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Medicago, Inc. Successfully Completes the Production of More Than Ten Million Doses of H1N1 VLP Influenza Vaccine in One Month


7/24/2012 11:54:18 AM

DURHAM, NC and QUEBEC CITY, QC, July 24, 2012 /PRNewswire/ - Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced the successful completion of a key milestone under an agreement with the Defense Advanced Research Projects Agency (DARPA). The milestone was the production of at least 10 million doses of H1N1 VLP influenza vaccine candidate in one month ("rapid fire test"). This rapid fire test was conducted at Medicago's facility in Durham, North Carolina.

As part of the rapid fire test, production of the H1N1 VLP influenza vaccine candidate began on March 25th, 2012, and was completed in 30 days on April 24th, 2012. The production lots were then tested by a third party laboratory to confirm both the immunogenicity of the vaccine candidate and the number of doses produced. Testing confirmed that a single dose of the H1N1 VLP influenza vaccine candidate induced protective levels of neutralizing antibodies in an animal model. Significantly more than 10 million doses, as defined by the testing conditions, were confirmed.

"The completion of the rapid fire test marks a substantial achievement in demonstrating our technology and the potential for Medicago to be the first responder in the event of a pandemic flu outbreak," said Andy Sheldon, Chief Executive Officer of Medicago. "We look forward to continuing to move our company closer to commercial capability in the near future."

The rapid fire test is the fifth milestone under a Technology Investment Agreement with DARPA to demonstrate the scalable manufacturing of Medicago's plant-expressed VLP vaccines in the U.S.A. To date, Medicago has received US$19.8 million in milestone payments from DARPA for this project, and expects to receive the fifth milestone payment of US$1.0 million in the near future.

"All of the milestones in the DARPA agreement were rigorous and challenging. Production of significantly more than 10 million doses in 30 calendar days was the key milestone in terms of demonstrating Medicago's capability to meet critical unmet needs in the area of pandemic flu response. Reaching this goal is also a testament to our experienced and dedicated North American team," said Mike Wanner, Executive Vice President Operations. "Our outside partnerships were also instrumental in helping meet this milestone, including Alexandria Real Estate and the State of North Carolina."

Medicago previously signed a US$21 million Technology Investment Agreement with DARPA to develop a 97,000-square-foot vaccine facility in Research Triangle Park (RTP), North Carolina. This state of-the-art facility is a large, cost-effective and scaled-up facility for Medicago's VLP plant-based vaccine technology, ultimately for the delivery of current good manufacturing practice (cGMP)-grade vaccine. This DARPA project is part of the Blue Angel influenza vaccine rapid response demonstration program which seeks to identify new ways to produce large amounts of high quality vaccine grade protein in less than 3 months in response to emerging and novel biologic threats.

Medicago's pipeline includes the initiation of a U.S. Phase IIa clinical trial for a quadrivalent seasonal flu vaccine with interim data expected in the first quarter of 2013. A Phase I clinical trial for a one-dose H5N1 VLP vaccine with a new adjuvant is planned in partnership with the Infectious Disease Research Institute (IDRI), with interim data expected in the second half of this year. GMP process development and a GLP toxicology study for a rabies vaccine are ongoing. Medicago is also working with Mitsubishi Tanabe Pharma under a strategic alliance to develop a vaccine for rotavirus, and at least two additional vaccine candidates. In addition to vaccines, Medicago is conducting research and development in the area of biosimilar products.

About Medicago

Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one 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, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements

This news release includes certain forward-looking statements or forward-looking information for the purposes of applicable securities laws and such statements and information 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. Such statements include but are not limited to statements about the DARPA project, achievement of milestones and financial payments related to the DARPA project, and statements related to the potential for the commercial-scale facility in North Carolina. 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 "Risk Factors and Uncertainties" in Medicago's Annual Information Form filed on March 29, 2012, 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.

SOURCE Medicago Inc.



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