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Hib Vaccine TAK-816 Enters into the Phase III Clinical Trial in Japan

Osaka, Japan, June 15, 2011 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it will initiate the phase III clinical trial in Japan of the vaccine for preventing infections caused by Haemophilus Influenzae type b*1 (“Hib”) (development code: TAK-816).

TAK-816 is a Hib vaccine licensed from Novartis (head office: Switzerland) in May 2009 (Novartis' product name: Vaxem Hib®). It is a liquid form vaccine with enhanced immunogenicity*3 by combining polyribosylribitol phosphate (PRP) *2 with non-toxic mutant of diphtheria toxin. Hib is known as a main cause of bacterial meningitis, which is an infection of the membrane covering the brain and spinal cord. In particular, the prognosis of Hib-induced meningitis is often unfavorable with subsequent outcomes such as epilepsy, auditory disturbance, and development disorders. As it can even be fatal, it is critically important to prevent the disease by vaccination.

“We will promote the development of TAK-816 and provide the product for patients as soon as possible to fulfill our social responsibilities as a pharmaceutical company,” said Masato Iwasaki, Corporate Officer, Senior Vice President, Strategic Product Planning Department of Takeda. “We have been stably supplying pediatric vaccines for more than 60 years in Japan. We hope that the enhancement of our vaccine business will contribute to the improvement of vaccination environment here. We also plan to continue the development of various combination vaccines that are effective and safe by using TAK-816 and polio vaccine (S-IPV), in view of future global expansion of this business.”

* *1 About Hib ( Haemophilus Influenzae type b )
o Main cause of pediatric bacterial meningitis. It is completely different from virus which causes “flu.”
* *2 PRP ( polyribosylribitol phosphate )
o Antigen of hib vaccine, which is a polyssacharide existing in the cell surface of Hib.
* *3 Immunogenicity
o Induces production of antigens.

Posted: June 2011