Medicago Successfully Completes the Production of More Than Ten Million Doses of H1N1 VLP Influenza Vaccine in One Month
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,
As part of the rapid fire test, production of the H1N1 VLP influenza
vaccine candidate began on March 25(th), 2012, and was completed in 30 days on April 24(th), 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
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.
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.