Medicago produces Rotavirus VLP vaccine candidate using plant-based manufacturing platform

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 production of a Rotavirus VLP vaccine candidate comprising all four structural antigens of rotavirus (VP2, VP4, VP6 and VP7) using Medicago's plant-based manufacturing platform.

Medicago also announced today that an international patent application under the Patent Cooperation Treaty (PCT) that broadly covers plant-produced Rotavirus VLPs has been filed.

"This represents the first time a fully assembled Rotavirus VLP has been produced in plants. The production of a plant-based Rotavirus VLP containing four major structural proteins is groundbreaking and offers a potential solution to the current efficacy and safety challenges faced with vaccines produced with conventional technologies. This  successfully completes the first part of our collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC) towards the development of a Rotavirus vaccine candidate," said Andy Sheldon, President and CEO of Medicago.

"VP4 and VP7 proteins are necessary for the development of an efficacious rotavirus vaccine and their successful incorporation into Rotavirus VLPs demonstrate the efficacy of our platform," said Marc-André D'Aoust, Senior Director of Research and Innovation at Medicago. "We look forward to continuing the development of our Rotavirus vaccine candidate and will conduct an immunogenicity and efficacy study in animals shortly."

Under this first agreement to develop a Rotavirus VLP vaccine target, MTPC was given the option to license the Rotavirus VLP vaccine target and assume global development, regulatory and commercialization responsibilities while Medicago was assigned eligibility to receive up to a total of C$33 million in upfront and milestone payments as well as royalties on future sales of the Rotavirus VLP product. Medicago received an upfront payment of C$3 million to begin the initial research on rotavirus.

Medicago's Master Research Collaboration Agreement with MTPC, announced in March 2012, was established to develop and commercialize at least three new vaccines with MTPC, who are providing funding for all research and development and commercialization costs. In exchange for granting licensing rights, Medicago is entitled to receive upfront and milestone payments as well as royalties for each product to be developed under this master agreement.

Rotavirus is the most common cause of severe diarrhea in infants and young children globally. The worldwide incidence of rotavirus is estimated at 125 million cases each year, and is responsible for more than 500,000 deaths annually. More than 85 percent of these deaths occur in Africa and Asia, and over two million are hospitalized each year with pronounced dehydration. Children under five years of age, especially those between six months and two years, are most vulnerable to the disease. While vaccines against rotavirus gastroenteritis are currently available and are the single prevention and control measure with the most significant impact on reducing severe disease incidence, economic barriers to access remain an issue in many developing countries.

In addition to the development of its Rotavirus VLP vaccine, Medicago's pipeline includes;

• a Phase II pandemic readiness clinical trial for its H5N1 pandemic influenza vaccine with interim data expected in the second half of 2013.
• a U.S. Phase IIa clinical trial for a quadrivalent seasonal flu vaccine with interim data expected in in the second half of 2013.
• the company is conducting ongoing GMP process development for a rabies vaccine, and research and development in the area of biosimilar products.