MONTREAL, Dec. 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 is has confirmed the successful operation qualification of the fibrin sealant production equipment at its new state-of-the-art plasma fractionation facility in Sarasota, Florida.
"I am very excited that we have achieved the important milestone of operation qualification, thus showing clear progress in our transition from a development to a manufacturing company. This allows us to take steps towards the next milestone of producing clinical lots of our lead product candidate, human fibrin sealant, and advancing it to market", said Joseph Galli, Chairman and CEO of Haemacure. "Achieving this milestone also triggers the contractual obligation of CSL Behring AG to pay Haemacure US$1.5 million", concluded Mr. Galli.
The successful operation qualification of the production equipment is one of three milestones the achievement of which obligates CSL Behring AG ("CSL") to pay to Haemacure US$4.5 million in total, pursuant to a settlement agreement entered into in 2002 in relation to its Hemaseel project. The achievement of each milestone obligates CSL to pay Haemacure US$1.5 million. As previously announced, CSL has advised Haemacure that, in its view, it is no longer obligated to make the milestone payments. Haemacure strongly disputes the position of CSL and has, as a result, filed a request for arbitration with the International Court of Arbitration of the International Chamber of Commerce to assert its right to collect the contractual milestone payments and, in particular, the payment due upon the operation qualification of production equipment. Haemacure plans on achieving the second milestone during the first half of 2009 and the third milestone during the following 12 months.
Plasma processing at the facility continues as planned and the product and production process are meeting expectations. Haemacure plans on achieving its first patient-in-the-clinic objective in the first half of 2009 and anticipates commercial launch of its fibrin sealant on the U.S. market in the first half of 2011, in line with previously announced guidance.
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 haemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. 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 is headquartered in Montreal, Canada and 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|
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