Free Hemostasis Ebook Resource

This 2004 handbook is designed to be a resource for both the common and uncommon hemostatic problems that health care providers often face in clinical practice. Currently there is no practical up-to-date book to help the clinician with these patients. The handbook was written to offer a practical guide to recognizing, diagnosing, and managing theses patients. One of the most remarkable areas of medicine in the last ten to fifteen years is the revolution in thrombotic diseases. This includes the introduction of low molecular weight heparins, thrombolytic therapy, and the recognition of the hypercoagulable states. A large portion of this book is dedicated to the thrombotic disorders and their therapy. It's a free and safe download via adrive HERE
Another useful website is available HERE

Consultancy hired by Omrix to Assess Fibrin Patch

Omrix, as you know are conducting a trial for a fibrin pad, which at a selling point of $500 will enter the market 2008 with US unit sales of 20,853 capturing 20% of the market share (according to the 2005 un-updated report at Omrix website, link below). This is expected to grow to a peak of 70% of the market by 2013.
While EMS and military use is apparently not the main focus for sales, it appears the US market is the main target further aimed at "less price sensitive" surgeons.
I am sure Ethicon must be preparing for a mighty unveiling and market entry, still one wonders whats going on with this talk of J&J woundcare sale? For Ethicon the Fibrin pad is probably a good strategy for moving some of that human sourced Evithrom (another Omrix thrombin product). As the recently funded $100 million for Zymogenetics with their recombinant product recothrom hits the stage.
Patch revenues are estimated to total over half a billion dollars within 10 years of launch. Further figures mentioned estimate the European market at 50% of the US and the ROW at 45% of the US market. Similar growth is anticipated in Europe and ROW as Stateside.
The full Pdf is available at the Omrix site or HERE is a link.

Closure Medical not part of J&J woundcare sale

Johnson & Johnson's plans to sell its professional wound care business won't affect Raleigh-based Closure Medical Corp. Closure Medical, which has about 120 workers, became part of J&J's Ethicon subsidiary in 2005 after agreeing to a $370 million takeover. Closure produces Dermabond and other surgical glues. Ethicon announced Tuesday that its unit that produces dressings for wounds is being acquired by a private equity firm, One Equity Partners, for an undisclosed price. But its wound closure business, which includes Closure, isn't part of that deal, said Ethicon spokeswoman Jackie Russo-Jankewicz.
In 2007 the Professional Wound Care business had annual sales of about $270 million but terms of the financial transaction have not been disclosed.
Brands included in the Professional Wound Care product portfolio include:

• PROMOGRAN® Matrix Wound Dressing;
• TIELLE® Hydropolymer Dressing;
• REGRANEX® (becaplermin) Gel 0.01%, a prescription treatment for lower extremity diabetic ulcers; and
• A portfolio of general wound care products.

Omrix/Ethicon Fibrin Pad Trial

Omrix Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI) announced today that it has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate. This is the first clinical trial that will evaluate the Fibrin Pad’s performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ. The Phase II clinical trial in Israel is being conducted simultaneously with the Phase II clinical trial in the U.S., which commenced on March 27, 2008 and is under an Investigational New Drug (IND) application that was filed with the Food and Drug Administration (FDA) in November 2007.
The Fibrin Pad is a breakthrough convergence product candidate comprised of biological components in a biodegradable device. In collaboration with ETHICON, INC., a Johnson & Johnson company, the Fibrin Pad is being developed for the management and rapid control of mild, moderate and severe bleeding.

Johnson & Johnson is considering selling its wound-care business

Johnson & Johnson is considering selling its wound-care business to a private equity group, One Equity Partners. I don't think Johnson & Johnson's investors should really care one way or another; the unit's $270 million in sales last year made up less than 1% of Johnson & Johnson's revenue. But investors in picking Omrix Biopharmaceuticals should pay very close attention to the deal.
Johnson & Johnson's wound-management division markets all of Omrix's biosurgical products, and the two are also working together to develop a fibrin patch that combines a physical barrier with a biologically active component to stop bleeding.
The health-care conglomerate has until Aug. 22 to decide whether it will accept the offer for an undisclosed amount of money. (You can get away with these types of vague press releases when you're as large as Johnson & Johnson.)
Unsurprisingly, there's not quite enough information in the press releases and 10-Ks to know exactly what will happen, but let's check out the possibilities:

• Johnson & Johnson retains the right to sell Omrix's products, even though it's selling off its wound management business. That doesn't sound like the best option for Omrix, since having the sales reps hocking related wares likely helps move Omrix's own products.
• The partnership transfers to the new owners unchanged. This would be a big unknown for Omrix; One Equity could provide additional support for Omrix's products, but the backing of Johnson & Johnson sure sounds a lot better.
• A change in ownership allows Omrix to break out of the partnership. This could be an advantage to Omrix, if it can get a better deal from another company that sells wound management products, like Kinetic Concepts or Covidien.

Johnson & Johnson hasn't been doing terribly well against ZymoGenetics and King Pharmaceuticals in the battle of the thrombins since Omrix's version came on the market last year. But it has been doing a good job pushing Omrix's Evicel -- its fibrin sealant used to stop surgical bleeding. If J&J does decide to bid Omrix adieu, it'll likely do so with mixed feelings.

Source: Motley Fool

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.