MONTREAL, April 10 /PRNewswire-FirstCall/ - 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(R)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.
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.
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.
SOURCE Haemacure Corporation