Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of Biopump TM a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced a patent granted by the U.S. Patent and Trademark Office (USPTO) protecting the use of Medgenics’ EPODURE Biopump technology for delivery of erythropoietin (EPO). Medgenics is developing EPODURE to address the need for safer, sustained treatment of anemia. The USPTO also allowed claims covering a similar method for delivery of clotting Factor VIII, underlying Medgenics’ HEMODURE™ Biopump technology for sustained prophylactic treatment of hemophilia. Similar claims covering EPODURE and HEMODURE have also been recently allowed in Japan, China, Korea and Australia. In total, Medgenics’ global portfolio now includes 36 patents issued, with 81 more pending. Medgenics believes its approach to protein therapy has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics’ technologies target the global protein therapy market which is forecast to reach $132 billion in 2013. “As we continue to progress in our clinical trials and move forward in our business development efforts, the protection of our intellectual property becomes critical. We believe that receiving method patents and allowance of key claims for our Biopump™ system for the production and delivery of EPO and Factor VIII proteins increases the value of our intellectual property assets and our company,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. About Medgenics Medgenics is developing and commercializing Biopump™, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in development based on this technology:
- EPODURE™ to produce and deliver erythropoietin from a single administration, which has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for periods of six months to more than 36 months in a Phase I/II dose-ranging trial in Israel and is currently in a Phase IIa trial in dialysis in Israel. An Investigational New Drug application has been cleared by the FDA to initiate a Phase IIb study to evaluate the safety and efficacy of EPODURE in the treatment of anemia in dialysis patients in the U.S.
- INFRADURE™ for sustained production and delivery of interferon-alpha for use in the treatment of hepatitis, which has received approval for two Phase I/II trials in hepatitis C from the Israeli Ministry of Health with the first slated to commence in Q4 2012; and has received Orphan Drug Designation from the FDA for the treatment of hepatitis D.
- HEMODURE™ for sustained production and delivery of clotting Factor VIII therapy for the sustained prophylactic treatment of hemophilia, which is now in development.