Revive Provides Update on its Clinical Development Plan for Cannabidiol in the Treatment of Autoimmune Hepatitis - Seite 2

Revive has an exclusive license from South Carolina Research Foundation for its intellectual property for the use of CBD, either in synthetic or natural form, in the treatment of autoimmune hepatitis (U.S. patent No. 8242178).  Also, the FDA has granted to Revive orphan drug designation for CBD in the treatment of AIH, which provides valuable incentives that could accelerate the approval process, including seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA), and orphan drug grants.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel cannabinoid-based and life sciences products. Revive’s cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation.

For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: [phone]
Email: [e-mail]
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the IND submission to the FDA, including plans to submit the IND within sixty to ninety days,  a proposed Phase 1/2a clinical study, and the aim to initiate a clinical study by the end of Q2-2020.  Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: the risk that the Company may not be able to submit the IND to the FDA; the Company many not obtain approval to proceed with a human clinical study; the inability of the Company to satisfy all conditions to proceed with a human clinical study and the risk of unforeseen delays in the submission of the IND. Reference is also made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.