FOR IMMEDIATE RELEASE
PALADIN SIGNS EXCLUSIVE DISTRIBUTION AGREEMENT FOR REPLAGAL™ WITH TRANSKARYOTIC THERAPIES, INC.
Montreal, Canada, February 9, 2004 - Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, today announced that it has entered into an exclusive Canadian distribution agreement with Transkaryotic Therapies, Inc. (“TKT”) (NASDAQ: TKTX) for Replagal™ (agalsidase alfa), an innovative treatment for Fabry disease. Health Canada recently granted TKT regulatory approval for Replagal™, a long-term enzyme replacement therapy for the treatment of Fabry disease under its Notice of Compliance with Conditions (NOC/c) Policy. Approval of a product under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs. Conditions associated with approval allow Health Canada to monitor the safety and effectiveness of the drug through enhanced post-market surveillance.
Fabry disease is a genetic lysosomal storage disorder caused by a deficiency of an enzyme known as alpha-galactosidase A. In patients with Fabry disease, the alpha-galactosidase A enzyme is either partially or completely deficient, thereby restricting the body’s ability to break down a fatty substance called globotriaosylceramide (Gb3) which leads to damage of major organs, including the kidney and heart. The disease is characterized by recurrent episodes of severe pain in the extremities, heat intolerance, gastrointestinal difficulties, inability to sweat, skin blemishes, and cloudiness of the cornea. Advanced consequences include kidney failure, and impaired arterial circulation leading to heart attacks and strokes. It is estimated that 5,000 people are affected with Fabry disease worldwide.
“Fabry disease is a devastating condition and we are pleased to partner with Transkaryotic Therapies to bring Replagal™ to Fabry patients here in Canada,” said Jonathan Ross Goodman, President and CEO of Paladin. “As we move forward with the commercialization of this product, we will seek collaboration from the reimbursement authorities to provide all patients with equal access to this therapy.”
For more information about Replagal™ please consult www.tktx.com, or contact Paladin’s Medical Information group at 1-888-550-6060.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a leading specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada’s leading specialty pharmaceutical companies. Paladin’s shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Paladin Web Site at www.paladinlabs.com.
About Transkaryotic Therapies, Inc.
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™, 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 news release may contain forward-looking statements or predictions. These statements represent our judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitability, and obtaining marketing approval and other factors that are discussed in the Management Discussion and Analysis published in the Company's annual report.
For more information please contact:
Samira Sakhia
Chief Financial Officer
Paladin Labs Inc.
Tel: (514) 340-5067
email: info@paladin-labs.com
Website: www.paladinlabs.com
Bruce Wigle
Investor Relations
The Equicom Group Inc.
Tel: (416) 815-0700 ext. 228
email: bwigle@equicomgroup.com
Justine E. Koenigsberg
Director, Corporate Communications
Transkaryotic Therapies, Inc.
Tel: (617) 349-0271
email: jkoenigsberg@tktx.com
Website: www.tktx.com