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ANNOUNCES FDA GRANTS ORPHAN DRUG DESIGNATION FOR CANNABIDIOL IN THE TREATMENT OF AUTOIMMUNE HEPATITIS

 

CBD oil

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for cannabidiol (CBD) in the treatment of autoimmune hepatitis (AIH) to Revive Therapeutics Ltd. (RVV.V)

"We are very pleased to receive orphan drug designation for CBD in the treatment of AIH from the FDA as it allows us to confidently advance our research and development plans our strategic collaboration partner WeedMD Inc.," said Fabio Chianelli, President of Revive. "This milestone builds on Revive's pharmaceutical strategy in developing novel cannabinoid therapies targeting both broad and rare inflammatory and liver diseases and it supports our near-term product and business development strategy in commercializing novel cannabis-based therapies and potential partnering opportunities with licensed producers of cannabis and pharmaceutical companies. We are excited about the long-term potential of plant-derived cannabinoid prescription medicines, which we believe has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEXtrademark (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older."

Under the Orphan Drug Act of 1983, the FDA provides incentives for companies developing treatments that are expected to provide significant therapeutic advantage over existing treatments, and that target rare medical conditions affecting fewer than 200,000 U.S. patients per year. Incentives 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 Autoimmune Hepatitis

AIH is a rare autoimmune disease causing inflammation to the liver, which not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death. The prevalence of AIH is estimated at 75,000 patients in the U.S. The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine. It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934{A –}947). Therefore, given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH.

About Liver Disease

Liver disease is described by irregular functioning of liver, causing disorders like hepatitis, fatty liver (NASH), and cirrhosis. There are over 100 described diseases of the liver affecting at least 30 million people alone in the U.S. A number of factors are driving the liver disease treatment market, which includes rapidly changing lifestyle patterns such as increasing alcohol consumption, unhealthy diets, and increasing prevalence of liver diseases. Liver diseases can result from injury to the liver caused by hepatitis C virus (HCV), hepatitis B virus (HBV), obesity, chronic excessive alcohol use or autoimmune diseases. Major drug categories used in the treatment of liver diseases includes anti-rejection drugs, vaccines, immunosuppressant, chemotherapy drugs and antiviral drugs. According to Allied Market Research, titled, "World Liver Disease Treatment Market {A –} Opportunities and Forecast, 2014 - 2022", the global market for liver disease treatment is projected to reach approximately $19.5 billion by 2022.

About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. (TSX VENTURE:RVV)(OTCQB:RVVTF) is focused on the research, development and commercialization of novel cannabinoid-based therapies. Additional information on Revive is available at www.ReviveThera.com.