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Haemacure Corporation
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Haemacure Appoints Thomas J. Lynch, J.D., Ph.D. to Board of Directors
www.prnewswire.com
Former FDA Deputy Director and Talecris executive adds extensive clinical, regulatory and manufacturing experience to Company's Board TSX: HAE MONTREAL, Oct. 1 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX: HAE) announced today the appointment of Thomas J. Lynch, J.D., Ph.D.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/10-01-2008/0004895512&EDATE=
Haemacure reports positive results of fibrin sealant preclinical study
www.pharmaceutical-business-review.com | Apr 11, 2008
Haemacure has announced encouraging preclinical results of the companys lead product candidate, the human fibrin sealant Hemaseel HMN, in preventing the formation of post-surgical adhesions.
Datamonitor - Haemacure reports positive results of fibrin sealant preclinical study - News
Haemacure has announced encouraging preclinical results of the company's lead product candidate, the human fibrin sealant Hemaseel HMN, in preventing the formation of post-surgical adhesions. The study was conducted on 16 rabbits that underwent open gynaecologic surgery in a uterine horn model.
PharmaLive: Haemacure Raises $7.8 Million and is Fully Funded Beyond First-Patient-In-Clinic
MONTREAL, June 16, 2008 /PRNewswire-FirstCall/ - Haemacure Corporation , a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, announces that it has raised $7.
http://www.pharmalive.com/News/index.cfm?articleid=549296&categoryid=36,61
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Haemacure Corporation
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Haemacure - A strong force in a growing industry
Haemacure Corporation is a Canada-based company focused on the development and commercialization of its proprietary and licensed bio surgical adhesives, biomaterials and surgical devices for use in a broad range of surgical applications.
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Presentation at BioContact Québec 2008 - Zibb.com
MONTREAL, Sep. 25, 2008 (Canada NewsWire via COMTEX) --
HAE:TSX
Haemacure Corporation (TSX:HAE), a specialty bio-therapeutics company developing high-value human proteins, announces that Mr. Joseph Galli, Chairman and Chief Executive Officer, will be presenting at BioContact Québec 2008. Mr. Galli will present a corporate progress report, including an update on the Company's lead product candidate, Hemaseel(R)HMN (fibrin sealant). The Haemacure presentation is scheduled to begin at 16:30 p.m. local time on Wednesday, October 1st in the Bellevue Room at the Château Frontenac in Quebec City.
Information about BioContact Québec 2008 is available at www.biocontact.qc.ca.
About Haemacure
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 planned to enter pivotal Phase II/Phase III clinical trials during the first half of 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of its fibrin sealant in adhesion prevention, aesthetics, combination with biomaterials, drug delivery, regenerative medicine, skin graft fixation for burn injuries and wound management. 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 is headquartered in Montreal, Quebec and operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX.
Forward-looking Statements
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
Haemacure Corporation: Joseph Galli, Chairman and CEO, (514) 990-7074, jgalli@haemacure.ca, www.haemacure.com; Gilles Lemieux, Secretary, (514) 282-3350 ext. 22, ir@haemacure.ca, www.haemacure.com
Tags: biotechnology business ceo clinical corporate environment florida local medicine montreal pharmaceuticals products quebec research and development technology
Companies: Haemacure Corporation (HAE), Haemacure Corporation (HAEUF)
Haemacure Appoints Thomas J. Lynch, J.D., Ph.D. to Board of Directors - Zibb.com
MONTREAL, Oct 01, 2008 /PRNewswire-FirstCall via COMTEX/ --
Former FDA Deputy Director and Talecris executive adds extensive
clinical, regulatory and manufacturing experience to Company's Board
TSX: HAE
Haemacure Corporation (TSX: HAE) announced today the appointment of Thomas J. Lynch, J.D., Ph.D. to the Company's Board of Directors. Dr. Lynch, former Deputy Director, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), currently serves as Senior Vice President Compliance, Regulatory Affairs and Public Policy for Talecris Biotherapeutics.
"Dr. Lynch brings extensive clinical, regulatory and manufacturing experience in the area of blood products and a broad strategic perspective to our Board of Directors. We are pleased to welcome him as an independent director," said Joseph Galli, Haemacure's Chairman and Chief Executive Officer. "Thomas' distinguished background and relevant expertise will be a valuable addition to our Board as we continue to make progress toward initiating a pivotal Phase II/III clinical trial for our lead product candidate, Hemaseel(R)HMN (fibrin sealant), for biosurgical hemostasis" concluded Mr. Galli.
From 2003-2005, Dr. Lynch served as Vice President, Regulatory Affairs and Quality Assurance at CryoLife, Inc., a manufacturer of medical tissues, heart valves and oncology drugs, where he was responsible for, among other things, ensuring compliance with domestic and international laws, regulations, governing the design, manufacture, and distribution of medical devices, biological products and human tissues. Prior to joining CryoLife, Dr. Lynch served as Senior Vice President, Regulatory Affairs and Quality Assurance at Clearant Inc., a biotechnology company developing pathogen inactivation technology for the biological products market. Dr. Lynch also served as Deputy Director, Division of Hematology, Office of Blood Research and Review, CBER at the FDA, a forty five-member Division engaged in research and regulatory activities related to investigational new drugs and licensing of transfusable blood components, purified plasma-derived proteins and their recombinant analogues.
Prior to the FDA, Dr. Lynch has had about 15 years experience as a research scientist in various capacities in the public, academic and private sectors; his primary scientific interests have been in the areas of protein chemistry and enzymology.
Dr. Lynch received his Bachelor of Arts degree in biology from American International College and his Masters in biology from Clark University. Dr. Lynch received his Ph.D. in biology from Wayne State University and his J.D. from Georgetown University Law Center, where he graduated cum laude.
About Haemacure
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 half of 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of its fibrin sealant in adhesion prevention, aesthetics, combination with biomaterials, drug delivery, regenerative medicine, skin graft fixation for burn injuries and wound management. 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 is headquartered in Montreal, Quebec and operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX.
Forward-looking Statements
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
Tags: academic biology biotechnology business ceo clinical college drugs environment executive fda florida law manufacturer manufacturing market medical medicine montreal pharmaceuticals president products public policy quebec regulations research research and development science technology trial university
Companies: Haemacure Corporation (HAE), Haemacure Corporation (HAEUF)
Adhesion Prevention New Major Market Opportunity, Haemacure Confirms Effectiveness of its Fibrin
MONTREAL, Sept 11, 2008 /PRNewswire-FirstCall via COMTEX/ --
HAE:TSX
Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, disclosed today the positive results of a second preclinical study conducted on the use of its proprietary lead product candidate, the human fibrin sealant Hemaseel(R)HMN, in preventing the formation of post-surgical adhesions in a bleeding surgical model.
The study compared Haemacure's fibrin sealant to untreated controls, and to two major FDA-approved adhesion prevention products: Interceed(TM) Absorbable Adhesion Barrier (Ethicon) and Seprafilm(R) Adhesion Barrier (Genzyme). Use of Haemacure's fibrin sealant in the presence of blood resulted in a statistically significant reduction in the incidence, extent and severity of adhesions, as compared to the untreated control group. Haemacure's fibrin sealant also was statistically significantly more effective than both Interceed and Seprafilm. For example, the extent of adhesions in both the untreated and Seprafilm groups was three times (54.2%) that in the Haemacure's fibrin sealant group (18%). It was even higher, four times, in the Interceed group (71.7%). Liquid fibrin sealants, such as Haemacure's, are much easier to apply to treatment sites than adhesion barriers such as Interceed. They also lend themselves to laparoscopic application much better than these types of barriers.
This second study, conducted in July 2008, confirms and extends previous pre-clinical results demonstrating the effectiveness of Haemacure's fibrin sealant in adhesion prevention, using its current haemostasis formulation. The previous study, conducted in April 2008, also demonstrated that the use of Haemacure's fibrin sealant resulted in a statistically significant reduction in the incidence, extent and severity of adhesions, as compared to untreated controls. Both studies were designed to evaluate the efficacy of Haemacure's fibrin sealant in a rabbit uterine horn abrasion model. The previous study used a model where bleeding was absent or minimal.
"We are very excited with the results of this latest study, as it opens a new market with a significant unmet medical need and allows Haemacure to leverage its technology, past clinical data and experience in a timely manner", said Joseph Galli, Chairman and CEO of Haemacure.
The use of Haemacure's current fibrin sealant haemostasis formulation for adhesion prevention could significantly accelerate time to market for this indication, by three to five years. This reduced timeframe accelerates Haemacure's ability to address a significant unmet medical need with a potential additional indication for its fibrin sealant. Post-surgical adhesions are estimated to cost the U.S. healthcare system in excess of $2.1 billion annually. The U.S. market for adhesion prevention products in gynaecological surgery is estimated today at $100 million and could grow to US$150-$200 million in fibrin sealant sales.
About Haemacure
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(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus 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.
Forward-looking Statements
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
Tags: biotechnology business canada ceo clinical environment florida healthcare market medical montreal pharmaceuticals products research and development sales surgery technology
Companies: Haemacure Corporation (HAE), Haemacure Corporation (HAEUF)
Haemacure Provides Update on Fibrin Sealant Project and Reports Third Quarter Results - Zibb.com
MONTREAL, Sept 02, 2008 /PRNewswire-FirstCall via COMTEX/ --
HAE:TSX
Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, provides an activity update and reports third quarter results.
Fibrin Sealant Project - Hemaseel(R)HMN
During the third quarter, Haemacure completed the construction phase of its manufacturing facility, started processing plasma and began the validation of the facility. In June, Haemacure raised $7.8 million of equity through the exercise of warrants issued as part of the private placement completed in January 2007. Haemacure has also begun clinical sites visits and, with feedback from surgeons, is finalizing the protocol for the pivotal Phase II/Phase III clinical trials for its fibrin sealant. A partnership and collaboration strategy has been developed and the company is pursuing various options. Haemacure is also pursuing follow-on development activities aiming to expand the use of its lead product candidate, human fibrin sealant, beyond its primary haemostatic and tissue sealant function.
Plasma processing is proceeding as planned and the product and production process are meeting expectations. The validation and documentation phase has proven more time and resource consuming than planned and Haemacure will require more time to complete this phase. Additional resources are being deployed to complete this phase and Haemacure expects that this delay will move its first patient-in-the-clinic milestone by one quarter to calendar H1 2009 rather than Q1 2009. Haemacure anticipates commercial launch of the product on the U.S. market at the beginning of 2011, in line with the Corporation's previously announced guidance.
"I am very pleased with the progress we have made towards reaching our goal of a commercial launch at the beginning of 2011. Haemacure's platform extraction technology will provide very competitive advantages in terms of fibrin sealant performance and cost, and will be exploited in the only fibrin sealant manufacturing facility based in the United States for the U.S. market." said Joseph Galli, Chairman and CEO of Haemacure. "Concurrent with getting back into the clinic, we are focussing our efforts on partnering for the growing potential applications for our fibrin sealant. I look forward to an exciting next 12 months as we enter late stage clinical trials and partnering phases," concluded Mr. Galli.
Third Quarter Results
Revenues amounted to $25,593, as compared to $31,674 for the same quarter last year. Revenues are exclusively derived from the sale of legacy fibrin sealant application devices. The fluctuations in sales are mainly the result of changes in the Canadian/US dollar exchange rate. Operating expenses amounted to $2.0 million, as compared to $869,822 for the same quarter last year. The increase is mainly attributable to salaries and benefits resulting from the hiring of personnel, the purchase of supplies and raw material to begin plasma fractionation to produce fibrin sealant, and clinical trials-related activities.
Financial Position
Cash, cash equivalents and temporary investments amounted to $7.7 million as of July 31, 2008, as compared to $7.6 million as of October 31, 2007. In June 2008, a number of the warrants issued as part of the $12.5 million private placement completed in January 2007 were exercised, generating proceeds of $7.8 million.
Net Loss
The consolidated net loss for the quarter was $2.0 million, or $0.01 per share, up from a consolidated net loss of $856,879, or $0.01 per share, for the same quarter last year.
About Haemacure
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 planned to enter pivotal Phase II/Phase III clinical trials during the first half of 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, skin graft fixation for burn injuries, combination with biomaterials, drug delivery, regenerative medicine, surgical hemostasis and wound healing. 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 is headquartered in Montreal, Quebec, and also operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under stock symbol HAE on the TSX.
Forward-looking Statements
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.
Financial Highlights
(unaudited)
Quarters ended
July 31, 2008 July 31, 2007
------------- -------------
Sales $25,593 $31,674
Gross profit $14,268 $12,943
Gross margin 56% 41%
General and administrative
expenses $879,413 $734,286
Research and development expenses $978,680 $158,534
Other expenses $99,029 -
Total expenses $2,037,154 $869,822
Net loss $(2,022,886) $856,879
Loss per share $(0.01) $(0.01)
Weighted average number of shares
outstanding 186,418,348 163,800,917
As at As at
July 31, 2008 October 31, 2007
------------- ----------------
Cash and cash equivalents $2,381,988 $3,591,883
Temporary investment $5,272,174 $4,011,200
Total assets $14,964,397 $10,939,289
Shareholders' equity $11,847,527 $9,226,329
SOURCE HAEMACURE CORPORATION
Tags: biotechnology business ceo clinical commercial dollar environment equity florida investment manufacturing market medicine montreal partnership pharmaceuticals Private Placement products quebec research and development salaries sales technology
Companies: Haemacure Corporation (HAE), Haemacure Corporation (HAEUF)
News from Zibb.com
- Presentation at BioContact Québec 2008 - Zibb.com
- Haemacure Appoints Thomas J. Lynch, J.D., Ph.D. to Board of Directors - Zibb.com
- Adhesion Prevention New Major Market Opportunity, Haemacure Confirms Effectiveness of its Fibrin
- Haemacure Provides Update on Fibrin Sealant Project and Reports Third Quarter Results - Zibb.com
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