Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Medicago Inc. (TSX: MDG) a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced it has received Food and Drug Administration ("FDA") clearance for its phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States. The Company plans to initiate this trial within the coming weeks. This phase I trial will lead into Medicago's U.S. phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains which the Company plans to conduct later in 2011.

"Securing FDA approval to conduct this U.S. trial is a significant milestone in the advancement of our seasonal influenza vaccine," said Andy Sheldon, President and CEO of Medicago. "Our recent positive phase II interim results for our avian influenza vaccine have demonstrated to date the safety and immunogenicity of our vaccine manufacturing platform and provide us solid support for the development of our seasonal vaccine candidate. In addition, our ability to rapidly and cost-effectively produce quality vaccines is a key advantage over traditional methods and will allow us to participate in the $2.8 billion seasonal market which is expected to grow to $6.3 billion by 2019."

The Phase 1, randomized, double-blind, multicenter, active- and placebo-controlled dose-ranging study will evaluate the safety, tolerability and immunogenicity of a single non-adjuvanted dose of the H1N1 vaccine in 100 healthy adults 18-49 years of age. The subjects will be randomized to receive one of the following; an injection of the placebo, Medicago's H1N1 vaccine or an H1N1 vaccine from a licensed trivalent vaccine. The primary safety and immunogenicity results are expected within 3 months of the start of this study. These data will support the development of the Company's seasonal influenza VLP vaccine in the United States.

"Looking ahead, 2011 should prove to be an eventful year. We plan to have completed a phase II trial for our H5N1 vaccine, completed a U.S. phase I trial for our H1N1 vaccine, begun a U.S. phase IIa trial for seasonal vaccine and have a fully operational U.S. commercial grade vaccine production facility which will have the capacity to produce more than 40 million seasonal vaccine doses per year," added Mr. Sheldon.