation are privately held.
Contact:
AmCell Corporation
Stefan Miltenyi, 650/227-1100 |
