RedHill resubmits RHB-103 for migraines

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) and partner IntelGenx Corp. (TSX-V:IGX; OTCQX:IGXT) resubmitted an NDA to FDA for RHB-103 to treat acute migraines. The partners received a complete response letter from FDA last month in which they said the agency raised questions related to third-party CMC, packaging and labeling for RHB-103. RedHill has exclusive, worldwide rights to co-develop and commercialize RHB-103 -- a fast-dissolving thin-film formulation of rizatriptan delivered using IntelGenx's VersaFilm oral disintegrating film -- from IntelGenx under a 2010 deal (see BioCentury Extra, Feb. 4). ...