The advisory panel will meet to discuss Replagal on September 27, 2002.
Message 17706240
Monday July 8, 1:38 pm Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Announces Meeting of FDA Advisory Committee to Review Replagal(TM) BLA for Fabry Disease
- Endocrinologic and Metabolic Drugs Advisory Review Scheduled for September 27, 2002 -
CAMBRIDGE, Mass., July 8 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) today announced that the Company's Biologics License Application (BLA) for Replagal(TM) (agalsidase alfa), an enzyme replacement therapy for the long-term treatment of Fabry disease, will be considered before the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee. The advisory panel will meet to discuss Replagal on September 27, 2002.
"We are pleased that the FDA is taking this next, important step in the review of our BLA," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "We look forward to the opportunity to make Replagal available to patients in the United States."
Advisory committees provide the FDA with independent advice on marketing applications. The FDA generally follows the recommendations of its advisory committees, but is not bound to do so.
Since August 2001, Replagal has been approved for commercial use in over 20 countries, including the European Union, the Czech Republic, Iceland, Israel, New Zealand, Norway, and Switzerland.
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® products, Gene- Activated® 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 regarding the possible approval of Replagal. These forward-looking statements are based on the Company's opinion and expectations as of the date hereof and are subject to risks and uncertainties that could cause actual results to differ materially. Factors that could cause results to differ include, but are not limited to, the outcome or changes in timing of the advisory committee meeting, the potential timing of FDA approval, whether future trials will need to be conducted, whether competing products will reduce any market opportunity that may exist, and other factors set forth under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ending March 31, 2002 which is on file with the Securities and Exchange Commission and which is incorporated herein by reference. The Company does not undertake any obligation to update any forward-looking statements.
Gene-Activated® and Niche Protein® are registered trademarks and Replagal(TM) and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc. For additional information please visit the Company's website at www.tktx.com.
CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
SOURCE: Transkaryotic Therapies, Inc. |
