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- Provides Update on Seasonal and Pandemic Influenza Programs -
QUEBEC CITY, Nov. 9, 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 its
operational and financial results for the third quarter ended September
30, 2012. The Company's financial statements and management report are
available at www.sedar.com and at www.medicago.com.
"In the third quarter of 2012, we announced that we had successfully
produced significantly more than 10 million doses of H1N1 influenza VLP
vaccine at our commercial-scale facility in North Carolina and
completed the DARPA project. In addition, we announced FDA
authorization to initiate a Phase I clinical trial with IDRI for an
H5N1 VLP vaccine to explore the possibility of enhanced protection with
one dose of vaccine, continued development of the quadrivalent seasonal
flu vaccine, and signed a commercial agreement with Philip Morris
Products for influenza vaccines in China," said Andy Sheldon, President
and Chief Executive Officer of Medicago. "In 2013, we expect to see
results from at least three clinical trials, which would reinforce our
position with governments and companies to secure revenues and grant
Corporate and Financial Highlights
During the third quarter of 2012:
Announced the successful production of significantly more than 10
million does of H1N1 VLP influenza vaccine candidate in one month.
Under our agreement with the Defense Advanced Research Projects Agency
("DARPA"), this earned Medicago a US$1 million milestone payment.
Testing by a third party laboratory confirmed that a single dose of the
H1N1 VLP induced protective levels of neutralizing antibodies in an
animal model. Medicago met all milsteones and has earned the full US$21
million in DARPA milestone awards.
Medicago signed a licensing agreement with Philip Morris Products SA
("PMP"). Under the agreement, Medicago granted PMP an exclusive license
to develop, commercialize and manufacture Medicago's pandemic and
seasonal influenza vaccines for China. In addition, Medicago signed an
exclusive, worldwide license for a portfolio of plant-based protein
development technologies from PMP for $0.7 million. Medicago received
an upfront payment of US$4.5 million from PMP. In addition, Medicago
is eligible to receive development milestone payments totalling US$7.5
million, as well as royalty payments on future sales.
The Infectious Disease Research Institute ("IDRI"), a Seattle-based
non-profit research organization and Medicago announced clearance from
the U.S. Food and Drug Administration to initiate a Phase I clinical
trial for an H5N1 pandemic Influenza VLP vaccine candidate ("H5N1 VLP
vaccine"). The trial is focused on evaluating the safety and
immunogenicity of the H5N1 VLP vaccine, combined with IDRI's
Glucopyranosyl Lipid A ("GLA") adjuvant, administered intramuscularly
("IM") or intradermally ("ID"). The trial is believed to be the first
human test of an intradermal adjuvant - a technology platform that
could potentially benefit a number of worldwide vaccination programs.
The trial is funded by a multi-million dollar grant IDRI received from
DARPA to develop an influenza vaccine for pandemic flu.
Subsequent to the third quarter:
Medicago and Cellectis plant sciences, a US-based subsidiary of
Cellectis Group (Alternext: ALCLS), ("Cellectis"), a specialist in
genome engineering, successfully completed the first step in their
research collaboration to improve therapeutic proteins produced in
tobacco plants. Cellectis develops enzymes called nucleases which can
enable the production of biosimilar products.
Update on H5N1 Pandemic Influenza Program
The pandemic threat from H5N1 Avian Influenza remains a serious global
threat. Recent studies by Fouchier and Kawaoka in Science and Nature1 have demonstrated that by recombining already circulating strains,
human to human transmission is possible. These authors have also
demonstrated that five mutations are needed for human to human
transmission, and that current H5N1 strains circulating in birds are
three mutations away from becoming transmissible to humans, strongly
supporting the need for pandemic preparedness2.
Medicago is therefore expanding its H5N1 clinical program to ensure the
continued development of this best-in-class vaccine. The Company
believes that this will provide Medicago with enhanced access to future
government contracts and grants for pandemic preparedness. Government
contracts may include participation as a domestic supplier in Canada,
the U.S., as well as in Europe and Asia. Grant opportunities include
the Biomedical Advanced Research and Development Authority (BARDA)
Broad Agency Announcement for the Advanced Development of Medical
Countermeasures for Pandemic Influenza and other U.S. funding
This clinical trial is expected to start in the spring of 2013. This
trial will be designed to determine the lowest dosage possible by both
IM and ID routes and by combining the vaccine with a GLA adjuvant from
IDRI. Initial safety and immunogenicity data are expected in the
summer of 2013, with ongoing results due later in the year.
Manufacturing of the H5N1 vaccine candidate for the trial will occur at
Medicago's pilot facility in Quebec City. The trial will be designed to
demonstrate that: (1) the dosage of H5N1 vaccine can be reduced,
thereby effectively increasing capacity and reducing the cost of goods
of our pandemic vaccine; (2) Medicago's H5N1 vaccine has the capacity
to cross-protect against different strains of H5N1, an important
advantage as strains can mutate during a pandemic; and, (3) as ID
administration will be tested, this could simplify vaccine distribution
and administration during a pandemic. The Company has already shown
protection in animal models after one dose of vaccine. Medicago will
now continue to explore the possibility of enhanced protection with one
dose of vaccine in humans. Additional details will be provided at a
Update on Seasonal Influenza Vaccine Program
Medicago is currently preparing for a Phase IIa clinical trial of its
quadrivalent seasonal influenza vaccine candidate. As part of the
development of the vaccine, the Company completed different
pre-clinical studies. In two animal models, the quadrivalent VLP
vaccine was found to be safe and immunogenic, inducing antibody levels
comparable to licensed vaccines and allowing for the progression to the
production of the clinical lots. The production of the vaccine was
initially planned to occur at our pilot facility in Quebec, however the
Company has decided to transfer the production to the commercial-scale
facility in North Carolina. This transfer will provide additional
capacity at the pilot facility in Quebec, allowing for accelerated
production of H5N1 vaccine for the new clinical study, rotavirus,
rabies, and other vaccine candidates including at least two additional
targets related to Medicago's strategic alliance with Mitsubishi Tanabe
As the North Carolina facility was intended to produce the seasonal
influenza vaccine candidate for the Phase IIb clinical trial, it is
expected that there will be no impact on the projected time to market
as the transfer would have occurred later for the Phase IIb trial.
Following successful completion of Phase II and Phase III clinical
trials, Medicago anticipates that its quadrivalent seasonal influenza
vaccine would receive FDA approval in 2016. At that time, it is
estimated that the U.S. market for seasonal influenza vaccines will be
valued at US$2 billion. Technology transfer from Quebec to North
Carolina is ongoing and production has begun. Interim data from the
clinical trial is now expected to be available in summer 2013.
Interim data from IDRI Phase I clinical trial in the first quarter of
Preparation for pandemic readiness clinical trial for H5N1 pandemic
influenza vaccine with interim data expected in summer 2013; and
Preparation for US Phase IIa clinical trial for quadrivalent seasonal
influenza vaccine with interim data expected in summer 2013.
The consolidated loss for the three-month period ended September 30,
2012, was $4,748,832 or $0.02 per basic and diluted share. This
compares to a loss of $4,407,058 or $0.03 per basic and diluted share
for the three-month period ended September 30, 2011. Operating
expenses were $9,440,652 in the three-month period ended September 30,
2012, compared to $4,594,871 in the same period of 2011. The increase
in operating expense of $4,805,781 is mainly explained by: (1) the
preparation for the Phase IIa clinical trial of the quadrivalent
influenza seasonal vaccine; (2) preparation and beginning of the
production of H5N1 pandemic vaccine quantities for our upcoming
clinical trial; (3) work on our new rabies vaccine and other potential
targets; and (4) work on the rotavirus candidate as part of our
collaboration with Mitsubishi Tanabe Pharma Corporation.
Cash and short-term investments were $23.0 million as at September 30,
2012, a decrease of $17.3 million from December 31, 2011.
As at November 9, 2012, there were 247,874,006 common shares issued and
outstanding as well as 10,651,773 stock options outstanding. Warrants
outstanding and unit options outstanding as at November 9, 2012, are in
the aggregate of 24,455,713.
Medicago Inc. Interim Consolidated Statements of Income (Unaudited)
Three-month period ended September 30,
Nine-month period ended September 30,
Revenues from license
Revenues from research agreements
Research and development
General and administrative
Depreciation of property, plant and equipment
Amortization of intangible assets
Loss for the period before deferred income taxes
Deferred income taxes
Net loss for the period
Basic and diluted loss per share
Selected Balance Sheet Data (Unaudited)
Cash and short-term investments
Finance lease liability
1Horfst et al. (2012) Science336: 1534; Imai et al. (2012) Nature486: 420. 2Russell et al. (2012) Science336: 1541.
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. Such statements include but are not
limited to statements related to expected clinical development
timelines and potential government contracts and grants. 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 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.
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