For Immediate Release

Asubio Pharma Co., Ltd.
DAIICHI SANKYO COMPANY, LIMITED

Asubio Pharma’s Inherited Metabolic Disease Agent Biopten®Receives Approval for Additional Indication

Asubio Pharma Co., Ltd. (Asubio Pharma; Head Office: Minato-ku, Tokyo; President & CEO: Seiichi Yokoyama), one of the group companies of DAIICHI SANKYO COMPANY, LIMITED, announced an additional indication for the inherited metabolic disease agent Biopten^®(generic name: sapropterin hydrochloride) for the treatment of "tetrahydrobiopterin (BH4) responsive hyperphenylalaninemia (HPA)."

  The pharmaceutical Biopten^® is a highly pure chemically synthesized form of the BH4 that occurs naturally in the human body. It treats HPA patients by ameliorating the serum phenylalanine level as summarized below.

 

 

  Maruho Co., Ltd. marketed Biopten^® under a contract that expired at the end of June, 2008. From July 1, DAIICHI SANKYO COMPANY, LIMITED began marketing Biopten^® under a contract.

 

For inquiries:
Asubio Pharma Co., Ltd., Management Planning Department, Tel: +81-3-3588-9600
DAIICHI SANKYO COMPANY, LIMITED, Corporate Communication Department,
Tel:+81-3-6225-1126

Reference:

 

About Biopten^®

Biopten^®, an inherited metabolic disease agent, was developed by the Pharmaceuticals Division of Suntory Limited (now Asubio Pharma Co., Ltd.) for the treatment of atypical HPA and launched in 1992 in Japan. The recently approved additional indication is an authorized orphan drug for treating rare diseases. In the year ended March 2008, sales of Biopten^® in Japan on a National Health Insurance price basis were approximately ¥1 billion.

 

About BH4 Responsive HPA

 

HPA results because of an inability to metabolize the essential amino acid phenylalanine due to a genetic disorder in phenylalanine hydroxylase. This metabolic abnormality is expressed as an inability to maintain blood phenylalanine levels within the normal range. If treatment does not begin soon after birth, the accumulation of phenylalanine causes mental retardation and other irreversible damage to the central nervous system. Treatment was not previously available in Japan, except for a restricted phenylalanine diet. However, strict, long-term control of protein intake through dietary management was difficult.

 

Research of this treatment in Japan in 1999 was the first in the world to confirm subtypes in which treatment with Biopten^® normalized blood phenylalanine levels. Subsequent clinical research confirmed long-term efficacy in maintaining blood phenylalanine levels within a normal range. Continued use of Biopten^® promotes normal development while notably improving treatment compliance, and we expect Biopten^® to improve the quality of life of infants diagnosed with the condition as well as their parents.

 

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