"Squarekids® subcutaneous injection syringe", a tetravalent combination vaccine for the prevention of diphtheria, pertussis, tetanus, and poliomyelitis (polio) will be launched

Daiichi Sankyo Co., Ltd. (head office: Chuo-ku, Tokyo; Representative Director, President and CEO: Joji Nakayama (hereinafter "Daiichi Sankyo")), Japan Vaccine Co., Ltd. (head office: Chuo-ku, Tokyo; Representative Director and President: Toshihiro Ishikiriyama (hereinafter "Japan Vaccine")), and Sanofi K.K. (head office: Shinjuku-ku, Tokyo; Representative Director and President, Fabrice Baschiera (hereinafter "Sanofi")) announced that they will launch "Squarekids® subcutaneous injection syringe", a tetravalent combination vaccine (DPT-IPV) for the prevention of diphtheria, pertussis, tetanus and poliomyelitis (polio) on December 9, 2015.

Squarekids® is a product manufactured by Kitasato Daiichi Sankyo Vaccine Co., Ltd. (head office: Kitamoto-shi, Saitama; Representative Director and President: Takeshi Ogita (hereinafter "Kitasato Daiichi Sankyo Vaccine")), a Group company in Japan of Daiichi Sankyo. This product is a combination vaccine containing DPT vaccine of Kitasato Daiichi Sankyo Vaccine and inactivated polio vaccine (Salk vaccine) of Sanofi filled in prefilled syringes, which is the first tetravalent DTP-IPV combination vaccine in Japan that contains Salk inactivated polio vaccine. 

Daiichi Sankyo Group, Japan Vaccine and Sanofi Pasteur, the vaccines division of Sanofi Group, are committed to contributing to protection of the health of people in Japan by bringing innovative vaccines with high medical needs and by promoting the importance of preventative medicine.

Product Overview

Brand name

Squarekids®subcutaneous injection syringe

Non-proprietary name

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

Regulatory category applicable to this drug

Biological product, powerful drug, prescription drug (Note: to be used under the prescription by physicians)

Dosage form/Strength

Each 0.5 mL dose of this vaccine contains ≥4 units of  the Bordetella pertussis protective antigen, ≤15 Lf (≥14 international units) of diphtheria toxoid, ≤2.5 Lf (≥9 international units) of tetanus toxoid, 40 DU of inactivated poliovirus type 1, 8 DU of inactivated poliovirus type 2, and 32 DU of inactivated poliovirus type 3.

Indication

Prevention of diphtheria, pertussis, tetanus, and acute poliomyelitis

Dosage and administration

Primary immunization: The usual primary series for children consist of three doses of 0.5 mL each given by subcutaneous injection at intervals of at least 3 weeks.

Booster immunization: The usual booster dose for children is a single 0.5 mL dose given by subcutaneous injection at least 6 months after the primary immunization.

Date of approval

July 4, 2014

Manufacturing and marketing license holder

Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Distributor

Daiichi Sankyo Co., Ltd.

Co-marketing companies

Japan Vaccine Co., Ltd.

Sanofi K.K.

 

Contact:

Daiichi Sankyo Co., Ltd.

Corporate Communication Department
For press: Phone 03-6225-1126
For investors:  Phone 03-6225-1125

Japan Vaccine Co., Ltd.

Corporate Affairs: Phone 03-5213-2713

Sanofi K.K.
Communications
Phone: 03-6301-4148
Website: http://www.sanofipasteur.jp/

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: www.daiichisankyo.com.

About Japan Vaccine

Japan Vaccine Co., Ltd. started its operations on July 2, 2012, a joint venture company equally owned by GlaxoSmithKline K.K. and Daiichi Sankyo Co., Ltd. As a company specialized in providing vaccines to prevent infectious diseases and thereby meeting social needs, Japan Vaccine is operating with a mission of "contributing to the establishment of preventive measures against communicable diseases through collaborations with diverse stakeholders."

About Sanofi

Sanofi Group, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. It is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). In Japan, Sanofi K.K. has approximately 2,650 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 http://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 a broad 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.

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