QUEBEC CITY, March 28, 2013 /CNW/ - Medicago Inc. (TSX: MDG), 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 fourth quarter and year ended December 31,
2012. The Company's financial statements and management report are
available at www.sedar.com and at www.medicago.com.
"2012 was a significant year for Medicago as we completed multiple
strategic agreements for our plant-based vaccines. We have been
successful in attracting major players and are now opening doors to new
global opportunities," said Andy Sheldon, President and CEO of
Medicago. "These include a strategic alliance with Mitsubishi Tanabe
which includes $33 million in upfront and milestone payments, our first
commercial license agreement for influenza vaccines in China with
Philip Morris Products, as well as the successful completion of a $21
million project with U.S. Department of Defense for the production of
significantly more than 10 million doses of H1N1 influenza VLP vaccine
at our commercial-scale facility in North Carolina. In addition, we
completed a research collaboration agreement with a top 10
pharmaceutical company, a collaboration with Mitsubishi Chemical
Corporation and recently signed a $15 million non-dilutive loan with a
major pharmaceutical company with whom we are continuing discussions to
finalize a licensing agreement which may also include co-promotion
rights of Medicago vaccines in certain markets and, if successfully
concluded will result in the principal of the loan being applied as
upfront payments upon the execution of the licensing agreement."
"2013 will also prove to be an important year. We expect to report
interim pandemic readiness Phase II data for our H5N1 vaccine candidate
and Phase II clinical data for our quadrivalent seasonal candidate. We
believe that our proprietary plant-based manufacturing technology has
the potential to transform the speed and economics of vaccine
production. We will work to continue to execute potential contracts
with governments and pharmaceutical companies to roll-out our
compelling VLP vaccine technology globally," added Mr. Sheldon.
Clinical Highlights:
-
Received clearance by the U.S. Food and Drug Administration (FDA) to
initiate a Phase I clinical trial for its H5N1 avian influenza VLP
vaccine candidate. The trial is being run by the Infectious Disease
Research Institute (IDRI), a Seattle-based non-profit research
organization that is a leading developer of adjuvants used in vaccines
combating infectious disease. Results are expected in the first half of
2013.
-
Received positive results from an independent preclinical study on the
cross-protection effects of Medicago's H5N1 VLP vaccine candidate
("H5N1 VLP vaccine"). The study was conducted under the National
Institute of Allergy and Infectious Diseases' Animal Models of
Infectious Disease Program. The findings show that Medicago's vaccines
could provide broad protection against multiple influenza strains.
Corporate and Financial Highlights
-
Established a strategic alliance with Mitsubishi Tanabe Pharma
Corporation (MTPC) through the execution of a Master Research
Collaboration Agreement to develop and commercialize at least three new
vaccines. MTPC will provide funding for all research and development
costs. Medicago will be entitled to receive upfront and milestone
payments as well as royalties for each product to be developed under
this master agreement. All the development and commercialization costs
will be paid by MTPC. Under this first agreement to develop a Rotavirus
Like Particle (RLP) vaccine target, MTPC will have the option to
license the RLP vaccine target and assume global development,
regulatory and commercialization responsibilities while Medicago will
be eligible to receive up to a total of $33 million in upfront and
milestone payments as well as royalties on future sales of the RLP
product.
-
Successfully completed and earned the full US$21 million from the
Defense Advanced Research Projects Agency ("DARPA"). Medicago
demonstrated the scalable manufacturing of its plant-expressed VLP
vaccines in the U.S.A. under a Technology Investment Agreement. The
final milestone was the production of at least 10 million doses of H1N1
virus-like particle influenza vaccine candidate in one month ("rapid
fire test"). Testing confirmed that a single dose of the H1N1 VLP
influenza vaccine candidate induced protective levels of neutralizing
antibodies in an animal model.
-
Signed its first commercial license agreement for influenza vaccines in
China with Philip Morris Products. Medicago grants PMP an exclusive
license to develop, commercialize and manufacture Medicago's pandemic
and seasonal influenza vaccines for China. Medicago to receive up to
US$12 million in upfront and milestone payments as well as royalties.
-
Announced plans to invest approximately $4 million to enhance the
capacity of the pilot production facility located in Quebec City, which
is expected to accelerate preclinical and clinical development
timelines of future product candidates.
-
Successfully completed its research collaboration agreement with a top
10 global pharmaceutical company for the development of a non-influenza
VLP vaccine candidate.
-
Commenced trading on the OTCQX International under the symbol MDCGF. The
OTCQX is the premier tier of the U.S. over-the-counter marketplace,
providing a U.S. quotation opportunity to significantly broaden and
enhance Medicago's access and exposure within the U.S. market.
-
Completed the first step in a research collaboration with Cellectis
plant sciences, a U.S.-based subsidiary of Cellectis Group (Alternext:
ALCLS), to improve therapeutic proteins produced in tobacco plants.
-
Awarded a non-refundable contribution of up to $493,000 from the
National Research Council of Canada Industrial Research Assistance
Program (NRC IRAP). The funding will support the development of new
potency assays and process analytical technologies for Medicago's
pandemic and seasonal influenza VLP vaccine candidates.
-
Received $415,000 in financial support from the Quebec government and
the municipality of Quebec City to fund a feasibility study for a
unique biopharmaceutical production project.
Subsequent to year end:
-
Awarded an Indefinite Delivery / Indefinite Quantity (ID/IQ) contract
from DARPA based on Medicago having met all the technical requirement
standards for the contract and is now allowed to bid for the
manufacture and delivery of certain tobacco-produced proteins.
-
Executed a $15,000,000 loan agreement with a major Pharmaceutical
company. Medicago and its partner are continuing discussions to
finalize a licensing agreement. In such an event, Medicago will not be
required to pay interest on the loan.
-
Investissement Quebec has agreed to a three-year extension of the
maturity date of Medicago Inc.'s 2003 loan made under the BioLevier
program. Originally, the maturity date of the loan in the principal
amount of $15.3-million, was Dec. 31, 2014, and is now Dec. 31, 2017.
Under this new agreement, Medicago will be required to make minimum
annual repayments of $1.75-million, $2.5-million and $2.5-million in
2014, 2105 and 2016, respectively, with the remaining balance due on
Dec. 31, 2017.
-
Execution of a collaboration agreement with Mitsubishi Chemical Holdings
Corporation ("MCHC") to develop a next generation technology for plant
production.
Corporate Outlook
Expected upcoming milestones include:
-
Initiation of a Phase II H5N1 clinical trial for a one-dose H5N1 VLP
with interim data expected in the second half of this year.
-
Initiation of a US Phase II clinical trial for a quadrivalent seasonal
influenza vaccine with interim data expected in the second half of this
year.
-
Potential contracts (government, pharmaceutical companies).
-
Addition of new pipeline candidates.
Financial Results
The consolidated loss for the year ended December 31, 2012, was
$32,666,000 or $0.13 per basic and diluted share. This compares to a
loss of $20,992,000 or $0.12 per basic and diluted share, respectively,
for the twelve-month period ended December 31, 2011. Operating
expenses were $38,194,000 in 2012 compared to $21,382,000 in 2011. The
increase in operating expense for 2012 is mainly explained by the
increase in R&D expenses related to US expenses for the DARPA project
that was successfully completed in 2012, the preparation for the Phase
IIa clinical trial of the quadrivalent influenza seasonal vaccine, of
the preparation and beginning of the production of H5N1 pandemic
vaccine quantities for our upcoming extended phase II and of work on
our new rabies vaccine, other potential targets, and on the rotavirus
candidate as part of our collaboration with MTPC.
Fourth quarter results
The consolidated loss for the three-month period ended December 31,
2012, was $10,818,000 or $0.04 per basic and diluted share. This
compares to a loss of $6,650,000 or $0.03 per basic and diluted share
for the three-month period ended December 31, 2011. Operating expenses
were $11,139,000 in the three-month period ended December 31, 2011
compared to $6,650,000 in 2011. The increase in operating expense for
2012 is mainly explained by the fact that the net R&D expenses in the
US were $4,270,000 higher in 2012 compared to 2011. This increase is
mainly explained by the fact that the Corporation did not recognize any
amount as grant revenue from DARPA compared to $3,812,000 in 2011.
Cash and short-term investments were $11.3 million as at December 31,
2012, a decrease of $29.1 million from December 31, 2011.
As at March 28, 2013, there were 247,979,304 common shares issued and
outstanding as well as 12,686,186 stock options outstanding. Warrants
outstanding and Unit options outstanding as at March 28, 2013 are in
the aggregate of 24,455,713.
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 that 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 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.
