Novartis has entered into a potential $1.305 billion agreement to license a rare disease candidate from Chong Kun Dang Pharmaceutical — the biggest ever out-licensing deal for the South Korean company.
Under the agreement, Novartis obtains exclusive rights outside of South Korea for the development and commercialization of CKD-510, a low-molecular compound histone deacetylase 6 (HDAC6) inhibitor that is being developed for Charcot-Marie-Tooth disease (CMT) treatment.
CMT is a rare hereditary disorder that affects the nerves supplying the feet, legs, hands and arms. While not fatal, the disease currently has no cure. To that end, CKD-510 received Orphan Drug designation from the FDA in March 2020. While the phase 1 drug was originally developed as a treatment for CMT disease, preclinical studies have also demonstrated its efficacy in various HDAC6-related diseases, including cardiovascular conditions.
Per the deal, Novartis will pay Chong Kun Dang $80 million upfront, as well as milestone payments up to $1.225 billion, dependent on development and regulatory approvals.
Novartis has tangled with HDAC inhibitors in the past. Back in 2015, the drugmaker won accelerated approval for Farydak, the first HDAC inhibitor for patients with multiple myeloma. Saddled with a black box warning and facing treatment competition, market uptake for Farydak wasn't as expected, and Novartis ended up offloading the drug to Secura Bio in 2019. Unable to complete the post-marketing studies that were necessary for full approval, Secura ended up withdrawing the treatment's NDA in 2021.
