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.