Fibrin glue deal talks stalled / Plaintiffs claiming substance caused hepatitis infections uncompensated

Settlement talks have reached an impasse for plaintiffs involved in lawsuits against the government over claims they were infected with the hepatitis C virus after being administered fibrin glue during surgery.
The government has cited that a causal link is unclear between the glue, a compound of fibrinogen and other substances used as a surgical adhesive for stitches made in heart and other types of surgery, and the hepatitis infections.
Since the January enactment of a special measures law to provide compensation to patients, about 600 plaintiffs have reached a settlement with the government. The plaintiffs who received state compensation were infected with the virus after being administered with a fibrinogen blood product.
However, the vast majority of plaintiffs claiming they were infected by the virus after being administered fibrin glue have yet to be compensated.
So far, only four such plaintiffs have reached a settlement with the government, according to a national group of lawyers representing hepatitis C victims that were infected by the virus through tainted blood products.
This leaves about 160 plaintiffs who have been unable to claim what the government says are blanket relief measures.
A 27-year-old man from Kanagawa Prefecture was diagnosed with acute hepatitis after a heart operation when he was 5. His condition is now chronic.
For many years, he did not know what the source of his infection was, but in light of the many media reports on the issue of hepatitis caused by tainted blood products, he made an inquiry to the hospital that operated on him at the end of last year and learned that fibrin glue was used in his surgery.
He brought a case against the government in April, but no progress has been made toward reaching a settlement.
A doctor recommended that he undergo interferon treatment, which is known to be effective for hepatitis C sufferers. But treatments costs several tens of thousands of yen a month, and the man lacks the funds to pay for it.
"The glue may have saved my life, and I bear no grudge against the hospital," the man said. "But I can't think of anything else that could have caused the infection, and I want the government to compensate me soon."
Fibrin glue is believed to have been administered to about 79,000 people in the 1980s.
But the glue is applied to incisions and wounds and differs from fibrinogen, which is used as a hemostatic agent and administered by intravenous injection.
The government has said "the infection rate is unclear because [fibrin glue] is not injected directly into blood vessels."
Settlements have only been reached so far with individuals whose infection is clearly linked to the application of the glue.
"By March, we hope to collect scientific data and establish fixed criteria for settlements," a Health, Labor and Welfare Ministry spokesman said. "Should a clear causal link be found, we'll swiftly begin settlement procedures."
The lawyers group says it has confirmed cases of infection from the use of minute quantities of the glue, and on Friday submitted a written demand to five district courts at which lawsuits are in progress--those in Tokyo, Osaka, Nagoya, Fukuoka and Sendai.
"The glue's danger is clear," the demand states. "[The government] should reach settlements as quickly as possible."

CPC Adds Key Bench Strengths to Medical and Technical Advisory Team

CPC of America, Inc. (OTCBulletinBoard: CPCF.OB) , a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced the addition of three medical and technical advisors to its team. Dr. Olexander Hnojewyj, Dr. James L. Rogers and Richard E. Anderson will add strategically important bench strengths to the team's expertise as they work to develop MedClose(TM), an investigational*-stage vascular closure system (VCS) that is intended to seal the femoral arterial puncture site following diagnostic or interventional catheterization procedures. Information on CPC's advisory team can be found at CPC's enhanced corporate Web site, CPCMedDevices.com.

Merry Christmas and Seasons Greetings

To All Readers I would just like to pass on my thanks for your support over the past year.

So to all Merry Christmas and a Happy New Year!!!

St Jude Medical acquires Radi Medical Systems for $250 million

US-based St Jude Medical has completed the acquisition of Sweden-based Radi Medical Systems for $250 million in cash.
With this transaction, Radi Medical Systems will become part of the St Jude Medical cardiovascular division. The transaction is expected to be neutral to St Jude Medical's consolidated earnings per share in 2009 and is expected to be positive to consolidated earnings per share beginning in 2010.
St Jude Medical funded the acquisition with cash on hand outside the US as well as with the proceeds from a new three-year term loan established recently with a syndicate of banks.
In connection with the transaction, Banc of America Securities acted as financial advisor to St Jude Medical, and Sidley Austin and Mannheimer Swartling Advokatbyra are serving as legal counsel to St Jude Medical and Katsky Korins and Advokatfirmen Lindahl are serving as legal counsel to Radi Medical.
Daniel Starks, chairman, president and CEO of St Jude Medical, said: "This acquisition will accelerate the expansion of St Jude Medical's cardiovascular growth platform and benefit the customers, employees and shareholders of both companies. We look forward to capturing strategic synergies through this acquisition and further expanding our investment in our cardiovascular division technology, products and programs."
Thomas Engstrom, CEO of Radi Medical Systems, said: "We are pleased to join with the industry leader in active vascular closure and a partner who shares our vision of developing innovative cardiovascular technologies that improve patient care. This transaction brings together complementary product lines and, through St Jude Medical's sales and distribution infrastructure, extends our reach to even more physician customers for the benefit of the patients they help everyday."

Committee For Medicinal Products For Human Use Post-Authorisation Summary Of Positive Opinion For Tachosil

LONDON, Dec. 18, 2008-On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product TachoSil. The Marketing Authorisation Holder for this medicinal product is Nycomed Austria Gmbh.
The CHMP adopted new indications as follows: “to promote tissue sealing and for suture support in vascular surgery”.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for TachoSil will be as follows***: TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient (see SPC section 5.1)”.

* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.

** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.

Surgical sealant developer sues Omrix

Prof. Uri Martinovich has filed a NIS 3.43 million lawsuit with the Tel Aviv District Court against Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) and its president and CEO Robert Taub for allegedly deprived him of his patent rights to the biological sealant that the company produces. Martinovich is the director of the National Hemophilia Center at Sheba Medical Center Tel Hashomer.
In November, Johnson & Johnson (NYSE: JNJ) acquired Omrix for $438 million. On Friday, Antitrust Authority director general Ronit Kan approved the acquisition, under the Restrictive Trade Practices Law (5748-1988). Taub founded Omrix in 1994.
Martinovich claims that he developed the compound for the biological sealant, but was deprived of his patent rights. He also claims that he was not paid for his invention or for the thousands of hours he spent developing it over ten years. He claims that Omrix violated agreements under which it promised to pay him $1.4 million for the rights to the invention.
Martinovich claims that Omrix paid him only $750,000, but that it refused to pay the $650,000 balance or to give him agreed-upon stock options. He is demanding payment of the amounts he claims he is owed, and to be sold 20,000 shares at $6 per share.
Omrix and Taub have not yet filed a statement of response.
Omrix closed at $24.90 yesterday, giving a market cap of $426 million.
There have been several cases in Israel in recent years in which inventors sued companies for allegedly depriving them of their rights. Cases include collagen-based matrices developer ColBar LifeSceiences Ltd. (which was acquired by Johnson & Johnson unit Ortho-McNeil Pharmaceutical, Inc. in 2006) and miniature implants developer Remon Medical Technologies Ltd.

Avigen Sells Early Stage Research Program in Hemophilia to Baxter

ALAMEDA, Calif., Dec 18, 2008 (GlobeNewswire via COMTEX) -- Avigen, Inc., a biopharmaceutical company, announced today that the company has sold the rights to its early stage blood coagulation compound, AV513, to Baxter Healthcare Corporation, a global leader in hemophilia therapy, for $7 million. Baxter acquired all rights to AV513, a compound poised for clinical research that has been shown to improve blood coagulation in preclinical models for hemophilia. Avigen has been developing AV513 as an oral therapy to treat patients with bleeding disorders, including hemophilia A.
"The sale of AV513 is an example of building value in a product that is differentiated from current therapies, and bringing it to a valuation point that generated a positive return on investment," said Kenneth Chahine, Ph.D., J.D., Avigen's president and chief executive officer. "Our team identified AV513 as a drug candidate with a novel approach for treating hemophilia and other bleeding disorders, and which offered strong IP potential in a target patient population with an unmet need. Because it was outside our neurology focus, it was our goal to follow a reasonable budget to establish AV513's value, and then move it to a better-resourced company with the expertise to develop a safe and effective therapy."
"This technology acquisition supports Baxter's efforts to research the application of novel technologies that will pioneer the next generation of hemophilia therapies," said Hartmut Ehrlich, M.D., vice president of global BioScience research and development for Baxter.

Israeli regulators approve Johnson & Johnson-Omrix deal

Healthcare company Johnson & Johnson said Thursday that it has received antitrust approval from the Israeli General Director of the Antitrust Authority for its proposed acquisition of Omrix Biopharmaceuticals Inc.
Last month, Johnson & Johnson agreed to buy Omrix, which develops and markets biosurgical and immunotherapy products, for about $438 million in a cash tender offer.
Under the deal, Johnson & Johnson commenced a tender offer to buy all outstanding shares of Omrix at $25 per share, which is expected to close by the end of December 2008.
The acquisition, which has the approval of the boards of directors of both companies, is expected to be breakeven to slightly dilutive to Johnson & Johnson's earnings per share in 2009.
Following the acquisition, New York-based Omrix will operate as a stand-alone entity reporting through Ethicon, Inc., a Johnson & Johnson company that provides suture, mesh, hemostats and other products for surgical procedures.

ZymoGenetics Presents Favorable RECOTHROM® Phase 3b Results

ZymoGenetics, Inc. (NASDAQ: ZGEN) presented positive results today from a Phase 3b clinical trial with RECOTHROM® Thrombin, topical (Recombinant). The study provided additional information about the immunologic safety of RECOTHROM and demonstrated that RECOTHROM was well tolerated when applied as an aid to hemostasis in patients, including those with pre-existing antibodies to bovine thrombin.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”
The Phase 3b open-label, single-group, multisite study evaluated the immunogenicity and safety of RECOTHROM among 205 subjects who were at increased risk for having anti-bovine thrombin product antibodies as a result of prior surgery with a high likelihood of bovine thrombin exposure. Topical RECOTHROM was applied during a single spinal or vascular surgical procedure. Immunogenicity was evaluated by enzyme-linked immunosorbent assay at baseline and Day 29. At baseline, 173 subjects (84%) were seronegative and 32 (16%) were seropositive for anti-bovine thrombin product antibodies.
At the end of the study, no patients had developed antibodies against RECOTHROM. The immunogenicity profile of RECOTHROM did not differ among patients who entered the study with or without pre-existing antibodies to the bovine thrombin product.
RECOTHROM was well tolerated and observed adverse events (AEs) were consistent with those commonly seen in post-surgical settings. The most common AEs (reported by 10% or more of subjects) included incision site pain, procedural pain, nausea, constipation, anemia, muscle spasms, hypotension, and pyrexia. The safety results in this study were consistent with those observed in previously reported clinical trials with RECOTHROM.
RECOTHROM is being commercialized by ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.

50th Annual Meeting of the American Society of Hematology

SAN FRANCISCO, Dec 03, 2008 /PRNewswire-USNewswire via COMTEX/ -- The American Society of Hematology (ASH), the world's largest professional association of blood specialists, expects more than 20,000 attendees at the 50th ASH Annual Meeting from December 6-9, 2008, at the Moscone Center in San Francisco, CA. The meeting will showcase the latest research and treatments for blood disorders. In honor of the Society's golden anniversary, there will also be several special programs including a unique video project featuring influential figures in hematology.
"It is my distinct honor to serve as President during this celebratory year in the Society's history. The ASH annual meeting continues to be the premier forum for physicians and researchers from around the world to hear the most up-to-date developments in hematology, and this year will be no exception," said Kenneth Kaushansky, MD, 2008 ASH President, and Helen M. Ranney Professor and Chair of the Department of Medicine at the University of California, San Diego School of Medicine. "In addition to presenting research that affects hematologists in every area of the discipline, this year's meeting underscores 50 years of unprecedented growth and advancement in the field."
Highlights of the meeting include special symposia, education programs, special interest seminars, and scientific sessions. As part of the 50th anniversary celebration, the meeting will also feature historical displays showcasing major scientific discoveries and clinical advances in the specialty. Several world-renowned scientists will share their life stories and speak about groundbreaking medical discoveries during the Pioneers in Hematology sessions.
The Special Symposium on the Basic Science of Hemostasis and Thrombosis will provide an opportunity for communication among scientists in the field and focus on the most important basic science contributions from 2008 to each of the three major areas of the field: thrombosis, blood coagulation and fibrinolysis, and platelet biology. In September, the Surgeon General's Call to Action to Prevent and Reduce Deep-Vein Thrombosis and Pulmonary Embolism encouraged public awareness of this blood condition that affects nearly 1 million Americans each year. The symposium will take place on Tuesday, December 9, from 7:30 - 9:00 a.m. PST.
This year's Practice Forum, "The Patient, the Hematologist, and the Unexpected," will focus on two areas of unexpected results encountered commonly enough to raise the interest of the hematology community. Additionally, this session will look at the public policy environment that will shape the practice of hematology and the Society as it enters its 51st year. This event will take place Saturday, December 6, from 6:00 - 7:30 p.m.
Another highlight of the meeting is the Presidential Symposium, which will focus on hematopoietic stem cells (HSCs). These cells are known for their role in the cure of a variety of diseases as well as for providing an understanding of stem cell development in all mammalian biology. During the symposium on Tuesday, December 9, from 9:45 - 11:45 a.m., three eminent investigators who have made significant contributions to our understanding of HSC biology will discuss the properties of these cells and their role in the human body.
Neal S. Young, MD, of the National Heart, Lung, and Blood Institute, National Institutes of Health, will discuss the pathophysiology of bone marrow failure and how clinical observations of patients with this disease have provided insights into the biology of autoimmunity, viral pathogenesis, and cancer at this year's E. Donnall Thomas Lecture on Monday, December 8, from 9:30 - 10:30 a.m. Bob Lowenberg, MD, Ph.D., of the Erasmus University Medical Center in the Netherlands, will give the Ham-Wasserman Lecture on Saturday, December 6, from 12:30 - 1:30 p.m. Dr. Lowenberg's lecture will focus on the numerous genetic abnormalities found in acute myeloid leukemia patients and ways to use this information to develop individualized therapies. Both the E. Donnall Thomas Lecture and the Ham-Wasserman Lecture represent areas of medicine that have evolved immensely over the last 50 years.
This year's plenary policy forum, "50 Years of Progress in Hematology," which is co-sponsored by ASH and the European Hematology Association, will feature Nobel Prize winner Peter Agre, MD, who will discuss how his research on water channels in red blood cells, as well as the research of others that originated in hematology, grew to have profound and catalytic influences on numerous areas of science.
For the complete annual meeting program and abstracts, visit www.hematology.org.

Study: Terumo TR Band™ Hemostasis Device Reduces Radial Artery Occlusion by 56%

A new study, conducted by Dr. Samir B. Pancholy of Mercy Hospital in Scranton, Pennsylvania, shows that the concept of "guided compression" in transradial procedures can reduce radial artery occlusion by 56%, especially when facilitated by the use of the TR Band™ Hemostasis Device.
While infrequent (in the single digits), radial artery occlusion is a discouraging complication of radial artery access.
Although it is usually benign for the patient, it precludes future radial access. For example, if the radial artery occludes after a diagnostic catheterization, any subsequent PCI procedures must be done via the femoral artery.

But there are a number of methods for achieving hemostasis in a radial procedure. Pancholy looked at data from his own lab and saw that patients on whom he had used the TR Band, as opposed to the commonly-used HemoBand, had significantly lower rates of radial artery occlusion. So Dr. Pancholy devised a randomized clinical study to test the efficacy of the TR Band in preventing radial artery occlusion.
500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of HemoBand (Group I) and the next 250 patients received hemostasis using the inflatable TR band (Group II). Radial artery patency was studied the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hour and 30 days using Barbeau’s test.
The results were that 28 patients in Group I (11.2%), developed evidence of early occlusion (at 24 h), compared to 11 patients (4.4%) in Group II (P<0.005).>

Starch Medical Launches New, Bioinert Surgical Hemostats

SAN JOSE, Calif., Dec. 2 /PRNewswire/ -- Starch Medical Inc, a San Jose, CA-based medical device manufacturer, announces the CE approval of its PerClot(TM) Polysaccharide Hemostatic System (PHS) and the StarFoam(TM) Absorbable Polysaccharide Hemostat. Introduction of PerClot(TM) PHS will commence this month in the European Union and other select international markets. The StarFoam(TM) Absorbable Polysaccharide Hemostat will launch during the 2nd quarter, 2009.
PerClot(TM) PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP(TM)). AMP(TM) technology incorporates sophisticated, plant-based polymer modification processes that yield biocompatible, polysaccharide particles. There is no thrombin, collagen, or other human or animal components in AMP(TM) particles. A family of customized, single-use application instruments will enhance the delivery of AMP(TM) to the wound site for the control of capillary, venous and arterial bleeding in both open and minimally invasive surgical procedures.
The StarFoam(TM) Absorbable Polysaccharide Hemostat, also developed with AMP(TM) technology, is produced in a hemostatic foam (wafer) configuration. Application of StarFoam(TM) will feature a simple "press and release" technique.
David Lang, President of SMI, commented, "The clinical introduction of PerClot(TM) PHS and its proprietary, integrated AMP(TM) technology represents the next generation of polysaccharide hemostatic agents. The StarFoam(TM) product line will offer surgeons a choice of hemostatic formats for a range of surgical wounds. Compared to current polysaccharide based hemostats, PerClot(TM) PHS and StarFoam(TM) demonstrate superior hydrophilic action and enhanced adhesive strength. These performance features, coupled with custom delivery systems, have been favorably received in a diverse range of surgical applications in Europe, Asia and Latin America."
SMI is a privately-held medical device company engaged in the design, manufacture, marketing and licensing of breakthrough, hemostatic solutions. Starch Medical's proprietary, patent-pending technology platform (AMP(TM)), including powders, foams and films, will focus on the worldwide, multi-billion dollar biomaterial, hemostasis, and wound care marketplace. For additional information, distribution inquiries, and licensing options, visit http://www.starchmedical.com/.