Merck (MSD) is taking another step away from a long-standing collaboration with San Francisco-based NGM Biopharmaceuticals, pulling the plug on its option to license an experimental ophthalmology treatment and related compounds.
In an SEC filing, NGM revealed that Merck has verbally notified them that the company will not exercise its option to license experimental anti-complement C3 antibody NGM621 and its related compounds, nor will Merck exercise the related ophthalmology bundle option.
The two companies signed a broad multi-year collaboration to research, discover, develop and commercialize novel biologic therapies back in 2015, with Merck making an upfront payment of $94 million plus purchasing a 15% equity stake in NGM. The collab was amended to reflect a more narrow focus in June 2021.
NGM621 flunked a mid-stage trial back in Oct., failing to reach a primary endpoint in a trial of patients with geographic atrophy — an advanced form of age-related macular degeneration. Following the CATALINA phase 2 proof-of-concept trial results, Merck had a one-time option to a worldwide, exclusive license for NGM621 and its related compounds, either alone or bundled with two additional undisclosed pre-clinical ophthalmology compounds and their related compounds. The drugmaker was required to make its option decision by January 20, 2023.
But Merck seemingly made the call early, returning the full worldwide rights to NGM621 to NGM, who hasn't quite given up on the drug yet. The company presented a post-hoc analyses of the CATALINA trial at the Retina Society meeting last month.
“A closer, post-hoc look at the CATALINA data on a patient-by-patient level suggests that complex, challenging GA lesions coupled with apparent methodology limitations associated with FAF grading may have led to unanticipated variability,” said Charles Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Texas and an investigator for the CATALINA trial. “Post-hoc analyses that attempted to minimize some of this variability have yielded encouraging findings that I believe warrant further evaluation.”
