TKT to Defend Patent Suit in Israel
CAMBRIDGE, Mass., Jan. 24 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today announced that Genzyme Corporation has
filed suit against TKT in the District Court of Tel-Aviv-Jaffa but not yet
formerly served process on TKT. The suit claims that TKT's Phase I/II
clinical trial evaluating its investigational Gene-Activated(R)
glucocerebrosidase (GA-GCB) for the treatment of Gaucher disease infringes one
or more claims of Israeli Patent No. 100,715. In addition, Genzyme filed a
motion for preliminary injunction, including a request for an ex parte hearing
and relief on the merits, to immediately seize and destroy all GA-GCB being
used to treat patients in TKT's ongoing clinical trial and to prevent the
company from submitting data generated from the clinical trial to regulatory
agencies. The judge has already rejected Genzyme's request for ex parte
relief.
"We believe Genzyme's efforts to try and disrupt our ongoing clinical
development of GA-GCB are an improper attempt to extend its monopoly in the
area of Gaucher disease," said Kerry A. Flynn, Vice President of Intellectual
Property and Licensing at TKT. "We do not believe we infringe any valid claim
or that there is a reasonable likelihood that this unprecedented tactic will
interrupt our clinical trial. We intend to honor our commitment to continue
treating our Gaucher patients with GA-GCB."
TKT is conducting an open-label Phase I/II study to evaluate the safety
and clinical activity of GA-GCB. The study enrolled twelve patients with Type
I Gaucher disease from several countries. TKT expects to report top-line data
from this study in the second half of 2005.
Gaucher disease is the most common of the inherited lysosomal storage
diseases and is caused by a deficiency of the enzyme glucocerebrosidase. As a
result of this deficiency, certain lipids accumulate in specific cells of the
liver, spleen, and bone marrow causing significant clinical symptoms in the
patient, including enlargement of the liver and spleen, hematologic
abnormalities, and bone disease.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily
focused on researching, developing and commercializing treatments for rare
diseases caused by protein deficiencies. Within this focus, the company
markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is
developing treatments for Hunter syndrome and Gaucher disease. In addition to
its focus on rare diseases, TKT intends to commercialize Dynepo(TM), its Gene-
Activated(R) erythropoietin product for anemia related to kidney disease, in
the European Union. TKT was founded in 1988 and is headquartered in Cambridge,
Massachusetts, with additional operations in Europe, Canada and South America.
Additional information about TKT is available on the company's website at
http://www.tktx.com.
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including statements
containing the words "believes," "anticipates," "plans," "expects," "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 Genzyme will be successful in asserting its patents against the
company in Israel and elsewhere; whether GA-GCB will advance in the clinical
trials process; the timing of such clinical trials; whether the clinical trial
results will warrant continued product development; whether the Company's
products will receive approval from the U.S. Food and Drug Administration or
equivalent regulatory agencies, and, if such products receive approval,
whether they will be successfully marketed; the results of any patent
litigation in which the Company is involved or may become involved, including
the patent litigation referred to in this release; competition; the Company's
dependence on collaborators; and other factors set forth under the caption
"Certain Factors That May Affect Future Results" in the company's Quarterly
Report on Form 10-Q for the quarter ended September 30, 2004, which is on file
with the Securities and Exchange Commission and which factors 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.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Sanofi-Aventis SA.
For More Information Contact:
Justine E. Koenigsberg
Senior Director, Corporate Communications
(617) 349-0271
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
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CONTACT:
Justine E. Koenigsberg, Senior Director,
Corporate Communications, +1-617-349-0271
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