Haemacure Announces Preliminary Findings of its Plasma Discard Analysis
MONTREAL, June 14, 2007 /PRNewswire-FirstCall/ Haemacure Corporation , a Montreal-based specialty biotherapeutics company, today announced the preliminary findings of the content analysis of one of its plasma discards.
Preliminary findings confirm the presence of a number of proteins and enzymes with applications in significant worldwide markets, including albumin, plasminogen, immunoglobulin and A1PI.
These findings take on a strategic significance for Haemacure as revenues eventually generated from the commercial exploitation of these proteins and enzymes will constitute a direct contribution to the bottom line. This is because the cost of the plasma will be fully borne by Haemacure's fibrin sealant and hemostatic agent once these products will be commercialized.
"We are very excited with the positive outcome of the content analysis of one of our plasma discards," said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "This is the first tangible result of our new biotherapeutics orientation that we announced at our recent meeting of shareholders. The identification of these proteins and enzymes indicates that our patented plasma protein extraction technology yields significant potential benefits superior to the traditional extraction technology. With these results in hand, and further to interest expressed by third parties in our plasma discard, we will drive towards implementing our business development strategy that encompasses partnerships with pharmaceutical and biotechnology companies." concluded Mr. Galli.
Haemacure plans on harvesting albumin from this discard and using it in the production of its fibrin sealant, representing annual cost savings estimated at more than US$500,000 at full production plant capacity. Some albumin extracted could also be available for commercialization.
According to the Marketing Research Bureau, the world plasma-derived protein market is estimated to reach US$8.5 billion by 2010. The North American market was estimated at US$2.4 billion in 2006. Immunoglobulin is the biggest selling protein in North America, with sales estimated at US$1.4 billion in 2006 in the United States alone. Immunoglobulin is used to treat immunological, neurological and other disorders. Plasminogen, once converted into plasmin, is a clot buster and offers a natural alternative to synthesized solutions to address an unmet need of the market. A1PI is used by patients suffering from hereditary emphysema resulting from A1PI deficiency. A1PI deficiency affects between 60,000 to 100,000 people in the United States.
According to Cowen and Company, enzyme replacement therapies (ERTs) will reach US$3.1B in 2011. ERTs are the cornerstone of treatment of many orphan disorders, particularly the lysosomal storage diseases. Orphan diseases are comprised of number different conditions that each afflict only a small number of individuals, but together constitute one of the most lucrative therapeutic areas. The four leading lysosomal disorder products are intended to treat Gaucher's disease, Fabry's disease, Hurler's disease and Pompe's disease.
In 2006, estimated sales for these four leading lysosomal disorder products were US$1 billion, US$359 million, US$96 million and US$30 million respectively, nearly US$1.5 billion in total. Haemacure has identified in its plasma discard enzymes each treating one of these diseases. The enzymes are alpha-galactosidase, used to treat Fabry's disease, alpha-glucosidase, used to treat Pompe's disease, beta-glucosidase, used to treat Gaucher's disease, and alpha-iduronidase, used to treat Hurler's disease.
Haemacure has also identified three other enzymes, used to treat Hunter's disease, Morquio's disease and Shindler's disease. Products are also in development for these diseases.
As advised, these findings are preliminary and the full value of these proteins and enzymes cannot be realized without FDA approval. Haemacure will continue identification work on its plasma discard and seek partnerships with pharmaceutical and biotechnology companies that would fund the development and clinical activities required to bring these proteins and enzymes to market and with which it would share sales revenues.
Haemacure Corporation is a specialty biotherapeutics company focused on developing and commercializing premium human therapeutic proteins. Haemacure utilizes its proprietary plasma protein extraction technology to develop next generation products, including hemostats for surgical use. Haemacure's lead product candidate, Hemaseel(TM)HMN, an all-human fibrin sealant, is in late stage clinical development for biosurgical applications. The second product, an all-human thrombin, a component of fibrin sealant, also has applications as a stand-alone product in the expanding biosurgical market. Follow-on development will focus on biomaterial combinations and drug delivery in select therapeutic areas. Haemacure will develop partnerships to advance specialty proteins that it has recently identified in its plasma-derived intermediates to address the unmet medical needs of patients. Haemacure also 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 Corporation 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 Corporation disclaims any intention or obligation to update these statements.
CONTACT: Joseph Galli, Chairman and CEO, Haemacure Corporation, (514)990-7074; Gilles Lemieux, Investor Relations, Haemacure Corporation, (514)282-3350 ext. 22, Cel: 514-968-1382
Ticker Symbol: (Toronto:HAE.)
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Posted: June 2007