Haemacure Confirms Effectiveness of its Fibrin Sealant in Second Preclinical Study

Haemacure Corporation (TSX : HAE), aMontreal-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, andto 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 severityof 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'sfibrin 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 toapply 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. Theprevious study, conducted in April 2008, also demonstrated that the use of Haemacure's fibrin sealant resulted in a statistically significant reductionin 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 studyused 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 timelymanner", 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 toUS$150-$200 million in fibrin sealant sales.

Cubist Pharmaceuticals Provides Update on Advancing Product Pipeline

Ecallantide for the prevention of bleeding in cardio-thoracic surgery:
Unmet Medical Need:
Cubist estimates that more than 650,000 patients annually undergo on-pump cardiothoracic surgery (CTS), which includes coronary artery bypass grafting (CABG) and heart valve replacement or repair procedures, in order to correct myocardial ischemia or diseased valves that cannot be treated with less invasive procedures. When a patient's blood comes into contact with the artificial surface of the cardiopulmonary bypass (CPB) machine and tubing, serious complications can result, including the systemic inflammatory response syndrome (SIRS), a whole body inflammatory state that compromises heart and lung function in already fragile patients. Blood loss also occurs as a result of this major surgery and can be exacerbated by SIRS. Aprotinin, an agent previously approved and marketed for the reduction of blood loss during on-pump surgery, was withdrawn from the market in 2008, creating a large unmet medical need.
Key Scientific/Clinical Data:
In a proof of concept study of ecallantide for the reduction of blood loss in CTS conducted by Dyax Corp, from whom Cubist obtained the rights to develop and commercialize ecallantide in North America and Europe for surgical indications in April, 2008, the magnitude of the treatment benefit, approximately a 50% reduction in transfusion volume compared with placebo, was consistent with the effects of aprotinin. In clinical trials to date, ecallantide has been well tolerated in healthy subjects and in patients undergoing CTS.
Status:
Cubist’s goal is to bring ecallantide rapidly to market as a therapy to reduce bleeding in CTS. To achieve this goal, Cubist plans to advance ecallantide as quickly as possible to a Phase 3 randomized controlled clinical trial. Cubist currently is developing the protocol for a definitive dose ranging study that the company expects will represent the completion of Phase 2 development.
Upcoming Milestones: Cubist plans to initiate a Phase 2 dose-ranging study year-end 2008.

Wyeth says New Recombinant XYNTHA Now Available

Wyeth Pharmaceuticals, a division of Wyeth, announced that product shipments have begun for XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, a new recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A, a rare, inherited blood-clotting disorder.Shipments of the Company's current recombinant factor VIII product, ReFacto Antihemophilic Factor (Recombinant) in the United States will be discontinued as of May 31, 2009.

Haemacure posts wider loss in Q3 - Update

Haemacure Corp. , a specialty bio-therapeutics company, reported Tuesday a wider net loss for the third quarter on lower revenue and higher operating expenses. The Montreal, Quebec-based company reported a net loss of C$2.0 million for the third quarter, wider than net loss of C$856 thousands in the same quarter last year. On a per share basis, the loss was flat year-over-year at C$0.01. Quarterly revenues declined to C$25 thousands from C$31 thousands in the previous year, reflecting the changes in the Canadian/US dollar exchange rate. The major source of revenues was from the sale of legacy fibrin sealant application devices. Operating expenses increased to C$2.0 million from C$869 thousands in the preceding year due to salaries and benefits for increase in personnel, purchase of supplies and raw material for the production of fibrin sealant, and clinical trials-related activities. As of July 31, the company had cash, cash equivalents and temporary investments of C$7.7 million. During the quarter, the company completed the construction phase of its manufacturing facility and started plasma processing in the unit. The company said that plasma processing is in line with expectations, and anticipates commercial launch of the product on the U.S. market at the beginning of 2011.In addition, Haemacure said it was carrying out development activities for expansion of its lead product candidate, human fibrin sealant, beyond its primary haemostatic and tissue sealant function.

CSMG Technologies Subsidiary Live Tissue Connect Awarded European Union CE Mark Certificate

CORPUS CHRISTI, Texas, Sep 02, 2008 (BUSINESS WIRE) -- CSMG Technologies, a technology management company, announced its subsidiary, Live Tissue Connect Technologies (LTC), has been awarded CE Mark (ConformitA(C) EuropeA(C)ne) certification for its Bipolar Forceps by BSI Product Services in its capacity as Notified Body for the Council Directive 93/42/EEC.
The CE Mark allows LTC to market its forceps with the previously CE Mark certified VAD.400 generator within the 30 countries of the European Economic Area (EEA) and Switzerland. This announcement follows LTC Technologies previously announced 510(k) clearance from the FDA to market both the aforementioned generator and forceps in the United States.
Obtaining CE Mark certification is an extensive process that requires evaluation of the device by the Notified Body to ensure compliance with EU directives and standards. To become certified, a company must have an established quality system and must submit a technical file providing evidence of compliance that the product meets applicable directives and standards.
The LTC Bipolar Forceps consist of two configurations of disposable instruments and are used exclusively with the LTC VAD.400 generator. Its intended use is for the application of electrosurgery in general surgery and gynecological procedures for the sealing of arteries, veins, and ducts. The Bipolar Forceps system is an alternative to mechanical clamping (clips or staples) and suturing, and can be used on veins and arteries up to 7mm diameter, on ducts up to 2mm diameter and on tissue bundles as large as will fit between the jaws of the instrument.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased to announce LTC has received this CE Mark certificate. Combined with their FDA 510(k) clearance, LTC may now begin the process of marketing their sealing system in both Europe and the United States. I want to congratulate the LTC Technologies division, headquartered in Santa Barbara, whose efforts succeeded in securing this very important certification."
Frank D. D'Amelio, President of LTC Technologies added, "We have set forth an aggressive schedule for commercialization of LTC's technology and we continue to execute against that plan as evidenced by the receipt of this CE Mark certificate and our recent FDA 510(k) clearance. In addition, achieving this CE certification demonstrates our commitment to be a global organization with world-wide distribution. Our sales recruitment efforts are proceeding according to plan and potential dealers have expressed much enthusiasm for our technology and the opportunity to join the LTC sales team."

Bayer Submits Recombinant Human Thrombin for European Approval

2 Sep 2008 , Berlin : Bayer Schering Pharma has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for recombinant human thrombin (INN: thrombin alfa) as a topical aid to control surgical bleeding.Thrombin alfa is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the global rights to thrombin alfa for all markets outside the US. ZymoGenetics retains US market rights and Bayer provides its sales force to support the first three years of the US market launch. Thrombin alfa received United States Food and Drug Administration (FDA) approval in January 2008 and is marketed as Recothrom® Thrombin, topical (Recombinant). Bayer plans using the product name Recothrom® globally, pending regulatory approval.Thrombin alfa is a recombinant form of human thrombin that is structurally and functionally similar to the natural enzyme which is an important factor in the blood clotting cascade. Used in surgery, the product is applied topically to the operation wound and may be administered as a spray or with a surgical sponge. Upon application, thrombin alfa activates the final steps of the coagulation cascade to stop the bleeding. The biotechnologically produced recombinant thrombin alfa provides surgeons with a plasma-free thrombin alternative for surgical hemostasis. As it is not derived from animal or human blood, it does not imply the risk of infections which is generally associated with plasma products.In Europe, there are in excess of 4 million surgical procedures performed annually where a hemostatic product may be used and surgeons currently have to rely on either sponges or tissue sealants. Thrombin alfa would be the first stand-alone thrombin product to control bleeding during surgery and may improve the therapeutic options in Europe.

HemCon Medical Technologies, Inc. and IT/Sligo Join Forces

PORTLAND, Ore. & SLIGO, Ireland--(BUSINESS WIRE)--HemCon Medical Technologies today announced an agreement with IT/Sligo (Institute of Technology Sligo, Ireland) to license the exclusive global rights to research, develop, manufacture and market a controlled release hydrogen peroxide technology that provides broad spectrum antibacterial and antiseptic properties.
This proprietary platform technology provides a full range of product solutions for the wound care, oral care and personal care markets ranging from antimicrobial professional products to personal hygiene solutions for consumers. The technology allows entry into major new market opportunities for HemCon Medical Technologies. Of particular significance the technology has shown good potential in early studies for the treatment of fungal nail infection. Fungal nail infection affects tens of millions of people in the U.S. and the global market size for its treatment products is approximately US$4 billion.
The platform technology releases hydrogen peroxide through a carefully controlled proprietary process allowing control of the dose and of the period of delivery of the produced hydrogen peroxide. The hydrogen peroxide at the required level is slowly released over a controlled time, providing a steady dose while ensuring that the levels produced are below those that could be harmful.
“The new licensing agreement with IT/Sligo is an exciting partnership for HemCon as we continue to grow and pioneer new products in wound care and healing,” said John W. Morgan, CEO of HemCon. “This particular technology will also expand our presence in key markets like fungal care. With more than 40 million Americans fighting fungal infections, it will be a valuable new tool for effective treatment.”
The agreement will allow HemCon the ability to directly commercialize or sub-license these technologies to key medical device and pharmaceutical partners globally.

WoundStat Inventors Recognized for Their Outstanding Medical Research Contributions to Combat Casualty Care

BETHESDA, Md., Aug 13, 2008 (BUSINESS WIRE) -- Virginia Commonwealth University (VCU) researchers Kevin Ward, MD, Robert Diegelmann, PhD, and Gary Bowlin, PhD, this week received the Award for Excellence in recognition of their outstanding contributions to combat casualty care from the US Army Medical Research and Materiel Command, Combat Casualty Care Research Program. The three invented WoundStat(TM), a ground-breaking hemostatic agent for control of bleeding in high-pressure arterial wounds, which are a common combat injury. The award was given to the group "in recognition of their hemorrhage control research, and the resultant development of WoundStat, a product that will significantly increase survival of the combat wounded."
The award was given at the Advanced Technology Applications for Combat Casualty Care (ATACCC) 2008 Conference, and this is one of the few times the award has been given to someone who was not a member of the military.
"I'm gratified, and I'm proud of the award," said Dr. Ward. "Our team did great work in inventing WoundStat. It is rewarding knowing that your work can help save lives of warfighters and other trauma victims, and it is great to be recognized as well."

Omrix Biopharmaceuticals mulls hedge fund buyout offer

Sources inform that Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) has received a buyout offer from a US hedge fund for $25 per share, amounting to $430 million, in a deal that would take Omrix private. Omrix closed at $22.13 on Friday, giving a market cap of $378.8 million. The offer represents a 14% premium on the company's market cap.
The company had no comment on the report.
Omrix's share has risen 57% in recent months on reports that something interesting was going on there, as well as the company's quite strong financial report for the second quarter, published last week.
The sources added that, a few months ago, Omrix received an acquisition offer from Johnson & Johnson (NYSE: JNJ) unit Ethicon Inc., with which Omrix has a distribution agreement. Omrix turned the offer down because it felt that the offer was too low. Omrix president and CEO Robert Taub is now examining the offer from the US hedge fund, and he will reportedly send it to Ethicon to give it an opportunity to make a better offer of its own.
Omrix had claimed in the past that Ethicon was not making a strong enough effort in marketing the company's biosurgical sealants and other products. However, the company's appear to have settled their differences and their relationship is as good as ever.
Omrix will have to make a share buyback offer in order to sell the company to a private company and delist from Nasdaq. Omrix's holdings are quite dispersed. Taub owns 9.4% of the company and, together with four other private parties, owns 17%. The public and institutional investors own the rest, including 7% by Adage Capital Partners GP LLC, 5.6% by Oberweis Asset Management Inc., and 4.4% by Orbimed Advisors LLC.

Factor VII Curbs Bleeding in Non-Hemophiliac Trauma, Surgical Patients

Use of recombinant activated factor VII (rFVIIa) reduces the need for blood transfusion in patients without hemophilia and may also reduce mortality, according to pooled data from randomized placebo-controlled trials involving more than 3000 participants, Canadian researchers report.
"I had found it to be effective in some combat situations in Afghanistan," senior investigator Dr. Vivian C. McAlister told Reuters Health. "I was therefore dismayed when I noticed that rFVIIa was being dismissed by some influential physicians as being expensive, dangerous and ineffective."That report, by US Federal Drug Administration (FDA) physicians, he added, "was flawed because it only looked at adverse events that had been reported."To gain a more balanced picture, Dr. McAlister and colleagues at the University of Western Ontario, London conducted a meta-analysis of 22 trials involving 3184 patients without hemophilia. Trial settings included trauma, variceal bleeding, cardiac surgery, liver transplantation and other surgeries. The team's findings appear in the July issue of the Annals of Surgery."When we combined results," continued Dr. McAlister, "we found rFVIIa to be effective in controlling hemorrhage and to save lives without increasing the risk of venous thrombosis."Specifically, compared to placebo, patients receiving rFVIIa were less likely to require additional blood transfusions (odds ratio, 0.54). Mortality was not increased and may have been reduced in patients receiving rFVIIa (OR, 0.88). The mortality reduction seemed more likely when the agent was given therapeutically, rather than prophylactically.There may have been a higher incidence of arterial thromboembolic events (OR, 1.50) but not venous thromboembolic events (OR, 0.76) in patient given rFVIIa, although the differences did not reach statistical significance."There was an increased rate of heart attack in patients who received rFVIIa," Dr. McAlister pointed out, "but it is not known if this was due to the stress which they had survived or related to rFVIIa itself.""Subgroup analysis," he concluded, "suggested the most effective way to give rFVIIa is in lower doses to stop, rather than to prevent, bleeding."