Adam Lenkowsky, chief commercial officer for Bristol Myers Squibb Co. (BMS), said his firm plans to launch Karxt (xanomeline-trospium) in the U.S. as soon as it’s approved by the U.S. FDA, and “expect[s] to accumulate sales in early 2025.” BMS tied a bow on the year by disclosing its plan to pay $330 per share to take over Karuna Therapeutics Inc. in a deal valued at $14 billion to bring aboard Karxt, which acts as a dual M1/M4 muscarinic acetylcholine receptor agonist. The FDA has assigned Sept. 26, 2024, as the PDUFA date for Karxt as a new treatment for schizophrenia in adults.
A threat to biopharma innovation arrived at a larger scale in 2023 in the form of greater U.S. FTC scrutiny, calling into question the legitimacy of certain M&As and deals.
The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. The newest of the deals were focused on Asia. GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Also, South Korea’s Dong-A ST Co. Ltd. is expanding into the ADC space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development.
Compugen Ltd. has entered another collaboration, this time exclusively licensing a preclinical antibody program against an IL-18 binding protein with Gilead Sciences Inc. Compugen will handle ongoing preclinical development and a phase I study of COM-503 to treat tumors, then Gilead receives to sole right to further continue developing the asset. Compugen is getting an up-front $60 million and is eligible for a $30 million milestone payment should the IND clear in 2024. Compugen also is eligible for $758 million in development, regulatory and commercial milestones, putting the deal value at $848 million.
October marked a milestone in biopharma history, with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s $22 billion deal the largest in BioWorld’s records going back to 2014. Tokyo-based Daiichi is granting rights to three of its DXd antibody-drug conjugate candidates for the treatment of multiple solid tumors: ifinatamab deruxtecan, patritumab deruxtecan and raludotatug deruxtecan. The companies will co-develop and co-commercialize the three candidates worldwide, excluding Japan, where Daiichi retains exclusive rights.
Biopharma deals totaled $18.97 billion in November, marking a notable decrease from October’s historic deal value of $44.91 billion. Even still, through the first 11 months of 2023 cumulative deal value reached $194.26 billion, an 18.65% gain over the $163.73 billion recorded in the same period in 2022.
Pfizer Inc. proved its ongoing interest in antibody-drug conjugates (ADCs), as well as at least tentative faith in mesothelin as a target, by snatching up Nona Biosciences Inc. for up to $53 million in up-front and near-term cash along with possibly $1.05 billion in milestone payments as the drug advances.
Astrazeneca plc, which seemed to have backed away from vaccine development after the COVID-19 pandemic, clearly took a shine to Icosavax Inc.’s virus-like particle technology and signed a deal to take over the firm for as much as $1.1 billion.
Sanofi SA backed out of its $750 million effort to advance Maze Therapeutics Inc.’s oral Pompe disease candidate, MZE-001, after the U.S. FTC filed a federal lawsuit to block the deal, claiming the Paris-based firm was seeking to eliminate a nascent competitor.
Degrader-antibody conjugates (DACs) are at the heart of the new deal between C4 Therapeutics Inc. and Merck & Co. Inc. C4 will get $10 million up front, milestones that could total $600 million and about $2.5 billion across the entire collaboration.
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