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Pipeline Overview*

PRODUCT2 Indication Pre-clinical Phase 1/2 Phase 3 Commercial1
Talicia® H. pylori infection3
APPROVED BY U.S. FDA NOVEMBER 2019
Aemcolo® Travelers' Diarrhea4
U.S. EXCLUSIVE LICENSE
Donnatal® IBS and acute enterocolitis5
U.S. CO-PROMOTION
Mytesi® Non-infectious diarrhea in HIV/AIDS patients6
U.S. CO-PROMOTION
EnteraGam® Chronic diarrhea and loose stools7
U.S. EXCLUSIVE LICENSE
Esomeprazole Strontium DR Capsules GERD and other GI conditions6
U.S. COMMERCIALIZATION LICENSE
RHB-104 Crohn's disease
RHB-204 NTM infections
RHB-102
(Bekinda®)
Gastroenteritis & gastritis
IBS-D
RHB-106 Bowel cleanser
ABC294640
(Yeliva®)
Multiple indications
RHB-107 Oncology/GI
Other
RIZAPORT®
(RHB-103)
Migraine
* Estimated timeline/indication in the pipeline is subject to changes in development plans and regulatory requirements/clarifications, including complementary /additional studies ;
1 Aemcolo® planned to be launch in Q4/19; Talicia planned to be launched in Q1/2020
2Bekinda® (RHB-102) and Yeliva® (ABC294640) are proposed tradenames which are subject to FDA review and approval
3Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: here
4 Aemcolo® (Rifamycin) is indicated for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com
5 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome and acute enterocolitis. For full prescribing information see: www.Donnatal.com
6 Mytesi® is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). For full prescribing information see: www.Mytesi.com
7 EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food which must be administered under medical supervision

Company Profile

RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company primarily focused on development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases.

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