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Dainippon Sumitomo Pharma Co., Ltd.:Launch of 'Replagal 3.5 mg' for Anderson-Fabry Disease

TOKYO, Feb. 14, 2007-Dainippon Sumitomo Pharma Co., Ltd.(DSP) announces the upcoming launch on the 15 of February of "Replagal 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 ?-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 from the U.S. company,. Shire Human Genetic Therapies, 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 ?-galactosidase-A enzyme preparation produced from human cell cultures through Gene Activation® 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.

(Reference Sheet)

Profile of "Replagal 3.5 mg"

Brand Name: Replagal for intravenous infusion 3.5 mg

Nonproprietary Name: Agalsidase alfa (Genetic Recombination)

Dose Form and Strength: Vial preparation, with 3.5 mg Agalsidase alfa (Genetic

Recombination) per vial (3.5 mL)

Indication: Anderson-Fabry disease

Dosage and Administration: Generally, Agalsidase alfa (Genetic Recombination) is

administered by infusion every other week at a dose of 0.2

mg/kg body weight.

Marketing Authorization


Dainippon Sumitomo Pharma Co., Ltd.

Approval Date: October 20, 2006

Date of NHI Price Listing: December 1, 2006

NHI Drug Price Standard: 3.5 mg vial: 357,307 yen per

Package Contents: 1 vial

Posted: February 2007