Healthcare Industry News: thrombin
News Release - February 13, 2009
Haemacure Restructures - Seeks Financing or Sale of the CompanyMONTREAL, Feb. 13 (Healthcare Sales & Marketing Network) - Haemacure Corporation (TSX:HAE ) announces that it has implemented cost-cutting measures in order to preserve cash. At the same time, the Company will continue to seek financing and will initiate a process intended to lead to a sale or merger of the Company.
Haemacure has been seeking financing since the third quarter of 2008. Several parties have expressed interest in an equity financing; however, this interest has not materialized into a viable financing. In light of the state of the financial markets, Haemacure believes that without operational changes its cash reserves will be exhausted before equity financing is completed, given Haemacure's operational burn rate and its previously-announced objective of getting into the clinic by mid-2009.
Haemacure has implemented the following measures, effective today:
- 12 of Haemacure's 18 employees have been placed on leave in Montreal and Sarasota, Florida;
- All major consulting agreements have been suspended;
- Joseph Galli, Chairman & CEO, and Marc Paquin, President, will both continue to work with the Company for nominal compensation; and
- The Company is undertaking measures with suppliers to restructure its obligations to them.
These restructuring measures provide the Company with a window of approximately 90 days in which to either arrange a bridge loan, obtain new financing, or to sell or merge the Company. As a result of these restructuring measures, and unless new financing is obtained, the Company will not commence the pivotal phase II/III clinical trials for its lead product candidate, an all-human fibrin sealant, as planned in mid-2009. However, the Company will continue, to the extent possible, with the preparation for these trials so that should funds become available the trials could commence without undue delay. A core team of manufacturing, quality and regulatory affairs and technical employees remains to preserve assets and support a potential sale or merger of the Company.
Haemacure's major assets are:
- an operational state-of-the-art, cGMP-designed manufacturing facility in Sarasota, Florida for the production of fibrinogen and thrombin;
- intellectual property allowing for low-cost and high-yield production of fibrinogen and thrombin;
- an open IND with the U.S. Food and Drug Administration (FDA) pertaining to its all-human fibrin sealant which, assuming funding, would enter pivotal phase II/III clinical trials this summer; and
- positive preclinical results on the use of its fibrin sealant for the prevention of the formation of postsurgical adhesion and for skin graft fixation for burn injuries.
Haemacure Corporation is a specialty biotherapeutics 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 haemostats. Haemacure's lead product candidate, Hemaseel®HMN, is a fibrin sealant. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development is focussed on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. Haemacure has identified eleven additional specialty proteins and enzymes in one if its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure is headquartered in Montreal, Canada and 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.
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