Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced it has received a Notice of Allowance from the Japanese Patent and Trademark Office for key claims protecting the use of Medgenics’ INFRADURE Biopump™ technology for the delivery of interferon alpha (IFNa). Medgenics is developing INFRADURE™ as a new approach to provide sustained and patient compliant interferon therapy to address unmet needs in the treatment of hepatitis B, C, and D. Similar claims protecting Medgenics’ INFRADURE technology have been granted or allowed in other large Asian markets including, China, Korea and Australia. In addition, these countries have allowed broad claims to Medgenics protecting the core Biopump technology for production and delivery of proteins. Patents covering core Biopump technology for a genetically modified dermal micro-organ have already been granted to Medgenics in the U.S. and in the EU. Medgenics believes its Biopump platform offers an approach to protein therapy with 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. “Securing international protection for our core technology and its various methods of use are critically important as we continue to develop INFRADURE to address major unmet needs in various forms of hepatitis and to move towards commercial development. This allowance of key claims specifically covering the core technology underpinning INFRADURE in some significant hepatitis markets will help to enable us to advance our proprietary technology,” 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.