Transkaryotic Therapies (NASDAQ:TKTX)
Historical Stock Chart
From May 2019 to May 2024
Genzyme Sues to Halt TKT Gaucher Trial
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
http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO
http://photoarchive.ap.org/
DATASOURCE: Transkaryotic Therapies, Inc.
CONTACT: Justine E. Koenigsberg, Senior Director, Corporate
Communications, +1-617-349-0271
Web site: http://www.tktx.com/
Company News On-Call: http://www.prnewswire.com/comp/120657.html