Genzyme Sues to Halt TKT Gaucher Trial
January 24 2005 - 2:59PM
PR Newswire (US)
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
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