Haemacure Discloses Positive Results Of a Preclinical Study of Its Fibrin Sealant in Adhesion Prevention and Opens a New Opportunity in a Market with a Significant Unmet Medical Need
MONTREAL, April 10, 2008 /CNW Telbec/ - Haemacure
Corporation (TSX : HAE), a Montreal-based specialty
bio-therapeutics company developing high-value human
plasma-derived protein products for commercialization, disclosed
today the results of a preclinical study it recently conducted
on the use of its proprietary lead product candidate, the
human fibrin sealant Hemaseel HMN, in preventing the formation
of post-surgical
adhesions.
The study was conducted on 16 rabbits that underwent open
gynaecologic surgery in a uterine horn model. In preclinical
testing, Hameacure's fibrin sealant was found to be
significantly superior to the control group in preventing the
formation of post-surgical tissue adhesion. It was also found
to be superior to historical data disclosed in published literature
for GYNECARE INTERCEED(TM)(TC7) Absorbable Adhesion Barrier,
marketed by Ethicon,
Inc.
These preclinical results are strategically significant as
Haemacure's current fibrin sealant haemostasis formulation
was used in this study. Initial analysis indicates that no
change in the formulation or the manufacturing of Haemacure's
fibrin sealant will be required to pursue an adhesion
prevention indication. The safety and manufacturing
information applicable to an IND to conduct adhesion
prevention trials using Haemacure's fibrin sealant is
identical to the information that will be included in the IND
amendment to be filed later this year for the haemostasis
indication. It is likely that adhesion prevention-specific
preclinical data, clinical protocols and programs will also
be required.
The use of Haemacure's current fibrin sealant haemostasis
formulation for adhesion prevention could significantly
accelerate time to market for this indication, by three to
five years. This reduced timeframe accelerates Haemacure's
ability to address a significant unmet medical need with an
additional indication for its fibrin sealant. Post-surgical
adhesions are estimated to cost the U.S. healthcare system in
excess of $2.1 billion annually. The U.S. market for adhesion
prevention products is estimated today at $100 million and
could grow to US$150-200 milion in fibrin
sales.
Post-surgical tissue adhesion is a significant clinical problem
within every surgical specialty. It is a disorder in which
tissues that should remain separated in the body adhere to
each other. Adhesions are a major cause of infertility, bowel
perforation, small bowel obstruction, chronic abdominal and
pelvic pain, and have been associated with patient
mortality.
Liquid fibrin sealants, such as Haemacure's, are much easier to
apply to treatment sites than adhesion barriers such as
Interceed(TM). They also lend themselves to laparoscopic
application much better than these types of
barriers.
"We are very excited with the results of this study, as it opens a
new market with a significant unmet medical need and allows
Haemacure to leverage to leverage its technology, past
clinical data and experience in a timely manner" said Joseph
Galli, Chairman and Chief Executive Officer of Haemacure.
"This initiative demonstrates our commitment to leverage our
assets, people and technology to create shareholder value and
reduce risk." concluded Mr. Galli.
About Haemacure
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 its fibrin sealant. Follow-on development will focus on surgical hemostats, wound healing, adhesion prevention, regenerative medecine, drug delivery and combinations with biomaterials. Haemacure has discovered 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.
Forward-looking Statements
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: Haemacure Corporation: Joseph Galli, Chairman and CEO, (514) 990-7074, jgalli@haemacure.ca, http://www.haemacure.com; Diane Roch, Director, Communications and Investor Relations, (514) 282-3350 ext. 27, Cell: (514) 952-3350, droch@haemacure.ca
Posted: April 2008
