CAMBRIDGE, MA, Feb. 9 /PRNewswire-FirstCall/ -- Transkaryotic Therapies,
Inc. (Nasdaq: TKTX) announced today it has received regulatory approval from
Health Canada to market Replagal(TM) (agalsidase alfa) enzyme replacement
therapy for the treatment of Fabry disease, a life-threatening disorder
affecting over 250 men and women in Canada. Health Canada approved Replagal
for the treatment of Fabry disease under its Notice of Compliance with
Conditions (NOC/c) Policy. Under this policy, TKT may begin selling Replagal
in Canada for the treatment of Fabry disease while the company conducts post-
marketing studies. TKT intends to launch Replagal promptly in Canada and to
initiate sales as it receives reimbursement approval in the provinces. TKT
will have overall responsibility for marketing and sales while Paladin Labs
Inc., a specialty pharmaceutical company in Montreal, will have exclusive
distribution rights for Replagal in Canada and will coordinate certain other
post-marketing initiatives including logistics and reimbursement.
"We are extremely pleased Health Canada recognized the important benefits
of Replagal in fighting Fabry disease," said Michael J. Astrue, President and
Chief Executive Officer of TKT. "Canada has been a critical location for our
Replagal clinical trials, and we are delighted to be expanding our presence
there."
"It is gratifying to know there is new hope for Fabry patients in Canada,"
said Dr. Joe T. R. Clarke, of the Division of Clinical & Metabolic Genetics at
the Hospital for Sick Children in Toronto. "I have seen the devastating
effects of Fabry disease in men and women who previously had no therapeutic
options. With Replagal, we can offer patients in Canada a treatment option
for the first time that improves their lives in significant ways."
"Today is an important day for the Canadian Fabry community," said Dr.
Michael West of the Department of Medicine at Dalhousie University, Queen
Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. "Replagal
has been shown to have a clinical benefit with significant symptomatic
improvement in Fabry disease. Patients will benefit from this treatment with
little disruption in their lives due to the relatively short infusion time.
Indeed, many patients in Canada have already received Replagal at home rather
than in a hospital setting."
Patients and physicians in Canada seeking additional medical information
about Replagal and Fabry disease should call Paladin's Medical Information
group at 1-888-550-6060.
About Replagal(TM)
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. Replagal is approved for commercial
use in 28 countries, including Canada and the 15 countries of the European
Union.
About Fabry Disease
Fabry disease is a rare, inherited genetic disorder caused by deficient
activity of the lysosomal enzyme alpha-galactosidase A. It affects both males
and females, which results in premature mortality in the fourth or fifth
decade of life due to kidney disease, heart disease and stroke. An estimated
5,000 patients worldwide are affected by Fabry disease. Due to its rarity and
vast array of symptoms, diagnosis is often difficult and affected men and
women have a significantly reduced quality of life and a greatly shortened
life expectancy.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company committed to
developing treatments for rare diseases caused by protein deficiencies with a
core focus on lysosomal storage diseases. The company markets one product,
Replagal(TM), an enzyme replacement therapy for Fabry disease in Europe and
other countries and is developing treatments for Hunter syndrome and Gaucher
disease. TKT's research pipeline is focused on rare diseases where a
significant unmet medical need exists. TKT was founded in 1988 and is
headquartered in Cambridge, Massachusetts, with additional operations in
Europe, Canada and Latin America. Additional information about TKT is
available on the company's website at http://www.tktx.com.
This press release contains forward-looking statements, including
statements regarding Canadian approval of Replagal and the anticipated
Canadian commercial launch of Replagal, and other statements containing the
words "believes," "anticipates," "plans," "expects," "will" and similar
expressions. 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. Important
factors that could cause results to differ include, but are not limited to:
when reimbursement will be finalized in various Canadian provinces, if at all;
the size of the Canadian market for Replagal; the impact of competing products
on the Canadian market for the treatment of Fabry disease, including with
respect to the market acceptance of Replagal; Paladin Labs' ability to
distribute Replagal in Canada; 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, 2003 which risk
factors are on file with the Securities and Exchange Commission and are
incorporated herein by reference. The company does not undertake any
obligation to update any forward-looking statements.
Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.
Contact:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
Daniella M. Lutz
Corporate Communications Specialist
(617) 349-0205
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, +1-617-349-0271, or Daniella M. Lutz, Corporate
Communications Specialist, +1-617-349-0205, both of TKT
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