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February 4, 2014
08:13 EDTIGXT, RDHLRedHill Biopharma, IntelGenx receive complete response letter from FDA
RedHill Biopharma (RDHL) together with IntelGenx (IGXT) announced that they received a Complete Response Letter, or CRL from the FDA regarding the New Drug Application for RHB-103 for the treatment of acute migraines. RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies. While continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks. RedHill and IntelGenx have been in active discussions with potential partners for the commercialization of RHB-103 and expect to advance these discussions rapidly following FDA's CRL which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding RHB-103's safety.
News For RDHL;IGXT From The Last 14 Days
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December 18, 2014
06:18 EDTRDHLRedHill Biopharma acquires techonology from University of Minnesota
RedHill Biopharma (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 bacterium. RedHill's Crohn's disease program RHB-104, currently undergoing a first Phase III study, is based on evidence that Crohn's disease is caused by MAP infection in susceptible patients. As part of development for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics (DGX), a diagnostic test to aid in detecting the presence of MAP in whole blood. 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 FDA to discuss the development path for the diagnostic test is scheduled for January 2015.
December 17, 2014
06:14 EDTRDHLRedHill Biopharma enrolls first patients in Phase III study of RHB-102
Red Hill announced that the randomized, double-blind, placebo-controlled Phase III study with RHB-102 for acute gastroenteritis and gastritis is underway in the U.S., with a planned enrollment of 320 patients. Top-line results from the Phase III GUARD study are expected during 2H15. RedHill recently submitted a European Marketing Authorization Application seeking approval of RHB-102 for cancer patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting. Results are intended to support potential future submissions of marketing applications in both the U.S. and Europe for this indication. In parallel, RedHill is pursuing marketing approval for RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting in Europe and the U.S.

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