Haemacure was founded in 1991 and completed a CA$30 million initial public offering in June 1996 to complete the development of its fibrin sealant and certain biomaterials. Haemacure has invested in excess of $50 million to develop and patent a unique, high-yield fibrinogen and thrombin extraction technology, and intends to use its technology as a human plasma-protein product development platform.
Scale-up of the manufacturing process of Haemacure's fibrin sealant was completed in 1997 by the Central Laboratory, Blood Transfusion Service of the Swiss Red Cross (“ZLB”). ZLB also built in 1999 a manufacturing plant dedicated to this product in Bern, Switzerland. By 1999, ZLB had invested CA$22.9 million in Haemacure, making it its largest shareholder with 28% of capital and two nominees on Haemacure’s board of directors.
In September 2000, ZLB sold its plasma fractionation business and assets to CSL Ltd. (“CSL”) of Australia. Among the assets transferred to CSL were the manufacturing plant built by ZLB and the agreement then in force between Haemacure and ZLB for the long-term supply of Haemacure in commercial quantities of its fibrin sealant. A year later, CSL terminated this agreement and later dismantled the manufacturing plant. While CSL provided compensation to Haemacure for this termination, this was a very critical setback for Haemacure as it delayed the market launch of its proprietary fibrin sealant.
In June 1998, during the course of its relationship with ZLB, Haemacure began selling in the United States under license from Baxter Healthcare S.A. (“Baxter”) the very first commercial homologous fibrin sealant approved by the Food and Drug Administration (“FDA”). Haemacure thus became one of the two pioneers that undertook to develop in June 1998 the commercial homologous fibrin sealant market in the United States. Due to retail price erosion and its negative impact on its ability to meet certain financial commitments, Haemacure discontinued the sale of the product in November 2003. At that time, Haemacure had gained a near-30% share of the fibrin sealant market against Baxter. This role in developing the fibrin sealant market in the United States between June 1998 and November 2003 enabled Haemacure to develop and acquire valuable knowledge and first-hand experience in this market. This expertise will be leveraged as Haemacure brings its fibrin sealant Hemaseel HMN to market.
In March 2004, Haemacure completed a private placement of CA$5.2 million and undertook to arrange for contract manufacturing for its two product candidates. During the assessment of potential contract manufacturers, Haemacure also assessed the Hynetics® single-use bio-processing equipment, that it ultimately selected for the production of both its product candidates.
In January 2007, Haemacure completed a CA$12.5 million private placement. Two funds affiliated with New York-based Firebird Management LLC were the lead investors in the placement, for an aggregate amount of CA$2.5 million. The private placement received support from major shareholders, who also participated in the placement.
In February 2007, Mr. Joseph Galli, Chairman of Haemacure, was appointed its Chief Executive Officer.
In April 2007, Mr. Joseph A. Akers joined the Board of Directors of Haemacure. Mr. Akers was, until the beginning of 2007, President of the Bayer Healthcare Hematology and Cardiology Business Unit (formerly known as Biological Products Division).
In June 2007, Haemacure announced the preliminary findings of the content analysis of one of its two plasma fractions. The findings confirm the presence of eleven proteins and enzymes with potential application in significant markets. These findings may take a very strategic significance for Haemacure as the sales revenues eventually generated from their commercial exploitation will constitute a direct contribution to its bottom line, because the cost of plasma will be fully borne by Haemacure's current product candidates once these are commercialized.
The proteins found are albumin, A1PI, immunoglobulin and plasminogen. The enzymes found may have potential as Orphan Drugs, to treat Fabry's, Gaucher's, Hunter's, Hurler's, Morquio's, Pompe's and Schindler's diseases.
These findings are preliminary and the full value of these proteins and enzymes may not be realized without FDA approval. Haemacure seeks to develop them in collaboration with pharnaceutical and biotechnology companies.
In October 2007, Haemacure announced a two-phase stategy to have a first patient undergo surgery in the pivotal Phase II-Phase III clinical trials for its fibrin sealant during the first quarter of 2009. The first phase of the strategy consists in setting-up a small-scale manufacturing facility by mid-2008, where fibrin sealant will be produced for these clinical trials and for commercialization once approved by the FDA. The second phase consists in the expansion of the small-scale facility during the review of its Biologics Llicense Application ("BLA") by the FDA and the development of Haemacure's second product candidate. The manufacturing facility is located in Sarasota, Florida.
Haemacure has commenced producing samples of its fibrin sealant in its Montreal laboratory, for delivery to potential clients and partners for evaluation in wound management, drug delivery, regenerative medicine and combination with biomaterials applications.
In December 2007, Haemacure announced the start of construction of its small-scale facility, scheduled for completion by mid-2008. On the same date, Haemacure also announced the hiring of two senior scientists. Also on the same date, Haemacure announced that directors and officers of Haemacure purchased, directly and indirectly on the secondary market, in excess of 1 million shares of Haemacure at prices ranging from $0.12 to $0.155 per share, in compliance with securities regulations.