HAE:TSX
MONTREAL, June 16 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), aMontreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, announces that it hasraised $7.8 million through the exercise of amended Series B warrants andbroker warrants issued as part of the private placement concluded in January2007.
"I sincerely thank our shareholders who demonstrated their strong supportby exercising their warrants. We now have the financial resources to executeon all of the necessary milestones to get our fibrin sealant into the clinicin Q1-09. This financing significantly reduces the financial risk. All of ourtime and attention will be focused on execution and getting a green light fromthe FDA to enter clinical trials." said Joseph Galli, Chairman and CEO ofHaemacure.
Manufacturing Facility
On June 4th, Haemacure began fractionating plasma in its new facility inSarasota, Florida. It is on-schedule and on-budget to produce fibrin sealantclinical lots during Q3-08 and to file an amendment to its existing IND withthe U.S. FDA during Q4-08.
Haemacure's fractionation facility is the first and only U.S.-basedmanufacturing facility for fibrin sealant destined for the U.S. market andthis is of significant strategic value.
Fibrin Sealant Pivotal Clinical Trials
The safety of Haemacure's lead product candidate, all-human fibrinsealant, was demonstrated in past clinical trials as no serious adverse eventsrelated to the product were reported. The efficacy of the product was alsosignificantly 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 Haemacureconducted on the efficacy of its all-human fibrin sealant in preventing theformation of post-surgical adhesions, Haemacure will sponsor a second studyfor the same application, in a slightly different model.
Market Opportunities
Haemacure is currently pursuing business development opportunities in sixmarket segments where fibrin sealant has application, beyond its corehaemostasis segment. These are wound management, adhesion prevention,regenerative medicine, drug delivery, in combination with biomaterials, andcosmetics. All these segments represent major growth opportunities thatHaemacure will leverage.
Haemacure is pursuing strategic partnerships for the development of theproteins it has identified in one of its two plasma fractions: albumin,alpha-1 anti-trypsyn, immunoglobulin and plasminogen.
About Haemacure
Haemacure Corporation is a specialty bio-therapeutics company developinghigh-value human plasma-derived protein products for commercialization.Haemacure's research and development effort is driven by its proprietaryplasma 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 IIIclinical trials during the first quarter of 2009. Haemacure's second productcandidate is thrombin, a component of its fibrin sealant, now in preclinicalstage. Follow-on development will focus on surgical hemostats, wound healing,adhesion prevention, regenerative medicine, drug delivery and combinationswith biomaterials. Haemacure has discovered eleven additional specialtyproteins and enzymes in one of its two plasma fractions and seeks to advancethese proteins and enzymes through partnerships with pharmaceutical andbiotechnology companies. Haemacure operates a manufacturing facility inSarasota, Florida through a wholly-owned subsidiary. The Corporation is tradedunder stock symbol HAE on the TSX.
Forward-looking Statements
Certain of the statements contained in this news release areforward-looking statements. Such statements, based as they are on the currentexpectations of management, inherently involve numerous risks anduncertainties, known and unknown. Some examples of known risks are: the impactof general economic conditions, general conditions in the biotech industry,changes in the regulatory environment in the jurisdictions in which Haemacuredoes business, stock market volatility, fluctuations in costs, and changes tothe competitive environment due to consolidation or otherwise. Consequently,actual future results may differ materially from the anticipated resultsexpressed in the forward-looking statements. Haemacure disclaims any intentionor obligation to update these statements.