Japan Poliomyelitis Research Institute (JPRI) and Takeda Pharmaceutical Company Limited jointly announced that they have entered into an agreement for sharing of seed viruses for the Sabin-inactivated poliovirus vaccine (Sabin-IPV) by JPRI and its commercialisation by Takeda.
Under this agreement, Takeda acquires the rights to worldwide development, manufacturing, and commercialisation of Sabin-IPV and Sabin-IPV containing combination vaccines.
Takeda will be provided with seed viruses by JPRI for Sabin-IPV as well as scientific data, information and technical know-how concerning the research, development, and manufacturing of the viruses and pay royalties based on the domestic sales of Sabin-IPV. It has also been agreed that any financial conditions in the event of manufacturing and commercialisation of the product overseas will separately be decided by negotiation of both parties.
Polio, or acute poliomyelitis, is a viral infectious disease, which is commonly referred to as infantile paralysis due to its high prevalence among children. Although live poliomyelitis vaccination has been used in the immunization, vaccine-associated paralytic poliomyelitis (VAPP) that develops in one of several million vaccine recipients is found, and an inactivated polio vaccine that does not induce VAPP is expected. Sabin-IPV is an only inactivated poliovirus vaccine by attenuated strain, and its safety and efficacy are comparable to the virulent strain-derived inactivated polio vaccine which are being used in Western countries. In addition, the production process of Sabin-IPV offers better safety than those of the virulent strain-derived inactivated one. Based on these profiles, WHO expect the early development of Sabin-IPV. On the other hand, the development of combination vaccines without increasing the number of injection is important as basic strategies for paediatric prophylactic vaccines in developed countries.
Taking these trends into consideration, Takeda would work to accelerate the development of a "quadruple vaccine" including Sabin-IPV which is a combination of the combined diphtheria, tetanus, and acellular pertussis vaccine (DTaP) that has already been developed and marketed by Takeda, with Sabin-IPV (development code: TAK-361S) for early launch in the market.
"JPRI has been manufacturing and providing live poliomyelitis vaccination from the past, and have established producing technology of Sabin-IPV, " said Dr. Bunsiti Simizu, president, JPRI. "We are anxious and eager for contributing the strategy of protection against infectious disease for children worldwide, through quadruple vaccine developed by sharing of seed virus and technical cooperation to Takeda."
"It is our great pleasure that we can now start the development of the quadruple vaccine including Sabin-IPV in partnership with JPRI," said Mr. Yasuchika Hasegawa, President of Takeda. "We are determined to work to provide the world with safer polio vaccines as soon as possible, playing a part in the WHO-led Global Polio Eradication Initiative to nullify the number of patients with paralysis caused by virulent poliovirus, while making a contribution to infectious disease prophylaxis."