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Pipeline Overview*

Pipeline Overview

Drug** Planned
Indication
Pre-clinical Phase i/ii Phase iii NDA/Marketed
GI & Inflammation
TALICIA™ (RHB-105) H. pylori infections
Confirmatory Phase III study ongoing
RHB-104 Crohn's disease
Phase III MAP US study & Phase III MAP US2 extension study ongoing
NTM infections
Pivotal Phase III study planned
BEKINDA®
(RHB-102)
Gastroenteritis & gastritis
Successful top-line results from Phase III U.S. study
IBS-D
Phase II U.S. study ongoing
RHB-106 Bowel cleanser
WW rights licensed to Salix Pharmaceuticals
Oncology -
GI/Inflammation
YELIVA® (ABC294640) Multiple indications
Multiple Phase I/II studies ongoing and planned
MESUPRON Pancreatic cancer
Completed Phase II including pancreatic cancer
Other
RIZAPORT®
(RHB-103)
Migraine
U.S. NDA filed - re-submission of NDA planned following CRL
EUROPEAN MAA APPROVED UNDER THE EUROPEAN DECENTRALIZED PROCEDURE
* Estimated timeline/indication in the pipeline is subject to changes in development plans and regulatory requirements/clarifications, including complementary /additional studies ** BEKINDA®, YELIVA®, TALICIA™ and RIZAPORT® are proposed tradenames which are subject to FDA review and approval*** MAA - Marketing Authorization Application;