CAMBRIDGE, Mass., Oct. 10 /PRNewswire-FirstCall/-- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced The Technical Board of Appeals
of the European Patent Office ("EPO") invalidated European Patent No. 0 505
500 owned by Applied Research Systems ARS Holdings, N.V., a wholly owned
subsidiary of Serono International S.A. ("Serono"). The Technical Board of
Appeals ruled that Serono's claims failed for lack of enablement.
In February 2003, Serono brought suit against TKT in the District Court at
The Hague in the Netherlands claiming that TKT's activities relating to
Replagal(TM) (agalsidase alfa) infringe European Patent No. 0 505 500. The
District Court proceedings at The Hague presently are stayed pending the
outcome of this appeal by Serono. TKT will move to dismiss this case, and
expects to prevail promptly.
"We are pleased that the EPO has entered final judgment against this
patent. TKT has long maintained that Serono did not play an inventive role in
gene activation, and this ruling vindicates TKT's position," said Mary S.
Consalvi, Vice President and Chief Intellectual Property Counsel of TKT.
About Replagal(TM)
Replagal is a fully human alpha-galactosidase A protein, produced using
TKT's gene activation technology, intended for the long-term treatment of
Fabry disease. It replaces the deficient alpha-galactosidase A with active
enzyme to halt or reverse the disease progression. Since August 2001,
Replagal has been approved for commercial use in 27 countries, including the
15 countries of the European Union. In the United States, Replagal is an
investigational product.
About TKT
TKT is a biopharmaceutical company developing therapeutics for the
treatment of rare genetic diseases caused by protein deficiencies. The company
currently markets one product, Replagal(TM) (agalsidase alfa) for the
treatment of Fabry disease in the European Union and certain other countries.
TKT is headquartered in Cambridge, Massachusetts and has a majority-owned
subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European
sales and marketing activities of Replagal. Additional information on TKT is
available on the company's website at http://www.tktx.com.
This press release contains forward-looking statements regarding the
validity of a certain patent owned by Serono and the possible outcomes of
patent litigation between the company and Serono involving Replagal and
statements containing the words "believes," "anticipates," "plans," "expects,"
"estimates," "intends," "should," "could," "will," "may," and similar
expressions. There are a number of important factors that could cause the
company's actual results to differ materially from those indicated by such
forward-looking statements, including: whether Serono's patent will ultimately
be determined to be invalid and whether Serono will be successful in asserting
the patent at issue against TKT, and other factors set forth under the caption
"Certain Factors That Affect Future Results" in the company's Quarterly Report
on Form 10-Q for the quarter ended June 30, 2003, which is on file with the
Securities and Exchange Commission and are incorporated herein by reference.
While the company may elect to update forward-looking statements at some point
in the future, the company specifically disclaims any obligation to do so,
even if its expectations change.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
CONTACT:
Daniella Lutz
Corporate Communications Specialist
(617) 349-0205
SOURCE Transkaryotic Therapies, Inc.
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CONTACT:
Daniella Lutz, Corporate Communications
Specialist of Transkaryotic Therapies, Inc., +1-617-349-0205
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