RedHill Biopharma Provides 2017 Year-End Business Update
- 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
- 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 Clinicand MD Anderson. YELIVA® was granted Orphan Drug designation by the FDAfor 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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies
that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates; (v) the Company's ability to successfully market Donnatal® and EnteraGam®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
1 Including cash, short-term investments and non-current bank deposits.
2 TALICIA™ (RHB-105) is an investigational new drug, not available for commercial distribution.
3 YELIVA® (ABC294640) is an investigational new drug, not available for commercial distribution.
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