RedHill Biopharma Provides Business Update
“Our primary objective during this global pandemic is to safeguard the health of our employees, healthcare workers, families and communities while minimizing the impact on our commercial and R&D operations,” said
We have implemented a remote working policy for all of RedHill’s employees, including our field sales force, to support the global containment efforts. We are employing virtual tools to support our employees and provide patients and physicians with information to ensure continued access to our commercial products, Talicia® and Aemcolo®. We continue with non-personal promotional initiatives and remote training, as well as planning for the promotion for Movantik® (subject to closing of the acquisition from AstraZeneca).
We continue to pursue our R&D plans subject to the relevant temporary constraints and limitations related to the COVID-19 virus outbreak. The initiation of the pivotal Phase 3 study evaluating RHB-204 as a first-line, stand-alone treatment for pulmonary nontuberculous mycobacteria (NTM) infections caused by Mycobacterium avium complex (MAC) is planned to be deferred by one quarter, to the third quarter of 2020. We continue to make progress with our previously announced development program with opaganib (Yeliva®, ABC294640), individually and in combination with other compounds, for the treatment of COVID-19 and expect to provide more detailed updates in the near future.
We will continue to monitor and act on the implications of the COVID-19 virus outbreak and provide updates.
About RedHill Biopharma
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 related to the effects of the global COVID-19 virus outbreak, including effects on our supply chain and on our development efforts, as well as 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, and the timing of the commercial launch of its therapeutic candidates and its FDA-approved products; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (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 and Talicia®; (v) the Company’s ability to successfully commercialize and promote Talicia® and Aemcolo® and following closing of the acquisition, Movantik®; (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 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin, and rifabutin) is available at: www.Talicia.com.
2 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
3 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
Adi Frish Senior VP Business Development & Licensing RedHill Biopharma+972-54-6543-112 email@example.com IR contact ( U.S.): Timothy McCarthy, CFA, MBA Managing Director, Relationship Manager LifeSci Advisors, LLC+1-212-915-2564 firstname.lastname@example.org
Source: RedHill Biopharma Ltd.