MONTREAL, June 4 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), aMontreal-based specialty bio-therapeutics company developing high-value humanplasma-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 IIIclinical 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 of2009. 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, Chairmanand CEO of Haemacure. "The upcoming availability of clinical material willenable Haemacure to pursue its clinical plans in hemostasis and to expand into additional indications, such as adhesion prevention." concluded Mr. Galli.
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