-First successful plant-based Rotavirus VLP containing all 4 Major
proteins-
-International Patent Application filed-
QUEBEC CITY, June 20, 2013 /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 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.
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. 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 28, 2013, 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.