MONTREAL, April 9 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, reports on its Annual General and Special Meeting of Shareholders held this afternoon.
Results of Preclinical Study of Fibrin Sealant in Adhesion Prevention
Haemacure presented the positive results of a preclinical study it recently conducted on the use of the current formulation of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN. Haemacure's fibrin sealant proved superior to the untreated control subjects in open surgery in preventing the formation of post-surgical adhesions. It also proved to be superior to the data found in published literature for GYNECARE INTERCEED(TM) (TC7) Absorbable Adhesion Barrier, marketed by Ethicon, Inc. Haemacure plans on expanding the fields of use for its fibrin sealant by entering the adhesion prevention market, thanks to the leveraging of the current formulation of its fibrin sealant. Post-surgical adhesions are estimated to cost the U.S. healthcare system US$2.1 billion annually.
New Manufacturing Facility on Schedule and on Budget
Haemacure reported that the construction of its small scale manufacturing facility in Sarasota, Florida is progressing on schedule and on budget. The targeted completion date is mid-2008, as planned. The construction of a small-scale facility is the first phase of Haemacure's two-phase strategy to significantly reduce the cost of meeting its First-Patient-In objective during the first quarter of 2009. The second phase of the strategy consists in expanding the facility during the review of its license applications by regulatory authorities, and in completing the development of Haemacure's second product candidate, the Hemaseel(R)Thrombin active hemostatic agent. Haemacure's fibrin sealant for adhesion prevention will also be manufactured in this facility.
Haemacure announced the hiring of a Director of Manufacturing and a Director of Quality Assurance and Quality Control. This brings to five the number of senior managers Haemacure has hired since the fall of 2007.
"We have made tremendous progress since we re-started Haemacure 14
months ago. We are on track to having a manufacturing facility online
mid-2008 and having a first patient undergo surgery in our pivotal Phase
II/Phase III clinical trials during the first quarter of 2009. We are also
now able to attract high-calibre senior managers from the plasma
fractionation industry." said Joseph Galli, Chairman and Chief Executive
Officer of Haemacure. "We are confident we will deliver on the objectives
we had set for ourselves when we refinanced Haemacure, including leveraging
our assets in fields such as adhesion prevention. We look forward to making
Haemacure a fully independent global haemostasis player.", concluded Mr.
Haemacure also highlighted key milestones to be achieved in the next
- Completion of the manufacturing facility by mid-2008
- Production of fibrin sealant for pivotal Phase II/and Phase III
clinical trials by Q3/08
- Approval of amendment of IND by the US FDA to launch clinical trials
for fibrin sealant
- Launch of clinical trials in Q1/09
- Entering into of partnerships and collaborations
Board of Directors
Haemacure announced that the shareholders elected the seven nominees for election as directors.
Shareholder Rights Plan
At the annual meeting of shareholders of the Corporation, the shareholders approved the renewal of the Shareholders Rights Plan. The Plan provides for the equal treatment of all shareholders of the Corporation.
The Rights are designed to provide additional protection against abusive takeover tactics such as partial tender offers, selective open-market purchases and offers for all the shares of the Corporation at less than full value or at an inappropriate time. The Rights are intended to assure that the Board of Directors has the ability to protect shareholders and the Corporation if attempts are made to gain control of the Corporation in a manner that is not in the best interests of the Corporation and all of its shareholders.
The approved continuation of the Corporation's Rights Plan means that all common shares of the Corporation issued or to be issued will be accompanied by one Right. The Rights will be exercisable only if a person or group acquires 20% or more of the Corporation's common shares or announces an offer not in accordance with certain requirements, the consummation of which would result in the ownership by a person or group of 20% or more of the common shares. Upon a person or group owning 20% or more of the Corporation's common shares, each shareholder will be entitled to purchase, for each common share of the Corporation he or she may have, and at the Right's exercise price, a number of common shares of the Corporation having a market value at the time of twice the Right's exercise price. The exercise price is set at $100 and may be adjusted, depending on certain circumstances. Unless continued, the Plan will expire on April 26, 2011.
A replay of Haemacure's Annual General and Special Meeting of Shareholders is available on the Company's website at http://www.haemacure.com.
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 hemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first quarter of 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant. Follow-on development will focus on surgical hemostats, wound healing, adhesion prevention, regenerative medecine, drug delivery and combinations with biomaterials. Haemacure has discovered 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 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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