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Acambis plc announces that it has extended its ChimeriVax™-JE vaccine licensing agreement with sanofi pasteur, the vaccines division of the sanofi-aventis Group, to include India and the Indian subcontinent
CAMBRIDEGE, UK and CAMBRIDGE, MA, USA | March 20, 2008 | Acambis plc (Acambis) (LSE: ACM) announces that it has extended its ChimeriVax™-JE vaccine licensing agreement with sanofi pasteur, the vaccines division of the sanofi-aventis Group, to include India and the Indian subcontinent.
Acambis announced in February 2007 that it had granted sanofi pasteur marketing, distribution and certain manufacturing rights to Acambis' single-dose ChimeriVax™-JE vaccine against Japanese encephalitis (JE). This agreement excluded the US, India and the Indian subcontinent. Acambis had an existing agreement with Bharat Biotech International Limited (Bharat Biotech) for India and Indian subcontinent, which Acambis and Bharat Biotech have mutually agreed to terminate. Acambis has granted rights over those territories to sanofi pasteur.
Acambis will receive from sanofi pasteur an upfront payment, a milestone payment on licensure of the vaccine in India and royalties on sales in these territories. Bharat Biotech has made a significant contribution towards the development of ChimeriVax™-JE and Acambis has agreed to compensate Bharat Biotech. The net financial effect is positive for Acambis.
As with the existing agreement, Acambis will supply bulk ChimeriVax™-JE vaccine to sanofi pasteur from its Canton, MA facility.
Ian Garland, Chief Executive Officer of Acambis, said:
“This extended agreement will enable both Acambis and sanofi pasteur to benefit from a more
co-ordinated approach in the JE endemic region. ChimeriVax™-JE is an important vaccine for a devastating disease and we are keen to progress towards licensure as quickly as possible.'
According to the World Health Organization, 30,000 to 50,000 people suffer from JE annually, mainly in Asia(1). During a recent epidemic in northern India and Nepal, JE killed more than 1,000 people, most of them children(2). An estimated three billion people live in JE-endemic regions, which include India, Thailand, China, Japan and parts of Australia.
About Japanese encephalitis
JE is a disease caused by a mosquito-borne flavivirus that affects the membranes around the brain. Most JE virus infections are mild (fever and headache) or without apparent symptoms but approximately one 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 25% among those with disease symptoms. Around 50% 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.
About ChimeriVax™-JE
ChimeriVax™-JE is being developed to provide a safe, single-dose JE vaccine for travellers and those living in JE-endemic regions. It is a live, attenuated, injectable vaccine and was developed using Acambis' proprietary ChimeriVax™ technology.
About ChimeriVax™
ChimeriVax™ was developed jointly by Acambis and St Louis University. Acambis has held an exclusive worldwide licence to the technology platform from St Louis University since 1997. Using the non-structural genes that drive replication of the YF-17D vaccine virus strain, elements of the target virus are introduced to create new vaccines.
About Acambis
Acambis is a leading vaccine company developing novel vaccines that address significant unmet medical needs or substantially improve standards of care. ChimeriVax™-JE, Acambis' most advanced product in its development-stage pipeline, has to date shown an excellent safety and efficacy profile following pivotal Phase 3 trials. Acambis' proprietary ChimeriVax™ technology, developed in association with St Louis University, has also been used to develop ChimeriVax™-West Nile, which is undergoing Phase 2 clinical testing, making it the most advanced investigational vaccine against the West Nile virus. Acambis has established a global collaboration with sanofi pasteur for further development and commercialisation of the vaccine. ChimeriVax™ has also been applied to development of sanofi pasteur's tetravalent dengue vaccine, which has successfully demonstrated proof-of-concept in a Phase 2 trial by generating 100% seroconversion to all four dengue virus serotypes.
Acambis also has the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. C. difficile is estimated to cause at least 360,000 cases of C. difficile-associated disease in the US alone with annual costs to the healthcare system of $3.2bn. Acambis' influenza programme aims to develop a universal vaccine against influenza, for which a universal ‘A' strain vaccine, ACAM-FLU-A, was recently tested in a Phase 1 trial. Acambis is currently undertaking pre-clinical testing of a vaccine candidate, dl5-29, against genital herpes.
Acambis is recognised internationally as the leading producer of smallpox vaccines for emergency-use stockpiles held by the US Government and several other governments around the world. Acambis developed its ACAM2000™ smallpox vaccine under contracts with the US Government.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is listed on the London Stock Exchange (ACM). More information is available at www.acambis.com.
“Safe Harbour' statement
Statements contained within this news release may contain forward-looking comments, which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions and forward-looking references in this news release are subject to the satisfactory progress of research which is, by its very nature, unpredictable. Forward projections reflect management's best estimates based on information available at the time of issue.
SOURCE: Acambis plc |