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News Breaks
March 3, 2014
08:15 EDTRDHLRedHill Biopharma, IntelGenx submit response to FDA CRL for VersaFilm product
IntelGenx announced, together with RedHill Biopharma that they submitted a response to the Complete Response Letter of the U.S. Food and Drug Administration for the New Drug Application for their VersaFilm Oral Film Product for the treatment of acute migraines.The companies previously reported on February 4 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL. IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm NDA, and will provide additional updates as and when applicable.
News For RDHL From The Last 14 Days
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July 29, 2015
06:17 EDTRDHLRedHill Biopharma reports Q2 EPS (7c), consensus (46c)
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July 27, 2015
07:12 EDTRDHLRedHill Biopharma provides update on RHB-106 program
RedHill Biopharma (RDHL) provided an update on its RHB-106 tasteless solid oral formulation bowel preparation development program under the worldwide exclusive license agreement with Salix Pharmaceuticals, recently acquired by Valeant Pharmaceuticals International (VRX). Salix confirmed to RedHill that it continues the development of RHB-106. Salix further clarified to RedHill that the bowel purgative product referenced in Valeant's Q2 financial results presentation1 as a failed toxicology screen is not RedHill's RHB-106. On February 27, 2014, RedHill and Salix entered into an exclusive license agreement under which Salix acquired the worldwide exclusive rights to RedHill's RHB-106 encapsulated formulation for bowel preparation and rights to other purgative developments. Financial terms of the transaction included an upfront payment to RedHill of $7M, and an additional $5M in subsequent milestone payments to RedHill. Salix also agreed to pay RedHill tiered royalties on net sales, ranging from low single digits up to low double digits. RHB-106 is an encapsulated formulation intended for the preparation and cleansing of the gastrointestinal tract prior to the performance of abdominal procedures, including diagnostic tests such as colonoscopies, barium enemas or virtual colonoscopies, as well as surgical interventions, such as laparotomies. RHB-106 is a tasteless solid oral dosage potentially allowing an unobstructed procedure with reduced side effects and improved compliance. It is also intended to prevent patient exposure to the often unappealing taste of current products.
July 16, 2015
19:58 EDTRDHLRedHill Biopharma 2.46M share Secondary priced at $16.25
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