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Replagal

Shire Pharmaceuticals Group PLC

Drug Names(s): agalsidase alfa

Description:

Replagal (agalsidase alfa) is an enzyme replacement therapy indicated for use in the treatment of Fabry disease. Patients with Fabry disease have a deficiency of the enzyme alpha-galactosidase A. This enzyme deficiency results in an accumulation of a toxic lipid called globotriaosylceramide or Gb3 in various organs of the body, including the nervous system, kidneys, and heart. Administration of Replagal is an attempt to restore normal levels of enzyme activity and alleviate some of the effects of the disease. As Replagal is an enzyme replacement therapy, it is a protein drug. Specifically, Replagal contains the human enzyme a-galactosidase A produced by genetic engineering in a continuous human cell line.

Deal Structure: Sumitomo
In July 1998, Transkaryotic (TKT) entered into an exclusive distribution agreement with Sumitomo to commercialize Replagal in Japan, Korea, and China. Under the agreement, Sumitomo is responsible, at its own expense, for development and commercialization of Replagal in the territories covered by the agreement. Sumitomo is required to purchase Replagal from the Company for sale in the territories covered by the agreement for a transfer price calculated as a percentage of net sales. Under the agreement, TKT has the potential to receive up to $8.0 million upon the achievement of regulatory milestones, of which TKT had received $3.0 million at December 31, 2002. The agreement expires on a country-by-country basis 15 years after Sumitomo begins selling Replagal in the respective country.

TKT Europe
In April 2000, the Company established a subsidiary in Sweden known as TKT Europe-5S AB (TKT Europe) for the purpose of marketing, selling and distributing...See full deal structure in Biomedtracker

Partners: Sumitomo Dainippon Pharma Co., Ltd.


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