Haemacure Corporation (TSX:HAE), a Montreal-based specialty
bio-therapeutics company, has announces the results of the fiscal year
ended October 31, 2007 and provides an update on activities.
Haemacure recorded revenues of $119,704 in fiscal 2007, as compared
to $147,134 the prior year. Revenues consisted exclusively of legacy
devices sales. Operating expenses totalled $4.0 million, up 29% from
$3.1 million the prior year. The increase is mainly attributable to the
construction of the manufacturing facility, the setting-up of a
laboratory, business development and investor relations activities,
regulatory affairs, and stock-based compensation resulting from stock
option grants. Haemacure incurred a consolidated net loss of $3.97
million in fiscal 2007, or $0.03 per share, up from a net loss of $3.01
million, or $0.08 per share, the prior year.
"I am very pleased and excited with our progress since
February 1, 2007 in restructuring and setting a new direction for the
company", said Joseph Galli, Chairman and CEO of Haemacure.
"Given the current and future competitive conditions, Haemacure is
poised to become a global, independent player with a next generation,
all-human fibrin sealant", concluded Galli.
First-Patient-In
Haemacure plans on having a first patient undergo surgery in the
planned pivotal Phase II/Phase III clinical trials for its human fibrin
sealant Hemaseel(R)HMN during the first quarter of calendar 2009. The
trials will be carried out under the IND currently open with the US FDA.
Manufacturing Strategy
Haemacure is building a small-scale manufacturing facility in
Sarasota, Florida where it will first produce its proprietary fibrin
sealant for the planned pivotal Phase II/Phase III clinical trials and
the commercial launch of the product in the United States.
The commissioning of this facility is the first stage of
Haemacure's two-stage manufacturing strategy announced last
October. The timeline for the commercial launch of the fibrin sealant
remains towards the end of 2010 or the beginning of 2011. The benefit of
this two-phase strategy is that it requires lower capital expenditures
than the original plan at the onset.
The second stage of the manufacturing strategy is to expand the
launch facility into a larger scale facility and to complete the
development of Haemacure's second product candidate, the
Hemaseel(R)Thrombin human haemostatic agent, now in pre-clinical stage.
Sample Fibrin Sealant for Evaluation
Haemacure is preparing to deliver small volumes of its proprietary
fibrin sealant shortly to potential partners or clients that have
requested sample product for evaluation in various applications. This
delivery is a first step towards Haemacure's objective of becoming
a long-term supplier of human fibrin sealant to the wound management,
regenerative medicine, drug delivery and biomaterials markets. The
fibrin sealant to be delivered is produced by Haemacure at its Montreal
laboratory.
Financing
Haemacure is financing its current activities with the net proceeds
of the $12.5 million private placement it completed in January 2007 and
will require additional financing during this fiscal year to support its
operations plan.
About Haemacure
Haemacure Corporation is a specialty bio-therapeutics company
developing high-value human therapeutic proteins for commercialization.
Haemacure's research and development effort is driven by its
proprietary plasma protein extraction technology to develop
next-generation products, including surgical hemostats. Haemacure's
lead product candidate, Hemaseel(R)HMN, is a human-derived fibrin
sealant planned to enter pivotal Phase II/Phase III clinical trials.
Haemacure's second product candidate is human thrombin, a component
of its fibrin sealant. Both candidates have applications in the
expanding bio-surgical market. Follow-on development will focus on
surgical hemostats, adhesion prevention, regenerative medicine, drug
delivery in select therapeutic areas and combinations with biomaterials.
Haemacure has discovered additional specialty proteins in one of its two
plasma fractions and seeks to advance these specialty proteins through
partnerships with pharmaceutical and biotechnology companies. Haemacure
is headquartered in Montreal (Quebec) Canada and operates offices in
Sarasota, Florida through a wholly-owned subsidiary. The Corporation is
traded under the stock symbol HAE on the TSX.
All dollar amounts set forth are in Canadian dollars, except where
otherwise stated.
For more information, visit http://www.haemacure.com or call
514/282-3350 ext. 22.
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