QUEBEC CITY, QC, Jan. 20 /CNW/ - Medicago Inc. (TSX-V: MDG), a clinical-stage biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today provided an update on ongoing corporate activities and select objectives for 2010.
"Our top priority for 2010 remains the completion of a Phase II clinical trial with our lead H5N1 pandemic vaccine candidate, accelerating the development of our seasonal vaccine candidate, as well as the execution of several agreements with countries and/or pharmaceutical companies," said Andy Sheldon, President and CEO of Medicago. "The positive results attained in our Phase I trial have allowed us to carry on discussions with our potential partners and move closer to finalizing agreements. Beyond our H5N1 vaccine candidate, the planned initiation of a Phase I/II trial for our H1N1 vaccine candidate is another important step towards advancing our products and it will allow us to fast-track our seasonal candidate. By the end of this year and with currently available cash resources, we will have three products in different stages of development and will have saved many months of development for our seasonal candidate."
Following the recent successful completion of a Phase I clinical trial with its H5N1 pandemic vaccine candidate, Medicago is now preparing a regulatory dossier which will be submitted to Health Canada in the following months. If granted approval, the Company will initiate a Phase II clinical trial in the second quarter of 2010 and results would be available in the fourth quarter of 2010.
The Company is also proceeding with preclinical studies with its H1N1 pandemic vaccine candidate and expects to file a Clinical Trial Application (CTA) in the fourth quarter of 2010 to initiate a Phase I/II clinical trial. Medicago's strategy is to take advantage of the development work that will be completed for its H1N1 pandemic vaccine candidate to bolster its safety database and apply it to potentially shorten the path of approval for its seasonal vaccine candidate. Interim clinical data from the H1N1 trial, including measurements of safety and tolerability are expected to be available by early 2011. With this data in hand and if granted approval by Health Canada, the FDA and the EMEA Medicago could potentially commence a Phase IIa clinical study with its seasonal candidate in 2011.
Medicago is actively engaged in partnering discussions for the implementation of its vaccine manufacturing technology in several countries and with large pharmaceutical companies. The Company expects that any ongoing or future out-licensing activities will be concluded during 2010, providing future sources of revenue from upfront or technology access fees, milestones payments and royalties. The Company also plans to pursue collaborative opportunities with government agencies to gain access to grants in the USA and Canada.
New applications of Medicago's technology
The Company continues to investigate new applications of its plant-based manufacturing platform beyond the biological drug market. During 2009, Medicago was awarded a proof of concept contract by the U.S. Army to investigate the affordable production of industrial enzymes in the field of biofuels. This project is ongoing and will conclude at the end of the first quarter of 2010. Conclusions from the study and potential further developments are expected in the second quarter of 2010.
Medicago has completed the expansion of its current cGMP manufacturing facility. The expansion has provided additional space to produce Phase III clinical grade material. The facility expansion includes the addition of approximately 2,500 sq. ft., of expanded purification and production capacity.
Medicago is committed to provide highly effective and affordable vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against H5N1 pandemic influenza, using a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It could deliver a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.
Forward Looking Statements
This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed on March 25, 2009 with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Medicago Inc.
For further information: For further information: Medicago, Inc., Andy Sheldon, President and CEO, (418) 658-9393 x135; Medicago Inc., Arianna Vanin, Director, Investor Relations, (418) 658-9393 x156