MONTREAL, June 4 /PRNewswire-FirstCall/ - 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 2009.
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.
SOURCE HAEMACURE CORPORATION