Dainippon Sumitomo Pharma Co., Ltd. (DSP) announces the upcoming launch of "Replagal(R) 3.5 mg" (nonproprietary name: Agalsidase Alfa (Genetic Recombination)) hereafter, Replagal.
Anderson-Fabry disease is a lysosomal storage disorder caused by congenitally deficient or reduced activity of a-galactosidase-A, a hydrolytic enzyme present in intracellular lysosomes. Anderson-Fabry disease is a multi-system disorder in which, glycosphingolipids, which should normally be broken down, progressively accumulate within cells and tissues as ceramide trihexoside (CTH) resulting in tissue and organ dysfunction, in particular kidney disease, heart disease, and stroke.
Licensed for sale in Japan from Shire Human Genetic Therapies, Inc. (Cambridge, Massachusetts, USA), Replagal was first approved in the EU in August of 2001 and Japan is the 40th countries where the approval for Replagal is granted. Replagal is characterized by the following features:
1. It is an alpha-galactosidase-A enzyme preparation produced from human cell cultures through Gene Activation(R) technology.
2. It reduces accumulation of CTH, the causative agent of Anderson-Fabry disease, through an intravenous infusion of 40 minutes or more once every two weeks.
3. It is expected to reduce pain, caused by Anderson-Fabry disease, that significantly affects patient QOL, and to impede the progression of, and improves, renal and cardiac impairment.
Through this launch of Replagal, DSP is proud to contribute to the treatment of patients with Anderson-Fabry disease.
About Dainippon Sumitomo Pharma
Dainippon Pharmaceutical and Sumitomo Pharmaceuticals merged on October 1, 2005, to create Dainippon Sumitomo Pharma (TSE: 4506), a new corporation committed to serving the social good through research and development programs designed to empower people to lead fuller, healthier lives. Among the capabilities being deployed to create new value for shareholders and customers alike are research and development programs that excel in sophistication and creativity, quality and production systems that ensure the enduring trust of our customers, some of Japan's most developed sales and marketing resources, and an unmatched ability to provide reliable data to medical decision-makers. For more information, please visit http://www.ds-pharma.co.jp.
Dainippon Sumitomo Pharma
http://www.ds-pharma.co.jp
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