Press Release Approval of a Cell Culture Pandemic Influenza Vaccine (H5N1) March 24th, 2014 The Chemo-Sero-Therapeutic Research Institute (Head Office: Kumamoto, President: Seiji Miyamoto, hereinafter “Kaketsuken”), announced the marketing approval of a prophylactic pandemic influenza vaccine (Emulsion Cell Culture HA Pandemic Influenza Vaccine (H5N1), hereinafter “ the Vaccine ” ) today. The Vaccine was developed in partnership with GlaxoSmithKline KK (Head Office: Shibuya-ku Tokyo, President: Philippe Fauchet), and GlaxoSmithKline Vaccines ∗ (Belgium, hereinafter“GSK”). Combining the EB66Ⓡ cell line licensed from Valneva SE (France), GSK and Kaketsuken cell culture and purification technology, and GSK adjuvant technology, clinical trials seeking to confirm safety and efficacy of the Vaccine began in March 2011, followed by a submission for manufacturing approval in March 2013, and today’s approval. In July 2012, the Vaccine was designated orphan drug status. Pandemic influenza outbreaks cannot be predicted. However, in case of an outbreak, there will be an urgent need for the rapid manufacture and supply of vaccines. The cell culture method allows the manufacturing time for pandemic influenza vaccines to be greatly reduced for rapid supply. Kaketsuken was selected for the first and second open calls of the “Development and Production System Installation Project for Cell Culture-based Pandemic Influenza Vaccine”, established by the Ministry of Health, Labour and Welfare and, as such, has received monetary support for the establishment of pandemic influenza vaccine manufacturing facilities and clinical trials. About Kaketsuken: Kaketsuken is a Japanese pharmaceutical manufacturer, involved in the development and supply of vaccines and blood plasma products. Kaketsuken has developed many pharmaceuticals for supply to the Japanese market, including influenza vaccines, a DPT/IPV combined vaccine, and a Japanese encephalitis vaccine. Kaketsuken’s goal is to contribute to human health and wellbeing, and this approval provides an opportunity for the development of vaccines against untreatable infectious diseases. ∗ Registered as GlaxoSmithKline Biologicals S.A. Media Contact: Public Relations & Compliance Affairs Division, Corporate Administration Department, Kaketsuken +81-96-344-1385 Reference As part of the national response to pandemic influenza, Kaketsuken performed clinical trials on an Egg culture H5N1 (pre) pandemic influenza vaccine in 2004, and received manufacturing approval on October 27, 2010. Kaketsuken also has experience producing vaccines against the H1N1 pandemic influenza during the 2009 outbreak. With vast experience in the manufacture and supply of influenza vaccines, and the development of adjuvants, GSK received manufacturing approval for an Egg culture H5N1 (pre) pandemic vaccine in all 27 nations of the EU in 2008, followed by approval in the US in November, 2013. The EB66Ⓡ cells used to develop the Vaccine were established using Valneva SE technology, and exclusively licensed to GSK for influenza vaccine development and sub-licensed to Kaketsuken. EB66Ⓡ cells allow for serum free suspension culture, and can be used to manufacture highly effective human and animal vaccines. The Vaccine must be used in accordance with the “Governmental plan for measures for pandemic influenza” and “guidelines for measures against pandemic influenza”.