TOKYO, Japan I July 04, 2014 I Daiichi Sankyo Co., Ltd. (hereinafter Daiichi Sankyo) and Sanofi K.K. announce that Kitasato Daiichi Sankyo Vaccine Co., Ltd. (hereinafter Kitasato Daiichi Sankyo Vaccine), a Daiichi Sankyo Group company in Japan, has obtained a manufacturing and marketing licensing in Japan for the 4-valent combination vaccine for the prevention of Pertussis, Diphtheria, Tetanus and Poliomyelitis (Polio) (hereinafter “this vaccine”).

This vaccine is a product made of precipitated and purified pertussis, diphtheria, tetanus (DPT vaccine) of Kitasato Daiichi Sankyo and inactivated polio vaccine (Salk vaccine) (eIPV:Enhanced Inactivated Poliomyelitis Vaccine) of Sanofi Pasteur in a prefilled syringe, and is the first 4-valent combination vaccine in Japan that contains inactivated polio vaccine (Salk vaccine). 

Daiichi Sankyo Group and Sanofi Pasteur are committed to contributing towards protecting the health of people in Japan by introducing innovative vaccines with high medical needs and by promoting the importance of preventative medicine in Japan. 

Product Overview

Commercial Name

Squarekids® subcutaneous injection syringe

Generic Name

Precipitated and purified pertussis-diphtheria-tetanus-inactivated polio vaccine (Salk vaccine) vaccine

Regulatory category applicable to this drug

Biological product, drastic medicine, prescription drug (Note – to be used under physician’s prescription

Specification-Content

This drug contains in its 0.5ml, the equivalency of 4 units and over of protective antigen of Bordetella pertussis, 23.5 units and over of diphtheria toxoid, 13.5 units and over of tetanus toxoid, 40 D-antigen units 8 D-antigen units and 32 D-antigen units of inactivated polio virus type I, type II and type III respectively.

Effect-Efficacy

Prevention of pertussis, diphtheria, tetanus and poliomyelitis

Dosage-Administration

Primary immunization: Normally, 3-dose administration to children by subcutaneous injection, each dose containing 0.5ml, with an interval of 3 weeks or longer.

Booster immunization: Normally, one dose of 0.5ml administration to children by subcutaneous injection, with an interval of 6 months or longer.

Approval date of manufacturing and marketing license

July 4, 2014

Manufacturing and marketing license holder

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Distributor

Daiichi Sankyo Co., Ltd.

Marketing alliance parties

Sanofi K.K.

Japan Vaccine Co., Ltd.

For further inquiries:

Daiichi Sankyo Co., Ltd. Corporate Communications Department

Media TEL: +81-3-6225-1126

Investors/Analysts TEL: +81-3-6225-1125

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises.

Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. 

The Daiichi Sankyo Group has created a “Hybrid Business Model,” to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ need. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).

In Japan, Sanofi K.K. has approximately 2,700 employees nationwide. The company develops, manufactures, and markets pharmaceutical products under the vision to become the most trusted healthcare leader bringing health and happiness to Japan. Please visit the company’s website (www.sanofi.co.jp) for details.

About Sanofi Pasteur

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

 SOURCE: Daiichi Sankyo