Omrix, a Johnson & Johnson unit, obtains FDA approval for fibrin sealant

Johnson & Johnson (NYSE: JNJ) unit Omrix Biopharmaceuticals Ltd. has obtained US Food and Drug Administration (FDA) approval for its fibrin human sealant patch, one of Omrix's most interest products and the reason why Johnson and Johnson acquired it for $438 million in 2007.

The product, now called Evarrest, is based on Omrix's biological sealant for stopping problematic bleeding during surgery. "Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%," says Ethicon Biosurgery (the J&J division which includes Omrix) in its press release.

Omrix's biological sealant is currently used to stop bleeding during surgery or from wounds, but the Evarrest patch Evarrest is easier to use. To stop bleeding, the surgeon places the sealant over the wound and manually compresses it in place for three minutes. The sealant becomes part of the body, gradually degrading over several days or weeks.

The sealant is based on the production of clotting substances in human blood plasma. Ethicon Biosurgery says, "Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard of care at 53%, potentially minimizing disruption to the surgical procedure."

The FDA approval is good news for Johnson & Johnson and for Israel's life sciences industry, and the company will produce Evarrest in Israel, at least over the next few years.

Johnson & Johnson unit Ethicon Inc., which is responsible for hemostasis and sealing solutions to which Omrix belongs, is also considering other options for producing Evarrest and other products later on. It is in talks with Swiss's Octapharma AG, founded by Omrix founder Robert Taub, for this purpose. Omrix was a spin-off of Octapharma, a producer of human plasma products.

In 2009, the State of Israel sued Omrix's founders and Johnson & Johnson for not paying royalties on the acquisition of the intellectual property of the inventor of Omrix's products, a doctor at Sheba Medical Center Tel Hashomer. Omrix and Johnson & Johnson say Omrix was responsible for most of the invention, or that which it received it from Octapharma. The case is still pending, and while it has not yet affected Ormix's thriving operations in Israel to date, it may affect them in the future.

J&J's EVARREST Fibrin Sealant Patch Approved by FDA

Ethicon Biosurgery, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved EVARREST™ Fibrin Sealant Patch, a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery.  Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%.

EVARREST™ has been indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery, when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.  It is not for use in children under one month of age and it cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.

"The FDA approval of EVARREST™ is a significant milestone in advancing patient care.  We believe this technology has the potential to drive a paradigm shift in the treatment of problematic bleeding during surgery," said Dan Wildman, Worldwide President, Ethicon Biosurgery.  "EVARREST™ combines the company's expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."

EVARREST™ consists of a coating of biologics and a flexible patch that, when combined, form a distinct delivery system that will raise the standard of care for surgeons and their patients.  Each component of EVARREST™ ^ plays an active role in the hemostasis process -- the biologics (human thrombin and fibrinogen) react and initiate a fibrin clot, which then integrate into the patch, providing mechanical support and adherence to the wound site.

To use the product, surgeons place EVARREST™ upon the bleeding wound surface and apply manual compression for approximately three minutes.  EVARREST™ remains in the patient's body once surgery has been completed as it is fully bio-absorbable.

Wellcome Trust and investors back £2.2million clinical development of new haemostat to control surgical bleeding

31st October 2012 - Haemostatix Ltd, a biopharmaceutical company, announced today that it has received an additional £1.4 million Translation Award from the Wellcome Trust to continue development of its innovative haemostat technology. The funding coincides with a further £800,000 investment from Albion Ventures, Catapult Venture Managers, Spark Ventures, Esperante, Nesta, the Lachesis Fund, The University of Leicester and private share-holders. The new funds will enable Haemostatix to progress its lead product, PeproStat, into clinical trials.

PeproStat is a new class of peptide-based haemostat that controls bleeding by binding to the blood protein, fibrinogen, to rapidly form a clot. Haemostats are used by surgeons to manage problematic bleeding and to reduce time in the operating theatre during surgery. Current haemostatic products may be limited by a slow onset of action as well as a lack of “ready-to-use” formulations. Additionally leading brands are based on an enzyme, thrombin, that is extracted from human donor blood. PeproStat has been designed to overcome these limitations, and the clinical trial will test the product’s safety and effectiveness in man.

Dr Ben Nichols, CEO of Haemostatix, commented: “There is a real need for rapid acting, ready-to-use haemostats that are safe and cost-effective, and we believe our technology can deliver these benefits to surgeons and their patients. This Award and the share-holder investment, will enable us to generate more data to support the translation process from research to patients.”

Dr Richard Seabrook, Head of Business Development at the Wellcome Trust, said: “Improved control of bleeding is vital for safe and effective surgical procedures. We are pleased to offer our continued support to this project and look forward to seeing the technology advance towards clinical use.”

Haemostatix is based at BioCity Nottingham in the City’s new Creative Quarter. The company was originally a spin-out from the University of Leicester, and continues to collaborate with the University on fundamental research to underpin its product development programme.

Baxter (BAX) To Expand Access To Recombinant FVIII Hemophilia Treatment In Brazil

Baxter International Inc. (NYSE: BAX) announced an exclusive 20-year partnership with Hemobrás (Empresa Brasileira de Hemoderivados e Biotechnologia) to expand greater access to recombinant factor VIII (rFVIII) therapy for the treatment of hemophilia A in Brazil.

Hemophilia A is a genetic condition in which the body does not produce enough clotting protein factor VIII. It is estimated that more than 10,000 people in Brazil are living with hemophilia A, and today the vast majority are treated with plasma-derived FVIII therapy.

Recently, Baxter highlighted the importance of developing innovative business models, including public and private partnerships, aimed at improving the quality of and access to care in both developed and emerging markets.

Through this innovative partnership, Baxter will be the exclusive provider of Brazil's recombinant FVIII treatment over the next 10 years while the companies work together on the technology transfer to support development of local manufacturing capacity by Hemobrás.

Baxter will receive cash payments for product it supplies to Hemobrás and, following completion of the technology transfer, royalties on recombinant FVIII produced by Hemobrás. The company expects peak annual sales to exceed $200 million.

''Our unique collaboration with Hemobrás is a demonstration of Baxter's leadership in hemophilia, reflects our expertise and commitment to the community, and positions us as an attractive partner that can make a significant impact on expanding access to quality care to patients around the world,'' said Robert Parkinson Jr., chief executive of Baxter.

Cohera Medical's TissuGlu surgical adhesive product receives US FDA approval

Cohera Medical, Inc., a leading innovator and developer of absorbable surgical adhesives and sealants, has received approval from the United States Food and Drug Administration (FDA) for the first of four modules of the company’s PMA filing plan for its TissuGlu Surgical Adhesive product.

Earlier this year, the company received approval of its modular approach to filing the PMA from the FDA, and submitted the first module pursuant to this plan.

The first module contained the pre-clinical testing profile for TissuGlu including extensive biocompatibility and toxicological testing information. The company expects to file the second module containing information related to the characterization and specifications of TissuGlu before the end of the year, and the remaining two modules describing the manufacturing, quality system and clinical study information in 2013.

“We are pleased to receive FDA approval for the first module of the PMA in which the biocompatibility and pre-clinical testing profile of TissuGlu is acceptable,” said Chad Coberly, JD Vice President of Clinical, Regulatory and Legal affairs of Cohera Medical. “We appreciate the professional and interactive review by the FDA for this module and look forward to working with the Agency on the review of the future modules.”

“The first module approval of the TissuGlu PMA is another significant milestone for Cohera and its investors,” said Patrick Daly, president and chief executive officer of Cohera Medical. “The approval for this information confirms the basic safety profile of this important new product and allows the Company to proceed with its modular PMA filings on plan.”

Cohera Medical recently received CE Marking approval for TissuGlu and began selling product to hospitals and surgeons in Germany in September 2011. The company plans to expand the commercial availability of TissuGlu in 2012.

Free Interactive webinar on haemostasis

An interactive webinar for trainees on haemostasis and the structure and function of haemoglobin is being held on Tuesday October 23.

The webinar is for trainees preparing for the ANZCA primary examination and is being held at 7.30pm (AEST). All that is required is a computer with speakers and an internet connection.

For more information, click HERE.

EMMC program to reduce blood transfusions draws international interest

BANGOR, Maine — Eastern Maine Medical Center is hosting physicians and researchers from abroad this month who are interested in the hospital’s work to reduce unnecessary blood transfusions.

On Monday, a team from western Australia visited Bangor for a hands-on introduction to EMMC’s “patient blood management program,” which began in 2007 as an effort to cut down on avoidable blood transfusions. On Sept. 24, a team from Switzerland will visit the hospital to learn about the program.

EMMC has reduced the number of blood transfusions it performs by 60 percent since 2006, according to Dr. Irwin Gross, medical director of transfusion services at the hospital.

In some cases, transfusions can save lives, such as by replenishing the blood lost by severely injured trauma patients, he said. But transfusions aren’t always necessary for some conditions and can lead to complications.

The risks associated with blood transfusions have traditionally centered on patients’ exposure to diseases, such as hepatitis and HIV, Gross said. In recent years, however, with the blood supply widely considered safe, the concerns have shifted to research indicating that transfusions are associated with longer hospital stays and greater risk of hospital-acquired infections and other complications, he said.

EMMC has cut down on unneeded transfusions by screening patients for anemia before they arrive for procedures such as hip and knee replacements, Gross said. By treating the condition — a lack of healthy red blood cells in the body — ahead of time, surgeons often can avoid the need for a transfusion.

“Once [patients] are here, we use medications and surgical techniques to try to minimize the amount of blood that’s lost,” he said.

While orthopedic procedures such as joint replacements often involve blood transfusions, the procedure is actually more common in nonsurgical hospital admissions, particularly among cancer patients, Gross said.

The hospital also has integrated the blood management strategies into its electronic medical records system, which helps doctors to make better decisions about when transfusions are necessary while reviewing patients’ histories, Gross said.

The team from western Australia, which is visiting EMMC through Wednesday, is interested in developing a blood management program across a number of hospitals in their region, he said. The group from the University Hospital Zurich, visiting next Monday, plans to do the same within their hospital, Gross said.

Childhood Coagulation Marker Levels Distinct From Adulthood

Levels of key coagulation markers significantly vary with age in children, research reveals, potentially affecting the diagnosis and treatment of pediatric thrombotic and hemorrhagic disease.

Young children have significantly lower levels of fibrinogen and factor (F)II, IX, XI, and XII than older children, the researchers report in the Journal of Thrombosis and Haemostasis.

Younger age was also associated with significantly lower levels of Protein C and Protein S, but higher concentrations of D-dimer.

Von Willebrand factor (vWF) levels were also elevated in the first year of life, but there was no associated increase in FVIII levels, expected due to the known impact of vWF on FVIII half life.

vWF levels fell to a nadir at 1 year and then gradually increased to adult levels, but this trend was dependent on blood group type. Blood group O carriers showed only a slight increase from a median of 66% to 88% of adult levels, versus a median 106% in non-O blood group carriers.

The researchers believe this may be due to the increased susceptibility of vWF of blood group O to the proteolytic activity ofADAMTS13 compared with non-O blood groups. In the first months of childhood, when A, B, and H antigens of vWF are low, there may be less pronounced blood group differences in vWF levels.

"Our results underline the need for age-specific reference ranges," write Inge Appel and co-workers, from Erasmus Medical Centre - Sophia Children's Hospital in Rotterdam, the Netherlands.

The greatest variation was between infants in the first year of life versus adults, but inter-individual variability in coagulation factors was highest in the youngest children. The researchers therefore recommend: "In neonates and infants multiple reference samples are required to define the normal range in coagulation proteins for age more precisely."

The team examined blood samples from 218 healthy children aged 1-6 months (n=29), 7-12 months (n=25), 1-5 years (n=57), 6-10 years (n=57), 11-18 years (n=50), and over 19 years (n=52) using two different analyzers; the Behring Coagulation System (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany) and the CA-1500 system (Sysmex, Kobe, Japan).

There was good correlation between the two systems for all coagulation markers, except prothrombin and activated partial thromboplastin time.

Alok Khorana To Head ISTH Subcommittee

Pittsford N.Y. resident Alok Khorana, M.D., vice chief of the Hematology/Oncology division at the James P. Wilmot Cancer Center, has been appointed chairman of the Hemostasis and Malignancy Subcommittee of the International Society of Thrombosis and Haemostasis (ISTH). 

The appointment signifies Khorana’s growing reputation as a global authority on thrombosis and other blood disorders.

In his new leadership role, Khorana will be responsible for the Subcommittee's 2013 program of work, primarily the 2013 Scientific Subcommittee Meeting, which will take place in conjunction with the 24th ISTH Congress in June in Amsterdam. Khorana is tasked with proposing educational topics and speakers for the session.

Khorana, who is also an associate professor of Hematology/Oncology in the Department of Medicine, has been at the Cancer Center since coming to the University of Rochester Medical Center as a fellow in Hematology/Oncology in 1999.

Baxter Submits Application for FDA Approval of Recombinant Factor IX for the Treatment of Hemophilia B

DEERFIELD, Ill. - Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.

Hemophilia B, also known as Christmas disease, is the second most common type of hemophilia and results from insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding. 1 Approximately 25,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. 2

The BLA filing is based on results from a global Phase III study conducted in 10 countries around the world. The prospective, controlled, multicenter study evaluated the pharmacokinetics, efficacy, safety and immunogenicity of BAX 326 in 73 patients with severe or moderately severe hemophilia B previously treated with other factor IX therapy. The study met its primary objectives and the company plans to present the complete data from the study in late 2012. Baxter expects to file its application for BAX 326 in Europe in 2013.

"Hemophilia B patients have relatively limited options for their treatment today, with only one commercially available recombinant (genetically engineered) protein. As part of our long-standing commitment to the hemophilia community, we continue to pursue new potential treatment options like BAX 326 to support patients with this debilitating disease," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business.

In select countries, Baxter currently offers a plasma-derived factor IX treatment, Immunine [Factor IX Concentrate (Human)], for patients with hemophilia B, which has more than 16 years of patient experience in Europe and Latin America. In addition, Baxter recently announced a partnership with Chatham Therapeutics, LLC to develop a gene therapy based treatment for hemophilia B. Gene therapy could represent another important first for the community as an innovative potential therapy for hemophilia B treatment.