RedHill Biopharma Provides Update on RHB-106 Program Partnered with Salix Pharmaceuticals

TEL-AVIV, Israel, July 27, 2015 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today provided an update on its RHB-106 tasteless solid oral formulation bowel preparation development program under the worldwide exclusive license agreement with Salix Pharmaceuticals Ltd. ("Salix"), recently acquired by Valeant Pharmaceuticals International, Inc. ("Valeant") (VRX) (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 second quarter 2015 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 $7 million, and an additional $5 million 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.

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (RDHL) (RDHL) is an emerging Israeli biopharmaceutical company primarily focused on the development of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful top-line results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study; (iii) BEKINDA(TM) (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) ABC294640 - an orally-administered first-in-class SK2 selective inhibitor targeting multiple inflammatory-GI diseases and related oncology indications with a first Phase I/II initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (vi)MESUPRON(R) - a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT(TM) (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and (ix)RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.

 

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