MIV-802 is a potent, pan-genotypic nucleotide-based inhibitor of the HCV NS5B polymerase, which is currently in preclinical development. Hepatitis C treatment comprises a combination of several pharmaceuticals with different mechanisms. Nucleotides are generally regarded as an important component of any such combination treatment, due to their potent and broad spectrum antiviral effect on multiple HCV genotypes and high barriers to resistance. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors and NS5A inhibitors.
In 2016, Medivir entered into a licensing agreement with Trek Therapeutics for the exclusive rights to develop and commercialize MIV-802 globally, excluding China, Taiwan, Hong Kong and Macau. Under the terms of the agreements, Medivir is entitled to receive milestones based on successful clinical development and royalties capped at a mid-teens -percentage upon commercialization of MIV-802 containing products.
In August 2017, it was announced that Ascletis has licensed the exclusive rights to develop, manufacture and commercialize MIV-802, in Greater China. Under the terms of the agreement, Medivir received an upfront payment, and is entitled to receive milestones based on successful development through commercial launch and tiered royalties on net sales of MIV-802 containing products. Ascletis will fund clinical development, manufacturing and commercialization of MIV-802 in Greater China.