ProFibrix Phase III Trial with FibrocapsTM (FINISH-3) Passes Important Safety Milestone & Almost Completes Enrolment

LEIDEN, The Netherlands & SEATTLE -- 

ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.

To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to complete enrolment have already been recruited into the study. Two of the four surgical indications, spinal and soft tissue surgery, completed enrolling. Full enrolment is expected to be completed in April 2013 and final results from the study are anticipated in June 2013.

Jan Öhrström, Chief Executive Officer of ProFibrix said: “The positive review by the DMC bodes well for our filings with U.S. and EU authorities in the fall of 2013. Furthermore, the strong support of the investigators involved in FINISH-3 has resulted in an amazing speed of enrolment. This strengthens our belief that Fibrocaps has the hallmarks to capture a significant part of the fast growing USD 1 billion topical hemostat market.”

About Fibrocaps

Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the FINISH-3 trial

FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control for the treatment of mild to moderate bleeding in 672 subjects undergoing spinal, liver, vascular and soft tissue surgery (n=168 in each indication), conducted at 65 sites across Europe and the U.S.

MDCO, Bristol-Myers Squibb begin global alliance for Recothrom

The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective. The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions. Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We believe that completing this deal is another step to establish The Medicines Company as a leader in acute and intensive care medicine globally." Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin) and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as "active" hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats and fibrin sealants. Recothrom was approved in the United States in January 2008 and in Canada in December 2010. The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide.

J&J's Ethicon recalls blood-stopping hemostat; FDA warns of deadly risk

Johnson & Johnson unit Ethicon is recalling its some of Surgiflo hemostatic kits, warning that a packing issue could lead to breaches in the product, and the FDA has assigned its most serious label to the recall.

Surgiflo is a topical, absorbable hemostat used to stop bleeding in surgical procedures. Ethicon became aware of the packing problem back in the spring and is urging customers to return the affected lots once they're identified. The FDA has branded the affair a Class I recall, saying the recalled products could be rendered non-sterile and their use could to lead to serious injury or death.

Ethicon says it is yet to receive any reports of adverse events from Surgiflo, but the FDA is asking customers to report any problems through its online MedWatch system.

Ethicon has a long history of regulatory dustups, including the costly and deadly vaginal mesh debacle and an October Class I over malfunctioning surgical staplers. However, the company last week won FDA approval for its Evarrest Fibrin Sealant Patch, and J&J has committed to spending $185 million to expand Ethicon's suture-making plant in Athens, GA.

- Here's the FDA's notice

The Medicines Company and Bristol-Myers Squibb Agree to Global Alliance For Recothrom

The Medicines Company builds on portfolio and capabilities in acute and intensive care hospital medicine with marketed perioperative biologic

Parsippany, NJ, and Princeton, NJ, USA I December 12, 2012 I The Medicines Company (NASDAQ:MDCO) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have signed a global license and two year collaboration for Recothrom®, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

Clive Meanwell, M.D., Ph.D., Chairman and CEO of The Medicines Company said, “As a marketed, growing product to control blood loss in the hospital, we believe Recothrom is a strategic fit that enables operating leverage with The Medicines Company’s emerging perioperative care portfolio. The financial structures and net revenues fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine. Of course, thrombin is also a hemodynamic target we know well based on our experience with Angiomax® (bivalirudin), a thrombin inhibitor.”

“The Medicines Company’s expertise in advancing the treatment of critical care patients in hospital settings worldwide makes it the natural partner to bring Recothrom to patients and physicians,” said Giovanni Caforio, President, U.S. Pharmaceuticals of Bristol-Myers Squibb. “This agreement is part of Bristol-Myers Squibb’s ongoing efforts to simplify operations, improve our efficiency and better position ourselves to focus on our important work in areas of significant unmet medical need that are critical to our long-term success."

Recothrom net revenues in 2011 were $65 million. The product is currently commercially available in the United States and Canada. The intellectual property license agreement is global and The Medicines Company anticipates pursuing approvals in additional countries.

The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013.

Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an upfront collaboration payment of $105 million and an upfront option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the two-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company’s exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the two-year collaboration term.

The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014.

The transaction is subject to the satisfaction or waiver of closing conditions, including the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the delivery by Bristol-Myers Squibb of certain audited financial information relating to the business.

European Medicines Agency Updates Advice for Spraying Fibrin Sealants During Surgery

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued new instructions to promote safe use of the fibrin sealants Tisseel, Tissucol, Artiss, and Beriplast P during surgery. This advice follows that issued for two other fibrin sealants, Evicel and Quixil, in November 2012. Employed to help reduce local bleeding, these sealants are typically dripped or sprayed onto bleeding tissue to form a fibrin clot.

Reports of gas embolism with Evicel and Quixil in association with the use of spray devices that use a pressure regulator prompted a review of fibrin sealants. These events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in closer-than-recommended proximity to the tissue surface, EMA stated in a press release.

Although EMA reports that risk of gas embolism with Tisseel, Tissucol, and Artiss when applied as spray during surgery was considered to be very low, the Committee concluded that the risk cannot be excluded. It urges that product information for these medicines be updated with new instructions to optimise their safe use. EMA stated the following: 

• The product information should be updated with clear and consistent advice for healthcare professionals regarding recommended pressure and distance to use during spraying application.
• The marketing-authorisation holders for these medicines should ensure that they are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that they contain labels stating the recommended pressure and distance.
• The product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of gas embolism.
• Healthcare professionals in the European Union (EU) will receive a letter outlining the updated information on the safe use of these medicines.

For the fibrin sealant Beriplast P (and associated names), however, the CHMP concluded that "there is no risk associated with this product because it does not require a gas-assisted spray device during application, therefore there is no risk of gas embolism with this product when used in accordance with prescribing advice and with the recommended device."

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.