Yuhan Co. announced on Jan. 7 that it has licensed out a new nonalcoholic steatohepatitis (NASH) drug candidate to Gilead Sciences, a global pharmaceutical company known for its product Tamiflu, for US$785 million.
Yuhan will receive a down payment of US$15 million (16.7 billion won) from Gilead. Yuhan does not have to return the money even if Gilead gives up development of the technology afterwards. Yuhan will also receive up to US$770 million (858.3 billion won) in milestone payments, which are paid when each milestone in the development and commercialization process is achieved.
This contract is the fifth largest drug technology exports made by Korean pharmaceutical companies. The top four includes Hanmi Pharmaceutical’s Quantum Project (2,824 million Euro), Yuhan's licensing out of Lazertinib (US$1,255 million), and Hanmi’s long-acting obesity diabetes drug and targeted cancer drug (US$915 million and $910 million, respectively).
In particular, this contract is the biggest one ever made in Korea for a pre-clinical stage drug candidate. For Quantum Project and Lazertinib, contracts were made in the course of clinical trials after the candidate substances have been identified.
Yuhan and Gilead will jointly conduct non-clinical studies on the new drug substance, and Gilead will conduct a global clinical trial.
Meanwhile, global market research firm Global Data predicted that the NASH therapeutic market will grow at a CAGR of 45 percent over the next decade from US$618 million in 2016 to US$25.30 billion in 2026.
Currently, four candidates for the NASH drug are in phase III clinical trials, including Gilead’s Selonsertib. However, industry analysts say that Gilead is facing a big problem in Phase III clinical trials as its candidate material has the side effect of severe itchiness. U.S. pharmaceutical company Intercept Pharmaceuticals plans to announce the results of Phase III clinical trials of Ocaliva in the first half of this year.