development & production

Commercialization of protein-based vaccines & biopharmaceuticals

Free
Message: Medicago provides corporate update

Medicago provides corporate update

posted on Jan 20, 2010 10:06AM

Medicago provides corporate update

	    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."

	    Product Pipeline

	    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.

	    Partnering Opportunities

	    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.

	    Facility Expansion

	    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.

	    About Medicago

	    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.






-30-
	    /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/
Share
New Message
Please login to post a reply