TORONTO, Sept. 05, 2018 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (TSX VENTURE: RVV) (OTCQB: RVVTF) (FSE: 31R) ("Revive" or the “Company”), a specialty cannabis company focused on the research, development and commercialization of novel cannabis-based products, is pleased to provide an update on its cannabis-based pharmaceuticals initiatives in its objective in offering novel therapies for unmet medical needs and rare diseases.
“As part of our pharmaceutical strategy, we are focusing our efforts on developing unique cannabis-based therapies for rare diseases,” said Fabio Chianelli, President of Revive. “We are pursuing strategies that we believe will result in lower development costs, faster-time-to-market, and market exclusivity for our cannabis-based pharmaceutical products. We believe by securing patent protection and/or orphan drug status, and establishing proof-of-concept in validated pre-clinical models may expedite the clinical development and regulatory pathway of our products and pave the way for partnering with pharmaceutical companies and licensed producers of medical cannabis.”
Liver Diseases
The Company is advancing its rare liver disease research program to evaluate cannabidiol (“CBD”) in the treatment of autoimmune hepatitis (“AIH”), which is patent-protected and has been granted orphan drug designation by the U.S. Food and Drug Administration (“FDA”). The research program is being overseen by Sanyal Biotechnology LLC. (“SanyalBio”) exploring the use of CBD on a novel AIH model based on the DIAMOND™ model designed and developed by SanyalBio specifically for Revive. The research program is expected to generate a better model of AIH and enable SanyalBio and Revive to further advance the research of cannabinoids for the potential treatment of AIH and other liver diseases such as non-alcoholic fatty liver disease (“NAFLD”), non-alcoholic steatohepatitis (“NASH”), and fibrosis, which may be ideal for pharmaceutical companies and licensed producers of medical cannabis to pursue further development. Results of the AIH research program will be made available this year. There are over 100 described diseases of the liver affecting at least 30 million people alone in the U.S., and the global market for liver disease treatment is projected to reach approximately $19.5 billion by 2022 according to Allied Market Research titled, “World Liver Disease Treatment Market – Opportunities and Forecast, 2014 - 2022”.
Orphan Drug Designations
In addition to the FDA granting Revive orphan drug designation for CBD in the treatment of AIH, the Company recently announced that it has submitted an application to the FDA seeking orphan drug designation of CBD for the treatment of hepatic ischemia and reperfusion injury (“IRI”) during liver transplantation. Revive aims to build a portfolio of FDA orphan drug designations of cannabinoids that are complementary to Revive’s cannabis-based pharmaceuticals initiatives that support the long-term potential of plant-derived cannabinoid prescription medicines for rare diseases and disorders, which the Company believes has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX®.
About Rare Diseases
There are approximately 7,000 different types of rare diseases and approximately 30 million people in the U.S. living with rare diseases. In the U.S., in order for a disease to be consider ‘rare’ it must affect less than 200,000 persons. According to the Kakkis EveryLife Foundation, 95% of rare diseases do not have a FDA approved drug treatment. Since the introduction of the U.S. Orphan Drug Act of 1983, only 326 new drugs were approved by the FDA. To encourage new drug development for rare diseases, the FDA offers incentives to drugs designated with orphan drug status under the Orphan Drug Act of 1983, which include 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 Therapeutics Ltd. (TSX VENTURE: RVV) (OTCQB: RVVTF) (FSE: 31R) is a specialty cannabis company focused on the research, development and commercialization of novel cannabis-based products. Revive is commercializing patent-protected, best-in-class cannabis-based products with first mover advantage in the multi-billion cannabis and wellness market. The Company’s first commercial product is a proprietary hemp-based cannabidiol (“CBD”) chewing gum offering a better alternative over conventional products. The Company’s novel cannabinoid delivery technology is being advanced to fill the unmet medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio currently focuses on rare liver diseases, which the FDA granted to the Company orphan drug designation for CBD in the treatment of autoimmune hepatitis.
For more information visit: www.ReviveThera.com.
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Revive Therapeutics Ltd. Cautionary Note Regarding Forward-Looking Statements
This news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute "forward-looking information" that involves known and unknown risks and uncertainties, which are not comprised of historical facts, and most of which are beyond the control of Revive. Forward-looking statements include estimates and statements that describe Revive’s future plans, objectives or goals, including words to the effect that Revive or its management expects a stated condition or result to occur. Forward-looking statements may be identified by such terms as "believes", "anticipates", "intends", "expects", "estimates", "may", "could", "would", "will", “potential”, or "plan", and similar expressions. Specifically, forward-looking statements in this news release include, without limitation, statements regarding: Revive’s Hemp-based CBD product, Revive’s pharmaceutical cannabinoid strategy and plans; Revive’s cannabinoid delivery technology; Revive’s partnering with pharmaceutical companies and pharmaceutical-like cannabis-based companies; Revive’s liver research with SanyalBio; Revive’s rare disease portfolio and its expansion in rare diseases; Revive’s drug research and development, and commercialization plans; Revive’s branded cannabis-based products; Revive’s Bucillamine program; the timing of operations; and estimates of market conditions. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or events, performance, or achievements of Revive to differ materially from those anticipated or implied in such forward-looking statements. Since forward-looking statements are based on assumptions and address future events and conditions, by their very nature they involve inherent risks and uncertainties. Revive believes that the expectations reflected in these forward-looking statements are reasonable, but there can be no assurance that actual results will meet management's expectations. In formulating the forward-looking statements contained herein, management has assumed: that business and economic conditions affecting Revive will continue substantially in the ordinary course and will be favourable to Revive; that clinical testing results will justify commercialization of the Revive’s product candidates; that Revive will be able to obtain all requisite regulatory approvals to commercialize its product candidates; that such approvals will be received on a timely basis; and, that Revive will be able to find suitable partners for development and commercialization of its product candidates on favourable terms. Although these assumptions were considered reasonable by management at the time of preparation, they may prove to be incorrect and no assurance can be given that such events will occur in the disclosed time frames or at all.
Factors that may cause actual results to differ materially from those anticipated by these forward-looking statements include: uncertainties associated with obtaining regulatory approval to perform clinical trials and market products; the need to establish additional corporate collaborations, distribution or licensing arrangements; Revive’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and biotechnology companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in Revive's Management's Discussion & Analysis for the period ended June 30, 2017 and Revive's other public filings, all of which may be viewed on SEDAR (www.sedar.com). Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.
For more information please contact:
Craig Leon
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (416) 272-5525
Email: craig@revivethera.com