RedHill Biopharma Provides 2017 Year-End Business Update
GlobeNewswire•December 5, 2017
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, today provided a 2017 year-end summary of its main activities and key milestones expected in 2018.
Cost reduction plan. Cash balance1 at the end of 2017 is expected to be approximately $45 million, with no debt. A cost reduction plan is in place to gradually reduce the average quarterly cash burn rate in 2018 to approximately $8.5 million.
Increasing resource optimization and focus on GI, including termination of RIZAPORT® license. Given the Company’s increasing focus on gastrointestinal (GI) diseases and in particular its two key Phase III GI programs with near-term data points and blockbuster potential for Crohn’s disease and H. pylori infection, a notice has been provided to IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT) that RedHill will terminate, effective January 6, 2018, its co-development and commercialization agreement for the non-core migraine drug product candidate, RIZAPORT®, for which a recent Incomplete Response Letter has been received from the FDA.
Top-line results from the ongoing Phase III study with RHB-104 for Crohn’s disease expected mid-2018. Enrollment of all 331 subjects in the MAP US study has been completed and the last patient to reach the primary endpoint assessment (remission at week 26) is expected by May 2018.
Top-line results from the ongoing confirmatory Phase III study with TALICIA™ (RHB-105)2 for H. pylori infection are expected in H2/2018. To date, 136 patients out of a planned total of 444 subjects have been enrolled. TALICIA™ was previously granted QIDP fast track designation from FDA.
A pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections is expected to be initiated in H1/2018, subject to additional input from the FDA. RHB-104 will be assessed as a first-line treatment of pulmonary NTM disease caused by mycobacterium avium complex (MAC) infection, for which QIDP fast-track designation was previously granted by the FDA.
A single-arm Phase IIa study with YELIVA® (ABC294640)3 for the treatment of cholangiocarcinoma (bile duct cancer) is expected to be initiated in the coming weeks at Mayo Clinic and MD Anderson. YELIVA® was granted Orphan Drug designation by the FDA for the treatment of cholangiocarcinoma.
Managed Markets Activity. RedHill is expanding U.S. managed care access and coverage to its commercial products by securing multiple agreements with top managed care organizations.
Dror Ben-Asher, RedHill’s CEO, said: “With a cost reduction and resource optimization plan in place for 2018 and 2019, we are focusing on delivering the two rapidly-approaching Phase III data read-outs with RHB-104 for Crohn’s disease and TALICIA™ for H. pylori infection, which, if approved, have blockbuster potential, given the limitations of available therapies.”
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases and cancer. RedHill promotes three gastrointestinal products in the U.S.: Donnatal® - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg - a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions; and EnteraGam® - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s key clinical-stage development programs include: (i) TALICIA™ (RHB-105) - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis, and a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) YELIVA® (ABC294640) - an orally-administered, first-in-class SK2 selective inhibitor with a planned Phase IIa study for cholangiocarcinoma; (iv) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron with successful top-line results from a Phase III study in acute gastroenteritis and gastritis and successful top-line results from a Phase II study in IBS-D; (v) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and inflammatory gastrointestinal diseases. More information about the Company is available at: www.redhillbio.com.
