RedHill Biopharma Ltd. (Nasdaq: RDHL); TASE: RDHL) has entered into a license agreement with the University of Minnesota to acquire the rights to a patented technology to support the development of a commercial diagnostic test for detection of Mycobacterium avium subspecies paratuberculosis (“MAP”) bacterium. The company’s share price was up 9% on the news.
RedHill’s flagship Crohn’s disease program RHB-104, currently undergoing a first Phase III study in the US, Canada and Israel, is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP infection in susceptible patients. There is currently no validated, commercially available method of detecting the presence or absence of MAP in patients suffering from Crohn’s disease and other diseases.
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As part of its development efforts for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics, a diagnostic test to aid in detecting the presence of MAP in whole blood. The patents acquired from the University of Minnesota are intended to support the ongoing development and validation of this diagnostic test in current and future clinical studies. RedHill will pay the University of Minnesota a one-time upfront payment and an additional potential milestone payment for the licensed technology. A pre-submission meeting with the US Food and Drug Administration (FDA) to discuss the development path for the diagnostic test is scheduled for January 2015.
RedHill chief business officer Guy Goldberg said, “We believe this agreement with the University of Minnesota will strengthen RedHill’s capabilities to develop a diagnostic test to identify MAP bacterium, and is another testament to RedHill’s deep commitment to RHB-104, our potentially groundbreaking Crohn’s disease therapy. Currently, there are no standard tests available to physicians in order to investigate the presence of MAP, which restricts their ability to better understand the potential role of this pathogen in a range of diseases. Together with Quest Diagnostics, we will meet with the FDA in January 2015 to discuss the regulatory path required to gain approval for this product. Should we successfully commercialize a validated, simple to use and precise diagnostic test for MAP, it will provide physicians and researchers with better tools to understand and potentially treat diseases with unknown etiologies, especially autoimmune inflammatory diseases. In addition, if approved for marketing, the diagnostic test holds significant commercial potential.”
Published by Globes [online], Israel business news – www.globes-online.com – on December 18, 2014
Copyright of Globes Publisher Itonut (1983) Ltd. 2014