MONTREAL, Oct. 24 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a
Montreal-based specialty bio-therapeutics company, is pleased to announce a
new two-phase strategy to have a first patient undergo surgery in the pivotal
clinical trials for its lead product candidate, the Hemaseel(R)HMN fibrin
sealant, during the first quarter of 2009.
This "First-Patient-In" objective is a major milestone in bringing
Haemacure's lead product candidate to market. Haemacure's new two-phase
strategy will greatly facilitate meeting this objective. The new strategy
consists of setting-up a small-scale manufacturing facility by mid-2008, where
product will be manufactured for clinical trials and commercial launch, and
afterwards setting-up the large-scale facility originally planned. Both
facilities will be set-up in premises currently leased by Haemacure in
Setting-up the small-scale facility requires significantly lower capital
expenditures than the original plan. Haemacure will finance the first phase of
its new strategy in part with existing liquidities and seek financing for
The pivotal trials will be carried out under the existing IND currently
open with the US FDA. The timeline for the commercial launch of the fibrin
sealant remains the same as previously announced, towards the end of 2010.
"The benefit of this two-phase strategy is that Haemacure will not
require additional equity to have a first patient in the clinic and set-up the
small-scale facility", said Joseph Galli, Chairman and CEO of Haemacure.
Shipping Fibrin Sealant for Evaluation
Haemacure recently equipped and staffed a laboratory in Montreal where it
has commenced producing small volumes of its fibrin sealant to respond to
requests from potential partners for evaluation in various applications.
Haemacure plans on commencing delivery of its sample fibrin sealant to these
potential partners before the end of 2007. In addition to the bio-surgical
applications of its fibrin sealant, Haemacure is positioning itself to become
an exclusive, long-term supplier of fibrin sealant to the drug delivery and
regenerative medicine markets.
Therapeutic Proteins and Enzymes
Haemacure is also continuing work on the content analysis of its plasma
fractions and is engaged with potential partners in examining how to develop
and bring these proteins and enzymes to market.
"I am extremely excited about Haemacure's prospects within our industry
as well as our positioning as an up-and-coming independent player in markets
expected to grow at double-digit rates over the foreseeable future. We believe
that the benefits of our protein extraction technology, delivering high
quality products and high production yields, will translate into significantly
higher gross margins than industry average" Mr. Galli concluded.
Haemacure Corporation is a specialty biotherapeutics 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 in late-stage clinical development. Haemacure's
second product candidate is human thrombin, a component of its fibrin sealant.
Both candidates have applications in the expanding biosurgical market.
Follow-on development will focus on surgical hemostats, biomaterial
combinations and drug delivery in select therapeutic areas. Haemacure has
discovered additional specialty proteins in its plasma-derived fraction and
will advance these specialty proteins through partnerships with pharmaceutical
and biotechnology companies. Haemacure also operates offices in Sarasota,
Florida through a wholly-owned subsidiary. The Corporation is traded under
stock symbol HAE on the TSX.
Certain of the statements contained in this news release are
forward-looking statements. Such statements, based as they are on the current
expectations of management, inherently involve numerous risks and
uncertainties, known and unknown. Some examples of known risks are: the impact
of general economic conditions, general conditions in the biotech industry,
changes in the regulatory environment in the jurisdictions in which Haemacure
does business, stock market volatility, fluctuations in costs, and changes to
the competitive environment due to consolidation or otherwise. Consequently,
actual future results may differ materially from the anticipated results
expressed in the forward-looking statements. Haemacure disclaims any intention
or obligation to update these statements.
For further information:
For further information: Joseph Galli, Chairman and CEO, Haemacure
Corporation, (514) 990-7074, firstname.lastname@example.org; Gilles Lemieux, Investor
Relations, Haemacure Corporation, (514) 282-3350, ext. 22,