Acambis plc announced that it has signed an exclusive global collaboration agreement with Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, for Acambis' ChimeriVax-West Nile vaccine, which is the leading West Nile vaccine in development.
Under the terms of the agreement, Acambis will receive an upfront payment of $10m in 2007 and would be eligible for pre- and post-marketing milestone payments of up to $70m based on product approval and sales in the US market. It would also be entitled to receive development funding and royalties on net sales of the vaccine. In addition, if the vaccine were registered in other countries, Acambis would be entitled to further post-marketing milestone payments and royalties. Acambis will continue to perform ChimeriVax-West Nile development activities, up to and including the filing of a licence application in the US.
There is currently no human vaccine for prevention and no specific treatment for West Nile virus-related disease, which is now considered endemic in North America. The US Centers for Disease Control and Prevention (CDC) has identified those aged 50 and above as being most at risk of severe West Nile virus-related disease. In the US, this population totals more than 87 million people. As of 6 November 2007, 3,265 cases of West Nile disease and 92 deaths have been recorded by the CDC in 42 US States this year.
"Having entered into this unique collaboration with one of the world's leading vaccine companies, we intend to be the first to bring a West Nile virus vaccine to market. Acambis will conduct the vaccine development, further validating our competence and capabilities in clinical development and vaccine manufacture. This contract is an important step in executing on our financing strategy for the company," said Ian Garland, chief executive officer, Acambis.
"Providing a vaccine against West Nile disease may now be within reach. This candidate vaccine is the most promising in the industry and would help meet a growing public health need," said, Wayne Pisano, president and chief executive officer, Sanofi Pasteur
Acambis is currently conducting a phase II trial of ChimeriVax-West Nile in adults aged 41-64 years and 65 years and above. Preliminary data from a previous Phase 2 dose-ranging trial in healthy adults have shown that over 98 per cent of subjects seroconverted 28 days after a single vaccination. The safety profile of the vaccine has been shown to be satisfactory. Acambis' West Nile vaccine candidate uses its proprietary ChimeriVax technology, which was developed in association with St Louis University.
West Nile virus is a potentially serious illness. Experts believe it is established as a seasonal epidemic in North America that flares up in the summer and continues into the autumn. About one in 150 people infected with West Nile virus will develop severe illness. The severe symptoms can include high fever, headache, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, vision loss, numbness and paralysis. These symptoms may last several weeks, and neurological effects may be permanent.
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 non-biodefence pipeline, has to date shown an excellent safety and efficacy profile following pivotal phase III trials. It is currently undergoing paediatric trials in India and is partnered with Sanofi Pasteur and Bharat Biotech. Acambis' proprietary ChimeriVax technology, developed in association with St Louis University, has also been used to develop ChimeriVax-West Nile, which is undergoing phase II 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 II trial by generating 100 per cent 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 350,000 cases of C. difficile-associated disease in the US alone with annual costs to the healthcare system of $1.1bn. Acambis' influenza programme aims to develop a universal vaccine against influenza, for which a universal 'A' strain vaccine, ACAM-FLU-A, is currently being tested in a Phase 1 trial, and also includes various further vaccine candidates in the research and pre-clinical stages.
Acambis is recognised internationally as the leading producer of smallpox vaccines. Acambis' ACAM2000 vaccine for active immunisation against smallpox disease for persons determined to be at high risk for smallpox infection was licensed by the US Food and Drug Administration in August 2007. Acambis has manufactured doses of ACAM2000 for emergency-use stockpiles held by the US Government and several other governments around the world.