TKT Announces Victory in Genzyme Patent Litigation - No Infringement; Trial Cancelled -
CAMBRIDGE, Mass., Dec 17, 2001 /PRNewswire via COMTEX/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX chart, msgs) today announced that the Honorable Gregory M. Sleet of the U.S. District Court of Delaware has informed the parties he will dismiss the patent litigation Genzyme Corporation and Mount Sinai School of Medicine brought against TKT. The suit, brought last year, claimed that TKT's activities relating to Replagal(TM) (agalsidase alfa) enzyme replacement therapy for the treatment of Fabry disease infringe one or more claims of U.S. Patent No. 5,356,804. The order came in response to a motion by Genzyme asking the Court to clarify its recent "Markman" ruling construing the term "chromosomally integrated."
"We are pleased with the decision that our Replagal product does not infringe their patent," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "The fact that the Court decided to dismiss this case before completing briefing on our motions for summary judgment of non-infringement and invalidity confirms our belief that this was a frivolous case. The important thing now is that our time, resources and energy can be focused on improving the lives of patients with Fabry disease."
Conference Call and Webcast
In connection with this press release, TKT will host a conference call at 1:00 pm EST today, Monday, December 17, 2001. Participants may access the call by dialing (706) 679-4323 and referencing access code 2711935. The call will also be broadcast live over the Internet at www.tktx.com under the Investor Information section. Please dial in 5 to 10 minutes prior to the scheduled conference call time or log on to the website at least 15 minutes prior to the call in order to register, download, and install any necessary software.
About TKT and Replagal Replagal enzyme replacement therapy for the treatment of Fabry disease has been approved in the European Union and several other nations, and is being reviewed by the U.S. Food and Drug Administration in the United States.
Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Niche Protein(R) products, Gene- Activated(R) proteins, and gene therapy. The Company's Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. TKT's gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. The Company's gene therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.
This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward- looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward- looking statements. 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 set forth under the caption "Risk Factors" in the Company's Current Report on Form 8-K filed December 13, 2001 which is on file with the Securities and Exchange Commission and incorporated herein by reference. These include, without limitation, the following: (1) whether any of the Company's Niche Protein, Gene-Activated protein, or gene therapy product candidates will advance in the clinical trial process, (2) whether such clinical trials will proceed in a timely manner, (3) whether the clinical trial results will warrant continued product development, (4) whether the required regulatory filings, such as Investigational New Drug applications and Biologics License Applications, are made in a timely manner, (5) whether the Company's products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies, (6) if such products receive approval, whether they will be successfully distributed and marketed, (7) whether patent litigation in which the Company is involved or may become involved, including the litigation described in this release, are resolved in a manner adverse to the Company, (8) the effects of competitive products on the Company's proposed products, and (9) the Company's dependence on third parties, including collaborators, manufacturers and distributors. In addition, any forward-looking statements represent the Company's expectations only as of the date hereof and should not be relied upon as representing the Company's expectations as of any subsequent date. 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), Niche Protein(R), and TKT(R) are registered trademarks and Replagal(TM) and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc.
Please visit our web site at www.tktx.com for additional information about Transkaryotic Therapies, Inc.
CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
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Source: Transkaryotic Therapies, Inc.
Contact:
Justine E. Koenigsberg, Director, Corporate Communications of
TKT, +1-617-349-0271
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