MONTREAL, June 4 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a
Montreal-based specialty bio-therapeutics company developing high-value human
plasma-derived protein products for commercialization, announces that it has
started processing plasma in its new fractionation facility for the production
of its proprietary all-human fibrin sealant for pivotal Phase II/Phase III
clinical trials, leading to commercial launch.
Haemacure has reached an important milestone this week with the
commencement of plasma fractionation in its new manufacturing facility.
Haemacure also confirms that it is on schedule and on budget to produce
clinical material during the third quarter of 2008 and file an amendment to
its existing IND with the U.S. Food and Drug Administration during the fourth
quarter of 2008, in order to begin clinical trials in the first quarter of
The new fractionation facility incorporates the Hynetics(R) single-use
bio-processing plastic containers technology, which has resulted in
significant savings in capital expenditures and will also result in
significant savings in operating costs, as compared to a stainless steel
facility. The use of this technology also minimizes the risks of
cross-contamination between production batches.
"Now that our fractionation facility is operational and that we have
started processing plasma, Haemacure is truly engaged in its transformation
from a development to a manufacturing company." said Joseph Galli, Chairman
and CEO of Haemacure. "The upcoming availability of clinical material will
enable Haemacure to pursue its clinical plans in hemostasis and to expand into
additional indications, such as adhesion prevention." concluded Mr. Galli.
Haemacure Corporation is a specialty biotherapeutics company developing
high-value human plasma-derived protein products 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 fibrin sealant to enter pivotal Phase II/Phase III
clinical trials during the first quarter of 2009. Haemacure's second product
candidate is thrombin, a component of fibrin sealant, now in preclinical
stage. Follow-on development will focus on surgical hemostats, wound healing,
adhesion prevention, regenerative medecine, drug delivery and combination with
biomaterials. Haemacure has identified eleven additional specialty proteins
and enzymes in one if its two plasma fractions and seeks to advance these
proteins and enzymes through partnerships with pharmaceutical and
biotechnology companies. Haemacure 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: Haemacure Corporation: Joseph Galli, Chairman
and CEO, (514) 990-7074, firstname.lastname@example.org; Diane Roch, Director,
Communications and Investor Relations, (514) 282-3350 ext. 27, Cel.: (514)
952-3350, email@example.com; www.haemacure.com