Sanofi Pasteur has announced that it has signed an exclusive global collaboration agreement with Acambis plc, for the development and marketing of a West Nile vaccine to help fight against this serious, life-altering and potentially fatal disease.
Scientists believe that a safe and effective vaccine may prove to be the most cost-effective strategy to prevent severe West Nile virus illness.
There is currently no human vaccine for prevention and no specific treatment for West Nile disease, which emerged in the United States in the 90's and is now considered endemic in this country. As of November 6th, 3,265 cases of West Nile illness and 92 deaths have been recorded in 42 States by the U.S. Centers for Disease Control and Prevention (CDC) in 2007. The CDC has identified those aged 50 and above, which represents more than 87 million people, as being most at risk of severe West Nile virus-related disease.
"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 ealth need," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur.
Under the terms of the agreement, Acambis will continue to perform development activities, up to and including the filing of a license application in the U.S. Acambis will receive an upfront payment of US$10 million and would be eligible for pre and post-marketing milestone payments of up to US$70 million.
"Since 1999 when it was detected into the US, the West Nile virus has spread across the entire continental United States, causing 27,240 cases and 1,054 deaths," said Ian Garland, Chief Executive Officer of Acambis. "Vaccination is the ideal approach to tackling this disease and, through this unique collaboration we aim to bring this vaccine to market as rapidly as possible."
The West Nile vaccine candidate is currently in a Phase 2 clinical trial in adults aged 41-64 years and 65 years and above. Preliminary data from a previous Phase 2 trial in healthy adults have shown that over 98% of subjects developed specific antibodies in the serum 28 days after a single vaccination. The safety profile of the vaccine has been shown to be satisfactory.
According to the CDC, West Nile virus (WNV) is a potentially serious illness. Experts believe WNV is established as a seasonal epidemic in North America that flares up in the summer and continues into the fall. About one in 150 people infected with WNV 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. Up to 20 percent of the people who become infected have symptoms such as fever, headache, and body aches, nausea, vomiting, and sometimes swollen lymph glands or a skin rash on the chest, stomach and back. Symptoms can last for as short as a few days, though even healthy people have become sick for several weeks. Approximately 80 percent of people (about 4 out of 5) who are infected with WNV will not show any symptoms at all.