This is the first prequalification of a Japanese Encephalitis vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries. BioE also expects the pediatric indication to be prequalified by the end of the year.
Ms Mahima Datla, Managing Director, Biological E Limited said, "We are happy that our JE vaccine is the first ever WHO prequalified JE vaccine. It is an extremely important achievement for the vaccines community as our vaccine's prequalification is well in time to support GAVI's plans of introducing the JE vaccine in several developing countries."
Thomas Lingelbach, Valneva's President and Chief Executive Officer and Franck Grimaud, Valneva's President and Chief Business Officer, also commented, "We share the excitement for this great achievement and are pleased that our technology used for IXIARO® will now help introducing an excellent vaccine in countries of substantial needs." (IXIARO® is an FDA and EMA approved vaccine).
Biological E and Valneva (ex Intercell) established a partnership in 2005 for the development and commercialization of a Japanese encephalitis vaccine for endemic regions, based on Valneva's JEV technology. The vaccine, which was successfully developed under this partnership, is being marketed in India under the trade-name JEEV® and commercialization in other JE-endemic countries is planned.
Biological E has emerged as a fast growing company. It was in the news recently for entering into a five year Pentavalent supply arrangement with GAVI, for forming a Joint Venture with GlaxoSmithKline (GSK) to create a six-in-one paediatric vaccine combining GSK's IPV and BioE's pentavalent vaccine and for licensing Novartis's Phase II Typhoid Conjugate vaccine.
About Japanese Encephalitis
Japanese encephalitis is a disease caused by a flavivirus that affects the membranes around the brain. Approximately 1 in 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate can be as high as 60% among those with disease symptoms; 30% of those who survive suffer from lasting damage to the central nervous system. The severity of JE infections has been recognized by the medical community and the global health authorities have emphasized the need for routine vaccination, campaigns and travelers vaccine for endemic countries. The disease is endemic to many regions in Asia and South East Asia including in India, Bangladesh, Bhutan, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam.
About Biological E Limited
Biological E Limited is a leading Indian life sciences company established in 1953. It is a globally focused biopharmaceutical company and develops, manufactures and markets innovative vaccines and biologics that respond to health care needs worldwide. The company exports various vaccines to several countries. The company's product development efforts are driven by an internationally experienced management team and the company has several strategic partnerships with leading biotechnology and pharmaceutical companies and research institutes around the world. www.biologicale.com
About Valneva SE
Valneva is a new European biotech company focused on vaccine development and antibody discovery. It was created in 2013 through the merger between Intercell AG and Vivalis SA. Valneva's mission is to excel in both antibody discovery, and vaccine development and commercialization, either through in-house programs or in collaboration with industrial partners using innovative technologies developed by the company. Valneva generates diversified revenue from both its marketed product, a vaccine for the prevention of Japanese encephalitis (IXIARO®), commercial partnerships around a portfolio of product candidates (in-house and partnered), and licensed technology platforms (EB66® cell line, VIVA|ScreenTM antibody discovery technology, and the IC31® adjuvant) developed by Valneva that are becoming widely adopted by the biopharmaceutical industry worldwide. Headquarted in Lyon, France, the company employs approximately 350 people in France, Austria, Scotland, the United States, and Japan. The internationally experienced management team has a proven track-record across research, development, manufacturing, and commercialization www.valneva.com
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