AstraZeneca, a global, innovation-driven biopharmaceutical business, announced that its global biologics research and development arm, MedImmune, has entered an agreement granting Daiichi Sankyo Company, Ltd. (Daiichi Sankyo) an exclusive license to develop and commercialise FluMist Quadrivalent in Japan.
FluMist Quadrivalent is a live attenuated influenza vaccine which is administered as a nasal spray and contains four protective strains. Phase III safety and efficacy studies were conducted for FluMist Quadrivalent in Japanese children over the 2014-2015 influenza season and a regulatory submission is being prepared in Japan.
Under the terms of the agreement, Daiichi Sankyo will pay AstraZeneca an upfront fee with subsequent development milestones and sales-related payments post launch. Daiichi Sankyo will take on the full responsibility for the future development and commercialisation of FluMist Quadrivalent in Japan and will hold the marketing authorisation; AstraZeneca will supply FluMist Quadrivalent to Daiichi Sankyo.
Marc Dunoyer, chief financial officer and senior executive team member responsible for Japan, said, “We’re pleased to enter into this agreement with Daiichi Sankyo, whose specific expertise in developing and commercialising innovative vaccines will help ensure we bring FluMist Quadrivalent to as many children as possible in Japan.”
Takeshi Ogita, member of the board & head of vaccine business unit, Daiichi Sankyo, said, “We are proud to be able to deliver, once approved, FluMist Quadrivalent to Japanese children and adolescents and to make a contribution to public health by protecting people from influenza.”
The transaction reflects AstraZeneca’s business model, which includes collaborating with companies that have the expertise, focus and resources to maximise the potential of the company’s innovative medicines for the benefit of patients and shareholders. The agreement builds on the successful collaborations between AstraZeneca and Daiichi Sankyo, such as the co-commercialisation of Nexium in Japan and Movantik in the US.
FluMist Quadrivalent (US brand name)/Fluenz Tetra (EU brand name) is the most widely available quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray and contains four protective strains for the prevention of influenza. Over 150,000 people have received FluMist/Fluenz in pre-approval and post-marketing clinical studies.
FluMist was originally approved in the US in 2003 and later in other markets. Since the original approval, more than 100 million doses have been distributed around the world.
Preferential recommendations for LAIV have been adopted in the UK, Canada, Israel, Finland, Sweden (high-risk individuals) and Germany (high-risk individuals). A general recommendation for quadrivalent LAIV in people aged two to 49 has been adopted in the US.