On August 9, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Curon Biopharmaceutical (Curon), a privately held biotechnology company, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases (Press release, Merck & Co, AUG 9, 2024, View Source [SID1234645677]).
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"We continue to identify opportunities to expand and diversify our pipeline," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Early clinical data have provided robust evidence for the potential of CN201 to target and deplete circulating and tissue B cells with the potential to treat a range of malignant and autoimmune diseases."
Under the terms of the agreement, Merck through a subsidiary will acquire full global rights to CN201 for an upfront payment of $700 million in cash. Curon is also eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.
CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, with the potential to induce significant and sustained reductions in B-cell populations. Merck plans to evaluate CN201 as a treatment for B-cell malignancies as well as investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.
"This agreement reflects the drive and dedication of the Curon team," said Zhihong Chen, president and chief executive officer, Curon. "As a pioneer in immuno-oncology, Merck is well positioned to build upon the work done to-date and investigate the wide-ranging, first-in-class potential of CN201."
Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2024 and be accounted for as an asset acquisition. Merck expects to record a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, to be included in non-GAAP results in the quarter that the transaction closes. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results.
Advisors
Hogan Lovells is serving as Merck’s legal advisor in this transaction. Centerview Partners LLC acted as financial advisor to Curon and Goodwin Procter LLP as the company’s legal advisor.
About CN201
CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively.