Sanofi pasteur to License Single Dose Japanese Encephalitis Vaccine From Acambis
Lyon, France (ots/PRNewswire) -
- New Vaccine Will Help Improve Public Health in Japanese Encephalitis Endemic Countries
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced today it has entered into an agreement with Acambis plc to license a single dose vaccine against Japanese encephalitis (JE), ChimeriVaxTM-JE, to help improve public health in endemic countries of Asia Pacific, including Thailand, the Philippines, Malaysia, Indonesia, China, Japan, and parts of Australia.
Approximately 30,000 to 50,000 people suffer from Japanese encephalitis annually, mainly in Asia (1). During a recent epidemic in northern India and Nepal, Japanese encephalitis killed more than 1,000 people, most of them children (2).
"Sanofi pasteur will further contribute to the fight against a devastating disease by bringing an innovative Japanese encephalitis vaccine to endemic countries. We believe a single dose vaccine will hold significant advantages for use in routine immunization programs in a region where several billion people live," said Dave Williams, Chief Executive Officer of sanofi pasteur.
Acambis has published positive data from its pivotal Phase 3 safety trial in October 2006. Clinical results show that ChimeriVaxTM-JE vaccine requires only one dose for adequate protection against Japanese encephalitis versus two to three doses required with current JE vaccines.
"ChimeriVaxTM-JE has the potential to transform the use of JE vaccines. Sanofi pasteur is a world leader in vaccines and, in our view, the best partner for ChimeriVaxTM-JE. We are looking forward to working with sanofi pasteur to ensure our vaccine reaches those who need it," said Gordon Cameron, Chief Executive Officer of Acambis.
Acambis has established a large-scale manufacturing process at its facility in Canton, MA, U.S., from which it will supply sanofi pasteur with bulk vaccine.
Under the agreement, Acambis has granted sanofi pasteur marketing, distribution and certain manufacturing rights to ChimeriVaxTM-JE worldwide excluding India and the Indian subcontinent, and the U.S. for which sanofi pasteur has an option. Sanofi pasteur plans to introduce the new vaccine throughout the Asia Pacific region with particular focus on the large endemic countries like Thailand and China. Acambis will receive upfront and milestone payments totaling up to EUR30 million following marketing authorization of ChimeriVaxTM-JE in key endemic countries and in the European Union. In addition, Acambis will receive royalties on sales and payment for the supply of bulk ChimeriVaxTM-JE product.
About Japanese encephalitis
Japanese encephalitis is a disease caused by a flavivirus that affects the membranes around the brain. Most JE virus infections are mild (fever and headache) or without apparent symptoms, but 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. In areas where the JE virus is common, encephalitis occurs mainly in young children (1).
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold more than a billion doses of vaccine in 2006, making it possible to protect more than 500 million people across the globe. The company offers the broadest range of vaccines, providing protection against 20 bacterial and viral diseases. For more information, please visit: www.sanofipasteur.com
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
(1) WHO, Water Related Disease, Japanese Encephalitis http://www.who.int/water_sanitation_health/diseases/encephalitis/en/
(2) WHO, Regional Office for South-East Asia, Immunization and Vaccine Development, Japanese Encephalitis, http://www.searo.who.int/en/section1226/section2073.asp
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