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Dainippon Sumitomo Pharma Announces Launch of "Replagal(R) 3.5 mg" for Anderson-Fabry Disease.

Tokyo, Japan, Feb 15, 2007 - (JCN Newswire) - Dainippon Sumitomo Pharma Co., Ltd. (DSP) announces the upcoming launch on the 15

of February 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.

Profile of "Replagal(R) 3.5 mg"
Brand Name: Replagal(R) 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 Recombi-
 nation) is administered by infusion every other
 week at a dose of 0.2 mg/kg body weight.
Marketing Authorization
 Holder: 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


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 www.ds-pharma.co.jp

Source: Dainippon Sumitomo Pharma

Contact:
Dainippon Sumitomo Pharma Co., Ltd.
Public Relations Department
Tel: +81-6-6203-1407
Fax: +81-6-6203-5548


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Date:Feb 15, 2007
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