ZymoGenetics Secures $100 Million Funding Commitment

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced that it has received a $100 million funding commitment from Deerfield Management, a leading healthcare investment organization and a significant ZymoGenetics' shareholder. The funds can be drawn at any time over the next 18 months at ZymoGenetics’ discretion. Funds drawn, together with accrued interest, will be repayable five years from entering into the funding arrangement and can be repaid without penalty at any time at the company’s sole discretion.

“This transaction significantly increases our financial strength and provides capital that we’ll use to build our RECOTHROM® business, including the potential development of RECOTHROM line extension products,” said Bruce L.A. Carter, Ph.D., chief executive officer of ZymoGenetics. “We’re pleased with this vote of confidence from Deerfield, a highly knowledgeable and successful healthcare investment firm.”

Under the terms of the arrangement, Deerfield has committed $100 million that can be drawn by ZymoGenetics in $25.0 million tranches. Each tranche will entitle Deerfield to a royalty equal to 2% of RECOTHROM net sales. In addition, ZymoGenetics will issue Deerfield 1.5 million warrants exercisable at $10.34 at the time of the first draw and 1.0 million warrants upon each subsequent draw exercisable at a 25% premium to the average sale price for a previous 15-day period. All warrants will have a 6 year term and the company has agreed to register with the Securities and Exchange Commission the common stock issuable under the warrants. Interest will accrue on drawn capital at a compounded rate of 4.9% and be due along with outstanding principal in June 2013, subject to acceleration in specified circumstances. ZymoGenetics can repay borrowed amounts in whole or in part at any time, without penalty, and all associated interest and royalty obligations will cease upon repayment. Deerfield received a $1 million transaction fee upon entering into the arrangement.

“We believe that this transaction with Deerfield is structured to benefit our shareholders in several ways,” said James Johnson, chief financial officer of ZymoGenetics. “ZymoGenetics gains access to a significant amount of capital at a competitive cost; there is flexibility in amount, timing and duration of borrowings; and shareholder dilution is minimized. Assuming success in building the market for RECOTHROM and in carrying out our business development objectives, this added capital should fund our company well into the future.”
A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.

Nanotech in the O.R.

Arch Therapeutics CEO Terry Norchi talks about the company's technology and the challenges of bringing a new product for surgeons to the market.

Angioplasty.Org discusses the transradial approach to catheterization and intervention with Dr. Mauricio G. Cohen

A landmark situation was a patient where we had to use a vascular closure device. The ones that I was most familiar with were the Angio-Seal and the Perclose device. We had had a complication at UNC with a Duett device, which consists of a balloon occluding the femoral artery, and then a small injection of thrombin to seal the vessel. But there was a spill of thrombin into the femoral artery, and the patient had to undergo peripheral thrombolysis to reperfuse the lower extremity that was affected. So that was one complication that had not occurred to me.
But then I had another complication that really upset me: an infection of a Perclose suture. The patient had to go through significant pain and suffering, had to go for surgery, remained with chronic pain and had to receive long-term intravenous antibiotic therapy to treat an infected pseudoaneurysm.
It was then that I decided enough was enough!! I had to find a safer way to deal with these patients......................................Read the full Interview HERE

Pharming Acquires Licences To Key Fibrinogen Patents

Leiden, The Netherlands, June 25, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has acquired an exclusive sub-license to key patents and technology on recombinant fibrinogen from GTC Biotherapeutics Inc ("GTC"). These rights enable Pharming to accelerate pharmaceutical development of recombinant human fibrinogen (rhFIB) and stimulate medical device development through its biomaterials program.Pharming has obtained exclusive licenses on recombinant fibrinogen for all indications in various territories, including North America, Europe and Japan. The licenses are to recently issued patents owned by the American Red Cross, Virginia Tech Intellectual Properties Inc and the University of North Carolina on the production of recombinant fibrinogen in milk of transgenic animals which are licensed to GTC from ProGenetics, LLC. The license agreement includes an upfront payment to GTC of approximately € 350,000 (US$ 550,000) and a royalty on commercial sales of rhFIB. Pharming already owns several additional patents and licenses for recombinant fibrinogen and recombinant tissue sealant compositions. The acquisition of the license from GTC further broadens and strengthens Pharming's position in this field.Pharming has a development program for recombinant human fibrinogen as a replacement therapy for genetic and acquired deficiencies of fibrinogen. The existing market size for fibrinogen deficiencies is estimated to be over USD 500 million in the developed world. In addition to the deficiency market, rhFIB has the potential as a pharmaceutical product to address the significantly larger market of traumatic and surgical bleeding in excess of USD 1 billion. Current standard of care in the US for patients deficient in fibrinogen is the use of cryoprecipitate, which is composed mainly of plasma derived fibrinogen. In certain European countries, a partially purified plasma fibrinogen product is marketed.Pharming has successfully produced high levels of rhFIB using its production technology. This was a technical breakthrough given the biochemical complexity of the fibrinogen molecule consisting of several subunits folded together in fixed ratios. In laboratory tests and initial animal studies, rhFIB has been demonstrated to be virtually identical in structure and function to plasma fibrinogen.Bruno Giannetti, Chief Operations Officer, commented: "Securing the patent rights is important for the development of recombinant human fibrinogen, a key part of our product portfolio. We can now accelerate development of our fibrinogen product for pharmaceutical use and establish partnerships for medical device development. Pharming has already provided rhFIB for evaluation to several device manufacturers and research institutions to facilitate novel product development for various applications. Over the last few years, the Company has been building a program on biomaterials through collaborations with the BioMedical Materials consortium (BMM) in The Netherlands, NovaThera Ltd, the US Army and other institutions."About recombinant human fibrinogen (rhFIB) Human fibrinogen is a natural human plasma protein involved in blot clotting. Deficiency or low levels of fibrinogen can result in uncontrolled bleeding, as can occur in case of trauma, surgery, liver disease, sepsis and cancer. Pharming is developing recombinant human fibrinogen (rhFIB) as a replacement therapy for patients with genetic and acquired deficiencies of fibrinogen. The existing market size for fibrinogen deficiencies is estimated to be over USD 500 million in the developed world. In addition to the deficiency market, rhFIB has the potential as a pharmaceutical product to address the significantly larger market of traumatic and surgical bleeding in excess of USD 1 billion. In addition to pharmaceutical development of rhFib, Pharming will pursue partnerships with medical device manufacturers on rhFIB to build further value for its biomaterial portfolio.

TraumaCure Receives Prestigious ISO 13485 Certification

BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company received FDA clearance to sell WoundStat in August 2007
With ISO 13485 certification, TraumaCure meets global quality design and manufacturing requirements. ISO certification is a base-line requirement in many key markets for approval to sell a medical device and therefore supports TraumaCure’s plans to market WoundStat to nations around the world.
“As the only hemostatic agent proven to be 100% effective in four different studies, we are seeing worldwide demand for WoundStat,” said Devinder Bawa, CEO of TraumaCure. “TraumaCure has put the processes and procedures in place to ensure the global availability of a consistent, safe, and effective product that is ready to save lives, anytime and anywhere it is needed.”
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO has more than 16,500 International Standards in its current portfolio, ranging from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, the environment, safety, information and communication technologies, and to standards for good practice and for services.
ISO 13485 is an internationally recognized quality standard for the design, development, production, and sales of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
TraumaCure was certified after rigorous audits and extensive document reviews to ensure that TraumaCure’s quality management system (QMS) is run in accordance with the globally recognized standard.

CSMG Technologies Subsidiary Live Tissue Connect Presents Its Bipolar Continuous Welding of Tissue at the 2008 Future Medical Forum

CORPUS CHRISTI, Texas--(BUSINESS WIRE)--CSMG Technologies, Inc. (OTCBB: CTGI) a technology management company, announced Mr. Frank D’Amelio, President of Live Tissue Connect (LTC), a subsidiary of CSMG Technologies, presented at the 2008 Virtus International Future Medical Forum in Tampa, Florida. This medical forum focuses on the impact new technologies and materials have on the discovery, development, and design of medical devices. The Future Medical Forum is a significant medical device event, as it brings together some of the leading minds and decision makers in the medical device industry for a two day conference.
Mr. Donald S. Robbins, President and CEO of CSMG Technologies, said, “We are pleased that LTC’s President, Frank D’Amelio, has been invited back to the Future Medical Forum for a second consecutive year. Since last year, Live Tissue Connect has made significant technological advancements and is excited to introduce them to the world’s leading medical organizations and ancillary support companies.”

GlaxoSmithKline: FDA extends priority review period for Promacta

SAN FRANCISCO, Jun 21, 2008 (Thomson Financial via COMTEX) - GlaxoSmithKline late Friday said the Food and Drug Administration has extended to Sept. 19 the priority review period for Promacta, a short-term treatment for idiopathic thrombocytopenic purpura.
ITP is a condition in which the blood doesn't clot properly because patients don't have sufficient platelets.
The FDA's oncology drugs advisory committee May 30 unanimously voted that Promacta demonstrated a favorable risk-benefit profile for the short-term treatment of patients with chronic ITP, GlaxoSmithKline said.
U.S.-listed shares of the UK-based pharmaceutical company down 27 cents at $43.37. Brigid Gaffikin bg/gm

Neomend Inc.

IRVINE, Calif., June 17 /PRNewswire/ -- NeoMend, Inc. today announced that its ProGEL(TM) Surgical Sealant has received a recommendation for approval from the U.S. Food and Drug Administration's (FDA) Anesthesiology andRespiratory Therapy Devices Advisory Panel.The panel's recommendation will be considered by the FDA during completion of its review of the Premarket Approval (PMA) for ProGEL. The panel's recommendation for FDA approval was conditioned principally on NeoMend conducting a post approval study to gather more safety data.

While Neomend products are for sealing, and anti-adhesion they also are conducting trials of a vascular closure product ProGEL-VS

Haemacure Raises $7.8 Million and is Fully Funded Beyond First-Patient-In-Clinic

MONTREAL, June 16 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, announces that it has raised $7.8 million through the exercise of amended Series B warrants and broker warrants issued as part of the private placement concluded in January 2007.

"I sincerely thank our shareholders who demonstrated their strong supportby exercising their warrants. We now have the financial resources to execute on all of the necessary milestones to get our fibrin sealant into the clinicin Q1-09. This financing significantly reduces the financial risk. All of ourtime and attention will be focused on execution and getting a green light from the FDA to enter clinical trials." said Joseph Galli, Chairman and CEO ofHaemacure.

Recombinant collagens and synthetic gelatins

FibroGen is the only producer of highly purified, fully characterized recombinant collagens and synthetic gelatins intended to replace similar animal- or plasma-derived materials currently used in a variety of medical, pharmaceutical, and consumer applications. The company's fermentation system enables the large-scale production of medical-grade materials. FibroGen's collagens and gelatins are fully synthetic materials that eliminate the risk of contamination with disease-causing pathogens such as viruses and prions. Currently FibroGen's products are intended for laboratory research purposes only and are not to be used in humans or for any other purposes, including but not limited to, in vitro diagnostic purposes, foods, drugs, medical devices or cosmetics or animals or for commercial purposes.

Autologous Products

Scandanavian company Vivolution sells their product range the Vivostat® System in Europe comprising two groups of products that utilize the same patented technology. The Vivostat®System is an automated system for the on-site preparation and application of patient-derived fibrin sealant or platelet rich fibrin (PRF®). It incorporates a unique and patented biochemical process that produces an autologous sealant from 120 ml of the patient’s own blood in only 23 minutes.
Vivostat® autologous fibrin sealant is used during surgery to prevent and stop bleedings and oozing of body fluids.
Vivostat® PRF® autologous platelet rich fibrin is used to promote cell growth for a range of procedures e.g. orthopaedic surgery and wound healing.

PlasmaSeal has designed three devices (called Cebus, Ateles, and Proteus) that produce Platelet Plasma Concentrate from the patient's own blood. From a regulatory perspective PPC is an autologous blood product. PlasmaSeal PPC technology is remarkably simple to use. Depending on the extent of wounded area 10 to 100 cc of blood is withdrawn from the patient and immediately mixed with standard citrate anticoagulant. The platelet plasma is separated from whole blood by centrifugation, then it is concentrated by removing some of the salt water. This second step can be accomplished in many ways. A simple method, called hollow fiber concentration uses small tubes with special walls, which are porous to salt water but not to the larger proteins and platelets in blood. It is this basic procedure and two step method that is used in all the devices.

Thermogenesis offer the advanced CryoSeal® FS System a new generation of performance for the production of fibrin sealant. The system safely and conveniently extracts high-quality fibrinogen-rich cryoprecipitate and thrombin from a single unit of autologous or allogenic plasma in approximately 60 minutes. Also the advanced Thrombin Processing Device (TPD™) provides busy operating rooms and other fast-paced environments with a rapid, safe, easy-to-use method for producing active human thrombin from either plasma or whole blood.

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Inoteb has developed what it believes to be the world's first fully autologous biological glue. This Autologous Biological Glue is prepared using the patient's own blood, in a closed system, eliminating immunologic problems and the risk of blood-borne disease transmission such as, for example, HIV and hepatitis. In contrast, all surgical glues currently on the market (whether autologous or homologous) require foreign proteins such as thrombin or antifibrinolitic agents. Clinical trials have been done especially for skin replacement and skin grafts eliminating the need for protein based skin grafts.In its use to date in European trials, the Autologous Biological Glue has been shown to be clinically safe and effective. Biocoral, Inc. will continue to push through the clinical trials examining the use of the Autologous Biological Glue for cosmetic applications, utilizing well-known plastic surgeons in Europe and the United States.

Novo stops NovoSeven trauma Phase III trial

COPENHAGEN, June 11 (Reuters) - Denmark's Novo Nordisk (NOVOb.CO: Quote, Profile, Research) said on Wednesday it stopped a Phase III trial with its NovoSeven drug for treatment of bleeding in severe trauma, but added the decision was not due to safety concerns.
It said the study population had a mortality rate of 10 percent compared to more than 25 percent in the preceding Phase II trial. The study, it said, was unlikely to determine whether NovoSeven would be successful in this treatment area.
"Of course it's not positive but I had not factored in an additional (indication) for NovoSeven," said Sydbank analyst Rune Dahl. "The way to view NovoSeven currently is as (a drug with) stable sales in its existing area, and nothing more." NovoSeven is a haemophilia drug with total sales of 5.9 billion Danish crowns ($1.23 billion) last year.
By 1302 GMT, Novo shares were down 1 percent at 310 crowns on the Copenhagen exchange after briefly falling as much as 4 percent.
A Novo Nordisk spokesman said that the company had not yet decided whether to design a new Phase III study with NovoSeven for bleeding in severe trauma.
In February 2007, Novo Nordisk halted regulatory filing for the drug for bleeding in the brain after initial results from a Phase III clinical trial showed NovoSeven reduces bleeding in the brain but does not improve long-term clinical outcomes.

Vascular Closure an interesting comparison

All VCDs have demonstrated rapid hemostasis and a decreased time to ambulation when compared to manual compression(1-4). Vasoseal™ has been associated with the highest risk of infection, while Angiolink™ and Starclose™ are felt to have the lowest risk (1-4). Angioseal™ theoretically has a higher risk of thromboembolic events due to the intravascular collagen anchor. The suture-mediated devices utilize primary healing (end to end anastomosis at the arteriotomy site), but are the most complex technically and have the highest rate of device and operator failure. Collagen and ProcoagulantsThe Vasoseal™ closure device (Datascope Corp., Montvale, NJ) was introduced in 1995 (revised in 1999and 2002) and utilizes an extravascular Type-1 collagen produced from bovine tendons. When deployed at the arteriotomy site the collagen initiates coagulation by activating platelets (secondary healing). Vasoseal™ isFDA approved for both diagnostic and interventional procedures, with a single device used for 5-8 French sheath sizes. The Angio-Seal™ device (St. Jude Medical, St. Paul, MN) achieves hemostasis by sandwiching the puncture site between an intravascular bio-absorbable (over 8-12 weeks) anchor and an extravascular bovine.......................Read more HERE (its a verified safe download from Adrive)

For Current US Vascular Closure Trials go HERE

Vascular Closure - Hemostasis of the femoral artery

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products

Morris Innovative - FISH

St.Jude - Angioseal

Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD

Covidien - VascuSeal

Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal

AccessClosure - Mynx

Cardiva - Boomerang

Medafor - MPatch

Sutura - SuperStitch

Vascular Solutions - Duett, Duett Pro, D-Stat

Radi Medical - FemoStop, RadiStop

Vascular Closure

Lets take a look at the vascular closure hemostat range starting with a look at the market with Kensey Nash. There is a full presentation available HERE but key slides featured below.

Cerus Announces INTERCEPT Blood System Data

Results from 32 Studies Highlight the INTERCEPT Blood System's Ability to Improve the Safety of Donated Blood by Inactivating Viruses, Bacteria, Protozoa and Leukocytes
CONCORD, Calif., Jun 09, 2008 (BUSINESS WIRE) -- Cerus Corporation (NASDAQ:CERS) announced today results from 32 studies on the INTERCEPT Blood System presented at the International Congress of the International Society of Blood Transfusion in Macao SAR, China. Study outcomes highlight clinical experience implementing the INTERCEPT Blood System for platelets and plasma into routine practice. Others demonstrate INTERCEPT's utility in the inactivation of current and emerging pathogens, such as malaria and avian influenza, in donated blood. The safety and efficacy of the INTERCEPT Blood System are also highlighted in results from a multi-year hemovigilence surveillance program and in a study of patients with a severe congenital bleeding disorder undergoing major surgery.
"The clinical outcomes from these studies further support the broad application of the INTERCEPT Blood System to increase blood safety and improve results for patients who require blood transfusions," said Laurence Corash, M.D., senior vice president and chief medical officer at Cerus Corporation. "More than 150,000 INTERCEPT Blood System disposable kits have been shipped to date to more than 60 sites in 20 countries, with mounting evidence for continued broader adoption of our pathogen inactivation technology."

Comparison of Celox, Hemcon and Quikclot

Celox sent me this report comparing Hemcon and Z-medica with Celox HERE (its a verified safe Pdf download from adrive).
Given the positive results I was left wondering why this product was not the sole choice of the Military, in particular the US forces?
So I emailed Craig Hardy, CEO, MedTrade Products Ltd and asked him........

Me: According to the Jan. ’08 Portsmouth pdf study (comparing Celox with Hemcon and Z-medica’s, Quikclot) the results indicate Celox shows a 100% survival rate. Is this product currently undergoing any evaluation by the military?

Craig: Yes. Celox is used in some performance critical areas of the military and being evaluated in many others. Its an ongoing process.

Me: Given that Medtrade is a U.K. based company what (if any) impact has this had for the uptake of Celox by the U.S. military?

Craig: In the US, Celox is distributed to the Military through Sam Medical in Portland Oregon. The UK is a very close ally of the US. We have heard of no decisions made on the basis of location. However our head office location means we are not as politically connected as some competitors and I believe this may have a significant effect.

ZymoGenetics to Webcast Presentation at Needham Conference

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that James A. Johnson, Executive Vice President and Chief Financial Officer, will provide an update on company activities at the Needham Biotechnology and Medical Technology Conference in New York on Wednesday, June 11, 2008 at 11:30 a.m. Eastern Time.

A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.
Here are some slides from a previous presentation

Orthovita to Present at the Seventh Annual Biotechnology and Medical Technology Conference

MALVERN, Pa.--(BUSINESS WIRE)--Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it will present at the Needham & Company, LLC Seventh Annual Biotechnology and Medical Technology Conference in New York. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Thursday, June 12th, at 2:30 p.m. Eastern Time, at The New York Palace Hotel, 455 Madison Avenue, New York, NY. A live audio webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting HERE.

Entegrion

Just received this video to share with you of Entegrion created Stasilon and its mode of action.

Haemacure Achieves Major Milestone - Starts Processing Plasma in Its New Fractionation Facility

MONTREAL, June 4 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), aMontreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, announces that it has started processing plasma in its new fractionation facility for the production of its proprietary all-human fibrin sealant for pivotal Phase II/Phase IIIclinical trials, leading to commercial launch. Haemacure has reached an important milestone this week with the commencement of plasma fractionation in its new manufacturing facility.Haemacure also confirms that it is on schedule and on budget to produce clinical material during the third quarter of 2008 and file an amendment to its existing IND with the U.S. Food and Drug Administration during the fourth quarter of 2008, in order to begin clinical trials in the first quarter of2009. The new fractionation facility incorporates the Hynetics(R) single-use bio-processing plastic containers technology, which has resulted in significant savings in capital expenditures and will also result in significant savings in operating costs, as compared to a stainless steel facility. The use of this technology also minimizes the risks of cross-contamination between production batches. "Now that our fractionation facility is operational and that we have started processing plasma, Haemacure is truly engaged in its transformation from a development to a manufacturing company." said Joseph Galli, Chairmanand CEO of Haemacure. "The upcoming availability of clinical material willenable Haemacure to pursue its clinical plans in hemostasis and to expand into additional indications, such as adhesion prevention." concluded Mr. Galli.

Plasma Derived Products:Pathogen Safety of EVITHROM™

Here is a link through to a presentation by Bernard Horowitz, Ph.D. discussing the safety of (Omrix manufactured) J&J's Evithrom, you have to register first.

Omrix do concede that "Our products are derived from human plasma, and are therefore subject to the risk of biological contamination inherent in plasma-derived products. This risk could adversely affect our ability to obtain raw materials and market our products. " In THIS document

Info from Omrix Biopharmaceuticals tells us Bernard Horowitz, Ph.D. has served as a member of our Board since February 2006. Since January 2000, he has been a principal of Horowitz Consultants, LLC, a company providing assistance in strategic planning, process development, viral safety, clinical trial design and new product regulatory compliance. From 1995 to 1999, Dr. Horowitz served as chief scientific officer, executive vice president and director of V.I. Technologies, Inc., now Panacos Pharmaceuticals, Inc., a now publicly held company he helped found as a spin-out from the New York Blood Center. Dr. Horowitz has served as a scientific consultant to the National Institutes of Health, the Food and Drug Administration, the National Hemophilia Foundation, the International Association of Biological Standardization, and the World Health Organization. Dr. Horowitz is a co-inventor of over 25 issued U.S. patents. Dr. Horowitz received his B.S. in biology from the University of Chicago and his Ph.D. in biochemistry from Cornell University Medical College. He is a director of Protein Therapeutics, Inc.

US Department of Defense Recommends Soldiers Carry WoundStat™

BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. announced today that the DOD Joint Committee on Tactical Combat Casualty Care (CoTCCC) has recommended that U.S. soldiers from all services carry the company’s hemostatic agent, WoundStat™. The CoTCCC based its recommendations upon the results of extensive studies conducted by both the Army’s Institute for Surgical Research (ISR) and the Naval Medical Research Center (NMRC). In those studies, no other product was as effective across the board in terms of survival, post treatment blood loss, and duration of hemostasis.
This is the first time ever that all branches of the military have come together and jointly recommended the same product for the most severe injuries involving high-pressure bleeding.
“Severe bleeding is the number one cause of death for soldiers injured in battle. The ISR study clearly shows WoundStat works consistently to stop serious bleeding quickly. In light of these study results, WoundStat will be a critical product in the field available to all soldiers in harm’s way, where and when it is needed most,” said Ron Blanck, retired US Army Surgeon General. “Approximately 80% of injuries in the current conflict are from improvised explosive devices (IEDs), which result in the severe and irregular wounds that WoundStat is specifically designed to treat. In those situations, WoundStat works in seconds, not minutes.”
Four different studies—including the one conducted by the Army’s ISR, along with others conducted at Virginia Commonwealth University, the Air Force, and NAMSA—have now proven that WoundStat is the most effective hemostat available for high pressure arterial wounds. In each of these studies, WoundStat was the only product that resulted in 100% survival. The novel wound treatment works through standing blood and has the added advantage that, should re-bleeding occur, a wound can be re-packed with the WoundStat already present—a real advantage in combat conditions.
“The Joint Committee on TCCC recognized WoundStat’s overall advantage in both effectiveness and safety. It is now clearly proven that, with its consistent reliability and efficacy, combined with its speed of use, WoundStat offers the highest level of operational field capability for our warfighters,” noted Devinder S. Bawa, CEO of TraumaCure.
TraumaCure has enough WoundStat in stock to equip every soldier currently deployed in the Middle East theater. The cost of WoundStat is about one-third that of the product the Army has been using for the past several years. WoundStat is also available for domestic use by emergency responders and others who need to be prepared for treating traumatic injuries.

Recothrom, Evithrom, Thrombin JMI

Anyone interested in Thrombin, Zymogenetics, King and J&J should follow this blog by Joe Tartakoff.
During last week's ZymoGenetics conference call, Ed Tenthoff of Piper Jaffray asked ZymoGenetics CEO Bruce Carter if he was noticing any moves by Johnson & Johnson.
Here's the exchange:
Tenthoff: Can you just update us on where pricing is for RECOTHROM and how some of the competitors have responded, and there's, you know, we've noticed very little in terms of noise from Evithrom ...
Carter: With the bovine thrombin, we are seeing a limited discounting... And like your search for J & J (Johnson & Johnson), I guess it's fair to say they are out there, but perhaps not as much as one might have expected from the name Johnson & Johnson. In fact, I could go stronger, surprisingly little considering it's Johnson & Johnson.
Omrix Biopharmaceuticals, which sells Evithrom along with Johnson & Johnson, begs to disagree.
During Omrix's conference call to report its results, CEO Robert Taub was asked how he would characterize "your market share for thrombin versus competitors, including both King and ZymoGenetics."
His response:
"I think we -- well we'll put it this way. Obviously our market share of thrombin is lower than King and it is higher than ZymoGenetics."
Then, another analyst pressed him on why that was the case, considering that the conceptual risks associated with cow-derived thrombin (that patients would develop antibodies against the product) would probably be the same with a human-derived one.
Taub's response:
Bovine thrombin has been around for so many years, and the arguments about antibody formation, it's not very convincing and you have to be very careful. I heard that the FDA gave a warning just two or three days ago to some very aggressive promotional literature by ZymoGenetics on that. So the need, if you want, to change is not very high. So I think what's really driving it is contracts, introduction in the hospitals, bundling, and sales mention and service at this stage.
Still, Taub conceded that the thrombin market was a difficult one to break.
In a release last week announcing its first-quarter results, the company said Evithrom sales "continue moderate growth." Read the release here.
And during the call, Taub used the word "slow" twice to refer to the market for thrombin:
... As we have expected the stand-alone thrombin market is and will change slowly. It's a slow process. While stand-alone thrombin will continue to to be an important product, we also continue to believe that long-term thrombin growth will ultimately be driven by thrombin-based enhanced hemostats, where thrombin is combined with other agents such as various forms of gelatin and which will be easier to use.
Overall, it seems that Evithrom is running into many of the same hurdles as ZymoGenetics, which is having to wait for hospitals that have used the King product for years to vote to allow the use of Recothrom.
Taub:
... There seem to be very low awareness of any risks related to bovine thrombin. And the manufacture of bovine thrombin has been sitting on their market position for a long time and the ramp up is slow, because of the P&T (hospital) committees, and these contracts that have to be done... There is also less way to innovate unless you develop, which we are planning and doing with J & J.
Source: SeattlePI

Haemacure Reports on Financing Progress

MONTREAL, June 2 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, provides financing update and reports on second quarter results. Financing As a result of the commitments Haemacure has received to-date from key shareholders to exercise their Series B warrants, the Corporation is wellpositioned to meet its objective of commencing the fibrin sealant pivotalPhase II/Phase III clinical trials. The Corporation remains on schedule and onbudget with the construction of its manufacturing facility. "We are very appreciative and encouraged by the strong support we have received from our major shareholders, Firebird Management and PinetreeCapital, as demonstrated through the exercise of their Series B warrants."said Joseph Galli, Chairman and CEO of Haemacure. "This support, coupled with the recent addition of Reinaldo Diaz to our Board of Directors and the hiring of senior managers at our facility, are elements of our value creation strategy that will make Haemacure a significant player on the global scale."concluded Mr. Galli.

Reinaldo M. Diaz
Reinaldo Diaz has over 25 years of experience in the biopharmaceutical industry. Prior to joining Celtic Pharma, he was Managing Member and Co-Founder of D&A Capital Management, LLC (“D&A Capital”), a firm focused on asset management and providing advisory services to companies in the Healthcare sector, particularly biopharmaceutical companies. D&A Capital, through affiliated entities, managed the Delta Opportunity Funds (“Delta”), a group of hedge funds with over $100 million in assets under management.

Novo Nordisk and Neose Announce Completion of Initial Phase 1 Clinical Trial

COPENHAGEN, Denmark & HORSHAM, Pa.--(BUSINESS WIRE)--Novo Nordisk A/S (NYSE:NVO) and Neose Technologies, Inc. (Nasdaq GM:NTEC) today announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated Factor VIIa), a long-acting version of NovoSeven® Coagulation Factor FVIIa (Recombinant) administered intravenously. The trial assessed the safety and pharmacokinetics of NN7128 in 30 healthy subjects.
In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Søren Bjørn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”
“We are encouraged by the safety and pharmacokinetic profile that NN7128 has demonstrated in this Phase 1 study,” said George J. Vergis, Ph.D., Neose President and Chief Executive Officer. “We look forward to continued progress in the clinical development of this compound.”