MONTREAL, June 16 /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 raised $7.8 million through the exercise of amended Series B warrants and broker warrants issued as part of the private placement concluded in January 2007.
"I sincerely thank our shareholders who demonstrated their strong support by exercising their warrants. We now have the financial resources to execute on all of the necessary milestones to get our fibrin sealant into the clinic in Q1-09. This financing significantly reduces the financial risk. All of our time and attention will be focused on execution and getting a green light from the FDA to enter clinical trials." said Joseph Galli, Chairman and CEO of Haemacure.
On June 4th, Haemacure began fractionating plasma in its new facility in Sarasota, Florida. It is on-schedule and on-budget to produce fibrin sealant clinical lots during Q3-08 and to file an amendment to its existing IND with the U.S. FDA during Q4-08.
Haemacure's fractionation facility is the first and only U.S.-based manufacturing facility for fibrin sealant destined for the U.S. market and this is of significant strategic value.
Fibrin Sealant Pivotal Clinical Trials
The safety of Haemacure's lead product candidate, all-human fibrin sealant, was demonstrated in past clinical trials as no serious adverse events related to the product were reported. The efficacy of the product was also significantly superior to the standard of care used in the control group.
New Preclinical Study in Adhesion Prevention
Encouraged by the positive results of the preclinical study Haemacure conducted on the efficacy of its all-human fibrin sealant in preventing the formation of post-surgical adhesions, Haemacure will sponsor a second study for the same application, in a slightly different model.
Haemacure is currently pursuing business development opportunities in six market segments where fibrin sealant has application, beyond its core haemostasis segment. These are wound management, adhesion prevention, regenerative medicine, drug delivery, in combination with biomaterials, and cosmetics. All these segments represent major growth opportunities that Haemacure will leverage.
Haemacure is pursuing strategic partnerships for the development of the proteins it has identified in one of its two plasma fractions: albumin, alpha-1 anti-trypsyn, immunoglobulin and plasminogen.
Haemacure Corporation is a specialty bio-therapeutics 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, now in preclinical stage. Follow-on development will focus on surgical hemostats, wound healing, adhesion prevention, regenerative medicine, drug delivery and combinations with biomaterials. Haemacure has discovered eleven additional specialty proteins and enzymes in one of its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure operates a manufacturing facility 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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