Fighting the flu with vaccines - and fast!

Medicago Inc.

June 23, 2011— Quebec City, Quebec

First published June 23, 2011; updated August 2013

Producing vaccines to respond quickly to emerging diseases

To subdue emerging diseases, the ability to produce a vaccine quickly is critical. Traditional egg-based and cell production systems are effective, but Medicago Inc. has pioneered an innovative technology that offers speed and cost advantages over these traditional systems.

Founded in 1999, Medicago develops vaccines based on two technologies: its plant-based ProficiaTM and its Virus-Like Particles (VLPs). ProficiaTM uses living plants as hosts for vaccine production, while VLPs are vaccines that resemble viruses and are recognized by the immune system but lack the viruses’ genetic material to replicate.

Recognizing Medicago’s potential for scientific knowledge and innovation, the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) has collaborated with and provided extensive assistance to the company on several projects for its VLP and ProficiaTM technologies.

From left to right: Elizabeth Lalonde and Nicole Bechtold - Infiltration

From left to right: Elizabeth Lalonde and Nicole Bechtold - Infiltration

IRAP technical and business advisory services

Over time, Medicago has worked with many of IRAP’s Industrial Technology Advisors (ITAs), most notably, Alexandre Blais, Georges Lagacé and Pierre Trépanier. Each advisor contributed his own specific expertise and knowledge to Medicago’s projects and business strategy.

«One of our ITAs, Alexandre Blais, had extensive training in agronomy and understood very well the technology behind processing plant material. That was a great advantage since we found ourselves talking not to financial administrators, but to scientists who understand the difficulties and possibilities of the technology,» said Dr. Marc-André D’Aoust, Director of Innovative Technology at Medicago. With Blais’ assistance, NRC IRAP provided funding that helped the company secure the confidence of various other investors and eventually obtain an investment from France Luzerne.

ITA Pierre Bourassa took the baton in 1999 and introduced many potential investors to the firm. He invited and accompanied Medicago on numerous commercial missions to the U.S., France, Japan and Spain to discuss partnerships and investment. In 2004, the NRC IRAP team led by Bourassa closed a deal that helped qualify Medicago’s facilities for cGMP production (2005–2007). Another NRC IRAP project supported the development of Medicago’s first product, a VLP-based pandemic influenza vaccine.

ITA Pierre Trépanier strongly supported the use of plants to tackle the challenge of producing a rapid influenza vaccine. Vaccines can be cultured much more quickly on plants than through conventional approaches such as egg or animal cells. As the project developed, Trépanier advised the firm on the different regulatory processes, particularly on the release of vaccine lots and how to obtain the essential reagents to control them. Trépanier also provided Medicago with relevant information and data obtained from various sources confirming the company’s technological edge in the industry.

Concrete results: lower production costs, increase in productivity, creation of new jobs

Nicotiana benthamiana growing in Medicago Inc.’s production facility.

Nicotiana benthamiana growing in Medicago Inc.’s production facility.

Thanks to IRAP assistance and the advice of each ITA, Medicago has one of the lowest-cost vaccine manufacturing technologies and the shortest time required to produce a vaccine than any other company in the industry. “Our relationship with NRC IRAP has helped us move forward and we have benefited from its continued guidance and contributions,” says Andy Sheldon, President and Chief Executive Officer (CEO) of Medicago.

In 2008, Medicago’s relationship with Philip Morris International, a Fortune 100 company, grew into a $15,975,000 private placement and partnership—a significant milestone for the firm. Thanks at least in part to its long-running relationship with NRC IRAP, Medicago has experienced exceptional growth in employment in recent times, expanding from 67 employees in October 2009 to near 200 employees in October 2012.

Today, Medicago is the global leader in the plant made vaccine field. Its future will include manufacturing its own products, based on molecules to which the company owns the rights.

Updated Information

  • In 2011, Medicago:
    • Reported positive clinical results from its Phase II pandemic H5N1 influenza vaccine clinical trial and Phase I seasonal influenza trial
    • Commenced operations at its 97,000 square-foot facility in North Carolina
    • Raised over $65 million of equity with investments
  • Early in 2012, Medicago announced plans to invest approximately $4 million to enhance the capacity of its pilot production facility located in Québec City. The company expects this investment to accelerate the preclinical and clinical development timelines of future product candidates.
  • In March 2012, Medicago announced the establishment of a strategic alliance with Mitsubishi Tanabe Pharma Corporation (MTPC). The objectives are to develop and commercialize at least three new vaccines with MTPC, which will provide funding for all research and development costs. In exchange for granting licensing rights, Medicago will be entitled to receive upfront and milestone payments as well as royalties for each product to be developed under this master agreement.
  • In July 2012, Medicago announced the successful production of more than 10 million doses of H1N1 VLP influenza vaccine in one month. This accomplishment was executed under a US$21M Technology Investment Agreement with US Defence Advanced Research Projects Agency to demonstrate the scalable manufacturing of Medicago's plant-expressed VLP vaccines in the US. To achieve this goal, Medicago built in 18 months a 97,000-square-foot vaccine facility in Research Triangle Park, North Carolina.
  • On July 12, 2013, Medicago announced that it has entered into a definitive arrangement agreement with Mitsubishi Tanabe Pharma Corporation ("Mitsubishi Tanabe Pharma" or "MTPC") whereby MTPC will acquire all of the issued and outstanding common shares ("Shares") of Medicago, other than the Shares currently held by Philip Morris Investments B.V. ("PMI") an affiliate of Philip Morris International Inc. and MTPC, for $1.16 in cash per Share (the "Purchase Price"). The transaction represents a total enterprise value of approximately $357 million, including the assumption of existing indebtedness, for 100% of Medicago. Upon completion of the transaction, Medicago will be jointly owned by MTPC (60%) and PMI (40%).
“Mitsubishi Tanabe Pharma’s capabilities in biopharmaceutical research, development, and commercialization along with its financial stability offer us the ideal opportunity to realize the full potential of our platform,” Chief Executive Officer Sheldon said. ”These resources provide us the ability to foster the development of innovative vaccines with the financial stability to expand our Quebec, Canadian, U.S. and global operations."

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