MONTREAL, Oct. 24 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company, is pleased to announce a new two-phase strategy to have a first patient undergo surgery in the pivotal clinical trials for its lead product candidate, the Hemaseel(R)HMN fibrin sealant, during the first quarter of 2009.
This "First-Patient-In" objective is a major milestone in bringing Haemacure's lead product candidate to market. Haemacure's new two-phase strategy will greatly facilitate meeting this objective. The new strategy consists of setting-up a small-scale manufacturing facility by mid-2008, where product will be manufactured for clinical trials and commercial launch, and afterwards setting-up the large-scale facility originally planned. Both facilities will be set-up in premises currently leased by Haemacure in Florida.
Setting-up the small-scale facility requires significantly lower capital expenditures than the original plan. Haemacure will finance the first phase of its new strategy in part with existing liquidities and seek financing for manufacturing equipment.
The pivotal trials will be carried out under the existing IND currently open with the US FDA. The timeline for the commercial launch of the fibrin sealant remains the same as previously announced, towards the end of 2010.
"The benefit of this two-phase strategy is that Haemacure will not require additional equity to have a first patient in the clinic and set-up the small-scale facility", said Joseph Galli, Chairman and CEO of Haemacure.
Shipping Fibrin Sealant for Evaluation
Haemacure recently equipped and staffed a laboratory in Montreal where it has commenced producing small volumes of its fibrin sealant to respond to requests from potential partners for evaluation in various applications. Haemacure plans on commencing delivery of its sample fibrin sealant to these potential partners before the end of 2007. In addition to the bio-surgical applications of its fibrin sealant, Haemacure is positioning itself to become an exclusive, long-term supplier of fibrin sealant to the drug delivery and regenerative medicine markets.
Therapeutic Proteins and Enzymes
Haemacure is also continuing work on the content analysis of its plasma fractions and is engaged with potential partners in examining how to develop and bring these proteins and enzymes to market.
"I am extremely excited about Haemacure's prospects within our industry as well as our positioning as an up-and-coming independent player in markets expected to grow at double-digit rates over the foreseeable future. We believe that the benefits of our protein extraction technology, delivering high quality products and high production yields, will translate into significantly higher gross margins than industry average" Mr. Galli concluded.
Haemacure Corporation is a specialty biotherapeutics company developing high-value human therapeutic proteins 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 human-derived fibrin sealant in late-stage clinical development. Haemacure's second product candidate is human thrombin, a component of its fibrin sealant. Both candidates have applications in the expanding biosurgical market. Follow-on development will focus on surgical hemostats, biomaterial combinations and drug delivery in select therapeutic areas. Haemacure has discovered additional specialty proteins in its plasma-derived fraction and will advance these specialty proteins through partnerships with pharmaceutical and biotechnology companies. 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 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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