TORONTO, ONTARIO–(Marketwired – Sept. 19, 2017) – Revive Therapeutics Ltd. (“Revive” or the “Company”) (TSX VENTURE:RVV)(OTCQB:RVVTF), a company focused on the research, development and commercialization of novel treatments for serious and unmet medical needs, today announced that it has entered into a license agreement with South Carolina Research Foundation (“SCRF”), under which Revive will acquire an exclusive license from SCRF to develop and commercialize a portfolio of patents based on cannabinoid-based therapeutics, such as Cannabidiol, in the treatment of liver diseases.
“The licensing of the patent portfolio of cannabinoids in the treatment of liver diseases is an important milestone for Revive, as we continue to realize our objective of commercializing treatments to address unmet medical needs in liver diseases,” said Craig Leon, Chief Executive Officer of Revive. “We will continue focusing on commercializing our candidates of cannabinoid-based therapies and on expanding our product pipeline in the field of liver disease such as autoimmune hepatitis, liver cirrhosis, non-alcoholic steatohepatitis (NASH), and non-alcoholic fatty liver disease (NAFLD).”
Revive will pay SCRF a nominal one time fee for entering into the license. All other future payments are consistent with industry standard and will be based on clinical trial and revenue milestones reached by Revive in the future.
Note: Janssen has many different combination of drugs in development (along with Achillion) to treat HCV genotypes 1, 2, 4, 5, and 6 that are in phase 2 and phase 2a studies. They are hoping to reduce the treatment duration to 6 to 8 weeks. Alan for www.hcvadvocate.org
While drug developers deserve credit for the enormous progress achieved in hepatology, use of the word ‘cured’ can perhaps be seen as unhelpful given that global statistics paint a very different picture of the impact of viral hepatitis.
It is true that, with highly-effective direct-acting antivirals, the hepatitis C virus (HCV) can be cured within two or three months, but no such cure exists for hepatitis B and the number of deaths caused by both in 2015 was enough for the World Health Organization (WHO) to declare this a major public health problem in need of an urgent response.
Noting that viral hepatitis caused 1.34 million deaths around the world in 2015, a number comparable to those brought about by tuberculosis and higher than the fatalities linked to HIV, the WHO has called for the elimination of this threat by 2030.
Regulus Therapeutics Inc. (RGLS) said the U.S. Food and Drug Administration (FDA) is maintaining a clinical hold on its hepatitis C drug candidate, RG-101. The drug was placed on clinical hold in June 2016, when a second case of jaundice was reported during clinical trials. The FDA update tanked Regulus’ stock price by more than 40% on Monday, when it closed at $1.30 per share, down sharply from Friday’s close of $2.25.
FDA Requests More Data
Although Regulus submitted a response following the clinical hold last summer, the FDA has requested final safety and efficacy data from an ongoing clinical trial. However, Regulus will have to wait until the fourth quarter to present the data, as it won’t be available until after 48 weeks of follow-up have been completed on the drug study.
RG-101 was hailed as a potential hepatitis C blockbuster drug two years ago. The drug works by targeting a particular microRNA in the liver, which aids the replication and translation of the hepatitis C virus in the liver. When used in combination with other therapies, it is believed to shorten the treatment time for hepatitis C