Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), 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 that its INFRADURE™ Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D. INFRADURE is the version of Medgenics’ Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan Drug Designation granted for treatment of a clinical indication using the Biopump.
Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
Marlene Haffner, M.D. MPH, former Director of Orphan Products Development at the FDA, and regulatory advisor to Medgenics said, “I am excited by this grant of Orphan Drug Designation of INFRADURE in hepatitis D. The novel Biopump platform potentially offers significant advance over current treatment not just for an orphan disease, but also for other diseases where protein therapy is a potential treatment. Designated Orphan Products have frequent access for advice to both FDA’s OOPD and to the FDA review divisions. They are also frequently approved by FDA via an accelerated pathway of Priority Review, which is granted for drugs offering a significant advance in the treatment of a serious and life threatening disease, or when there is no approved treatment. The INFRADURE Biopump seems to meet these criteria, particularly since hepatitis D is a serious disease with no approved treatment.”
Bruce R. Bacon, M.D., past President of the American Association for the Study of Liver Disease, a recognized global expert in hepatitis and a member of Medgenics’ Strategic Advisory Board, commented, “INFRADURE offers the potential for a superior treatment for the 15 million people suffering from hepatitis D worldwide. The current treatment for hepatitis D requires years of weekly injections of interferon alpha, which leads to patient discomfort and substantial compliance challenges. Oral antiviral treatments have proven to be ineffective in treating hepatitis D. INFRADURE is intended to be implanted infrequently, with a single administration potentially replacing many months of weekly injections. This could offer a safe and efficacious treatment that could greatly improve patient compliance. The treatment also has potential for efficacy with greater patient compliance for other forms of hepatitis including the 170 million people infected with hepatitis C and the over 350 million people infected with hepatitis B.”