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Genzyme Corporation (GENZ) Files Suit Against Transkaryotic Therapies, Inc. (TKT) (TKTX) For Glucocerebrosidase Patent Infringement; Sues To Halt TKT Gaucher Trial



10/19/2005 5:12:32 PM

CAMBRIDGE, Mass., Jan. 24 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) 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® 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® 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® 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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