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Daiichi Sankyo announces cooperative sales agreement for the recombinant adsorbed hepatitis B vaccine “Bimmugen®”

Posted: 28 August 2014 | | No comments yet

Daiichi Sankyo Company, Limited announced that it has signed a cooperative sales agreement with The Chemo-Sero-Therapeutic Research Institute on August 22 for its recombinant adsorbed hepatitis B vaccine (yeast-derived), Bimmugen®…

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Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has signed a cooperative sales agreement with The Chemo-Sero-Therapeutic Research Institute (hereafter, “Kaketsuken”) on August 22 for its recombinant adsorbed hepatitis B vaccine (yeast-derived), Bimmugen® (here after, “the vaccine”).

Kaketsuken originally obtained approval for the vaccine in 1988 as a genetic recombinant drug manufactured using proprietary Japanese technology. The main aim of the vaccine is prophylaxis against hepatitis B, and to date the vaccine has been administered to over 4 million people in Japan.

This agreement grants Daiichi Sankyo the right to sell the vaccine in Japan, which it hopes will aid prevention of hepatitis B, as well as further raise the company’s presence in the Japanese vaccine market.

Through the sale of vaccines to meet unmet medical needs, Daiichi Sankyo is continuing its efforts to contribute to public health and the diversification of preventative medicine in Japan.

Product Overview

Name

Bimmugen® 0.25mL

Bimmugen® 0.5mL

Generic Name

Recombinant adsorbed hepatitis B vaccine (yeast-derived)

Classification

Powerful medicine, prescription medicine (Caution: To be prescribed by a doctor or other medical professional)

Content

0.25mL / 0.5mL vials

Indication

Prophylaxis against hepatitis B, prevention of maternally transmitted hepatitis B, prevention of hepatitis B infection via HBs antigen-positive or HBe antigen-positive contaminated blood.

Dosage / Administration

1. Prophylaxis against hepatitis B: Administer two 0.5mL doses subcutaneously or intramuscularly, with an interval of 4 weeks between administrations, followed by one further 0.5mL dose 20-24 weeks after the second administration. For children under the age of 10, administer 0.25mL doses subcutaneously following the above schedule. Continue with injections if active HBs antibodies are not acquired.

2. Prevention of maternally transmitted hepatitis B (combination therapy with anti-HBs immune globulin): Administer one dose of 0.25mL subcutaneously within 12 hours of birth, followed by two further 0.25mL doses one month and six months after the initial administration. Continue with injections if active HBs antibodies are not acquired.

3. Prevention of hepatitis B infection via HBs antigen-positive or HBe antigen-positive contaminated blood (combination therapy with anti-HBs immune globulin): Administer one dose of 0.5mL subcutaneously or intramuscularly within 7 days of exposure to contaminated blood, followed by two further 0.5mL doses one month and 3-6 months after the initial administration. For children under the age of 10, administer 0.25mL doses subcutaneously following the above schedule. Continue with injections if active HBs antibodies are not acquired.

Approval date

March 29, 1988

Manufacturer

The Chemo-Sero-Therapeutic Research Institute (Kaketsuken)

Seller

Daiichi Sankyo, Limited

Cooperative Seller

Japan Vaccine Co., Ltd.

 

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