CAMBRIDGE, Mass., July 23 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) announced today that the European Commission
has approved its Cambridge, Massachusetts facility for the commercial
manufacture of agalsidase alfa, the active ingredient in Replagal(TM) enzyme
replacement therapy for the treatment of Fabry disease. The company will
continue to use contract manufacturers to perform Replagal finish-and-fill
services.
"We are extremely pleased to have received approval of our first cGMP
manufacturing facility. The rapid approval of this plant is a credit to our
engineering, manufacturing, and quality teams," said David D. Pendergast,
Ph.D., Executive Vice President, Operations of TKT. "By bringing these
manufacturing capabilities in-house, we believe we will be able to continue
improving the efficiency of our manufacturing processes, and thus
substantially improve our product margins."
In the same Cambridge, Massachusetts manufacturing facility, TKT is
manufacturing its Hunter syndrome product, iduronate-2-sulfatase for clinical
trials. The pivotal trial for this product is scheduled to start later this
year.
About Replagal
Replagal is a fully human alpha-galactosidase A protein, produced by
genetic engineering technology, intended for long-term treatment of Fabry
disease. It replaces the deficient alpha-galactosidase A with active enzyme
to halt or reverse the disease process. Since August 2001, Replagal has been
approved for commercial use in 26 countries, including the 15 countries of the
European Union. In the United States, Replagal is an investigational product.
About TKT
TKT is a biopharmaceutical company developing therapeutics for the
treatment of rare genetic diseases caused by protein deficiencies. The
company currently markets one product, Replagal(TM) (agalsidase alfa) for the
treatment of Fabry disease in the European Union and certain other countries.
TKT is headquartered in Cambridge, Massachusetts and has a majority-owned
subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European
sales and marketing activities of Replagal. Additional information on TKT is
available on the Company's website at http://www.tktx.com.
This press release contains forward-looking statements regarding the
manufacture of Replagal and iduronate-2-sulfatase, as well as statements
containing the words "believes," "anticipates," "plans," "expects,"
"estimates," "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 statements regarding the Company's
ability to successfully operate its manufacturing facility, the Company's
ability to ensure compliance at the facility with applicable regulations, the
Company's ability to manufacture Replagal or iduronate-2-sulftase at a
commercially reasonable cost, the ability of TKT's contract manufacturers to
perform finish-and-fill services in a timely manner and in accordance with
applicable regulatory guidelines, 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 March 31, 2003, which is
on file with the Securities and Exchange Commission and 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.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
SOURCE Transkaryotic Therapies, Inc.
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Related links:
http://www.tktx.com
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CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications of Transkaryotic Therapies, Inc., +1-617-349-0271
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