RedHill Biopharma Receives Notice of Allowance for Two Additional U.S. Patents Covering BEKINDA®

RedHill received Notices of Allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102), expected to be valid until at least 2034, once granted

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications

Top-line results from a Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017

A Phase II study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) is ongoing, with top-line results expected in the third quarter of 2017 

RedHill will host an R&D Day and live webcast on BEKINDA® on Thursday, April 27, 2017 in NYC, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively

RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102)(1). Once granted, the patents are expected to be valid until at least 2034.

Danielle Abramson, Ph.D., RedHill’s Director of Intellectual Property & Research said: "We are very pleased with the allowance of two additional U.S. patents for BEKINDA®. This is an important addition to RedHill’s strong IP portfolio, that will further enhance our protection of BEKINDA®. We are approaching significant milestones with BEKINDA® in the coming months, with top-line results from the Phase III study for gastroenteritis and gastritis expected in the second quarter of 2017 and top-line results from the Phase II for IBS-D expected in the third quarter of 2017."

The patent applications, entitled ‘Antiemetic Extended Release Solid Dosage Forms’ and ‘Ondansetron Extended Release Solid Dosage Forms for Treating Either Nausea, Vomiting or Diarrhea Symptoms’, cover claims directed to ondansetron extended release tablets and methods of treating patients with ondansetron extended release solid dosage forms. In addition to the two new U.S. patent applications, the patent portfolio covering BEKINDA® includes one U.S. patent, two pending U.S. patent applications, 17 foreign patents, and over 35 pending foreign patent applications. 

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications. BEKINDA® is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet.           

Top-line results from the Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017. In February 2017, RedHill announced that the last patient had completed the treatment course and observation period in the randomized, double-blind, placebo-controlled GUARD study, which treated 320 adults and children over the age of 12 in 29 U.S. clinical sites.    

A randomized, double-blind, placebo-controlled Phase II study with BEKINDA® 12 mg is currently ongoing for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 with IBS-D in 16 clinical sites in the U.S. Top-line results are expected in the third quarter of 2017.       

The Phase III GUARD study and Phase II study with BEKINDA® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.