Influenza is a contagious respiratory illness that can cause mild to severe illness, and at times can lead to death. The Centers for Disease Control and Prevention ("CDC") states that the best way to prevent seasonal flu is by getting a seasonal flu vaccination each year. According to CDC, each year in the United States on average, 5% to 20% of the population gets the flu; on average, more than 200,000 people are hospitalized from flu-related complications, and; about 36,000 people die from flu-related causes. Some people, such as elderly people, young children, and people with certain health conditions, are at high risk for serious flu complications. According to Datamonitor, global market projections of seasonal influenza are expected to increase from $2.8 billion in 2008/2009 to $6.3 billion in 2018/2019.
In the second quarter of 2009, Medicago successfully expressed a new VLP antigen (H1 VLP) from the influenza A (H1N1) strain that caused the recent influenza outbreak in North America and other countries. The antigen was expressed within 14 days of receiving the DNA sequence, with the Company's VLP vaccine and Proficia manufacturing technologies.
The Company has also received positive results from an immunogenicity study in mice with this new vaccine candidate for the influenza A (H1N1) virus, also known as swine flu. Results demonstrated that the Company's H1 VLP vaccine induced a positive immune response in 100 per cent of the mice against the H1N1 influenza A/California/04/09 virus.
In a continuation of this study, the Company has achieved additional positive results. Results showed that a single dose of five micrograms induced a positive immune response against a new emerging strain of this virus in 100 per cent of vaccinated animals. Medicago's H1N1 VLP vaccine was formulated to protect against the Influenza A/California/04/09 virus, which was one of the original viral strains selected by the World Health Organization (WHO) for vaccine manufacturers. In this study, Medicago tested the immune response of its H1N1 vaccine against the California/07 virus and showed positive immune response after a single dose of five micrograms.
In June 2011, the Company completed its U.S. phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial. All vaccine doses were found to be safe, well tolerated and also induced a solid immune response that met the CHMP criteria, even with a single dose of 5 µg. Based on these results and subject to regulatory approval, Medicago intends to proceed with a U.S. Phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.