Acambis deal for Japanese encephalitis vaccine

Collaboration agreement

Acambis plc has agreed a partnership worth £20 million in upfront and milestone payments with Sanofi Pasteur, the vaccines business of the Sanofi-Aventis Group, for ChimeriVax-JE, Acambis’ single-dose vaccine against Japanese encephalitis.

The Cambridge-based company granted marketing, distribution and certain manufacturing rights to ChimeriVax-JE worldwide, excluding India and the Indian subcontinent where Acambis has an existing agreement with Bharat Biotech International, and also excluding the US, for which Sanofi Pasteur has been granted an option.

Sanofi Pasteur plans to introduce the new vaccine in Europe and throughout the Asia Pacific region, with particular focus on countries where the disease is endemic, including Thailand and China.

In addition to the milestones, Acambis will receive royalties on sales and payment for the supply of bulk manufactured ChimeriVax-JE product. The company has established a large-scale manufacturing process at its facility in Canton, Massachusetts, US, from which it will supply bulk vaccine.

According to the World Health Organisation, approximately 30,000 to 50,000 people suffer from Japanese encephalitis annually, mainly in Asia. A recent epidemic of the disease in northern India and Nepal killed more than 1,000 people, most of them children.

Acambis published positive data from its pivotal Phase III safety trial in October 2006, along with highlights from the still-blinded Phase III efficacy trial. The unblinded data are due to be published within the next six weeks.

Although there are vaccines against Japanese encephalitis, these require several injections to be effective, whereas ChimeriVax-JE requires only one dose. The disease is caused by a mosquito-borne flavivirus that affects the membranes around the brain. Most infections are mild, or without apparent symptoms, but approximately one in 200 infections results in severe disease characterised by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death.

ChimeriVax-JE is a live, attenuated, injectable vaccine developed using Acambis’ proprietary ChimeriVax platform technology. ChimeriVax was developed jointly by Acambis and St Louis University and has also been used to develop vaccines against West Nile virus and dengue fever.