Medgenics Ltd. (AIM:MEDG; NYSE: MDGN) has announced that its INFRADURE Biopump for the treatment of Hepatitis D has received orphan drug status from the US Food and Drug Administration (FDA). INFRADURE is the version of Medgenics’ Biopump technology platform, which produces interferon alpha, commonly used to treat hepatitis. Medgenics said that this is the first orphan drug status granted for treatment of a clinical indication using the Biopump.
Orphan drug status brings benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as a faster track regulatory process.
Former FDA director of orphan products development and regulatory advisor to Medgenics Dr. Marlene Haffner 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 and Medgenics’ strategic advisory board member Dr. Bruce R. Bacon said, “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.”
Medgenics president and CEO Dr. Andrew Pearlman said, “The FDA’s timely approval of our Orphan Drug Designation for INFRADURE to treat hepatitis D is a key milestone in our broader hepatitis program as data gathered through clinical trials for INFRADURE in hepatitis D may serve as relevant support for other clinical uses of INFRADURE including hepatitis C and hepatitis B. Following on the FDA’s recent clearance to proceed with our Phase IIb study of the EPODURE™ Biopump technology to treat anemia, and the positive comments of the National Institutes of Health Recombinant DNA Advisory Committee, we see this Orphan Drug Designation from the FDA as another important step in the regulatory pathway for our Biopump platform."
Published by Globes [online], Israel business news - www.globes-online.com - on June 21, 2012
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