Merck bags J&J castoff from Hanmi to expand NASH pipeline

Merck
At Merck, HM12525A will slot into a NASH pipeline featuring one other asset, MK-3655 (Merck)

Merck is set to pay Hanmi Pharmaceutical $10 million for the rights to a GLP-1/glucagon dual receptor agonist that Johnson & Johnson discarded last year. J&J studied the drug in midphase obesity clinical trials, but Merck sees it as a potential treatment for nonalcoholic steatohepatitis (NASH).

Hanmi licensed the drug, HM12525A, to J&J in 2015 for $105 million upfront. J&J went on to test the candidate in two phase 2 trials that enrolled severely obese patients, with or without diabetes. The placebo-controlled trials linked the drug, also known as JNJ-64565111 and efinopegdutide, to weight loss, but the overall data package failed to convince J&J to take the program forward.

A little more than one year later, Merck has stepped in to write a new chapter in the story of HM12525A. Merck is paying $10 million up front and committing to milestones of up to $860 million for the near-global rights to the drug. Hanmi retains the rights in its home country of Korea.

Merck’s interest in HM12525A is underpinned by data from the phase 2 trials, which its Sam Engel said in a statement “provided compelling clinical evidence that warrants further evaluation of efinopegdutide for the treatment of NASH.” Engel is associate vice president, clinical research, diabetes and endocrinology at Merck Research Laboratories.

At Merck, HM12525A will slot into a NASH pipeline featuring one other asset, MK-3655. Merck paid NGM Biopharmaceuticals $20 million to exercise its option on the insulin sensitizer at the start of last year. 

At that time, Merck was already talking about putting the drug, also known as NGM313, through a phase 2b trial to assess its effect on liver histology and glucose control in NASH patients with or without diabetes. More than 18 months later, Merck is yet to start the phase 2b. In May, NGM said it expects Merck to start the trial in the second half of 2020. 

Recent changes at the front of the NASH race mean Merck remains within touching distance of the leaders despite the lag between phase 1 and phase 2 development of MK-3655. In recent months, the FDA has rejected Intercept Pharmaceuticals’ obeticholic acid and Genfit has scrapped a phase 3 trial of dual PPARα/δ agonist elafibranor in NASH after failing an interim review.   

For Hanmi, the deal provides a chance to make money from an asset that looked to be on the ropes when J&J dumped it, sending shares in the Korean biotech down 30% in the process. The rejection by J&J followed Eli Lilly’s decision to return the rights to Hanmi’s BTK inhibitor and Boehringer Ingelheim's dumping of cancer drug olmutinib.