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Merck Completes Acquisition of Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical

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Merck (NYSE: MRK) has completed the acquisition of CN201, a novel investigational clinical-stage bispecific antibody, from Curon Biopharmaceutical. CN201 is designed for B-cell depletion therapy with potential applications in B-cell malignancies and autoimmune diseases.

CN201 is currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL). Preliminary data suggest it has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well-tolerated.

Merck has acquired full global rights to CN201. The transaction is being accounted for as an asset acquisition, with Merck recording a pre-tax charge of approximately $750 million, or about $0.28 per share, to be included in third-quarter non-GAAP results.

Merck (NYSE: MRK) ha completato l'acquisizione di CN201, un nuovo anticorpo bispecifico in fase di sviluppo clinico, da Curon Biopharmaceutical. CN201 è progettato per la terapia di deplezione delle cellule B con potenziali applicazioni in tumori delle cellule B e malattie autoimmuni.

Attualmente, CN201 è in fase 1 e fazione 1b/2 di studi clinici per il trattamento del linfoma non-Hodgkin recidivato o refrattario (NHL) e della leucemia linfoblastica acuta a cellule B (ALL). Dati preliminari suggeriscono che ha un’attività nei pazienti con malignità ematologiche a cellule B recidivanti o refrattarie ed è ben tollerato.

Merck ha acquisito i diritti globali completi su CN201. La transazione è contabilizzata come un'acquisizione di beni, con Merck che registra un onere fiscale ante imposte di circa 750 milioni di dollari, ovvero circa 0,28 dollari per azione, da includere nei risultati del terzo trimestre non-GAAP.

Merck (NYSE: MRK) ha completado la adquisición de CN201, un novedoso anticuerpo bispecífico en etapa de investigación clínica, de Curon Biopharmaceutical. CN201 está diseñado para la terapia de depleción de células B con aplicaciones potenciales en tumores de células B y enfermedades autoinmunes.

Actualmente, CN201 se encuentra en ensayos clínicos de Fase 1 y Fase 1b/2 para el tratamiento del linfoma no Hodgkin recaído o refractario (NHL) y de la leucemia linfoblástica aguda de células B (ALL). Los datos preliminares sugieren que tiene actividad en pacientes con malignidades hematológicas de células B recaídas o refractarias y es bien tolerado.

Merck ha adquirido los derechos globales completos sobre CN201. La transacción se está contabilizando como una adquisición de activos, con Merck registrando un cargo previo a impuestos de aproximadamente 750 millones de dólares, o alrededor de 0,28 dólares por acción, que se incluirá en los resultados no GAAP del tercer trimestre.

머크 (NYSE: MRK)는 큐론 바이오제약(Curon Biopharmaceutical)으로부터 신약 실험 중인 이중특이성 항체 CN201의 인수를 완료했습니다. CN201은 B세포 제거 치료를 위해 설계되었으며, B세포 악성종양 및 자가면역 질환에 적용될 수 있는 가능성을 가지고 있습니다.

현재 CN201은 재발성 또는 불응성 비호지킨 림프종(NHL)과 B세포 급성 림프구 백혈병(ALL) 치료를 위한 1상 및 1b/2상 임상 시험을 진행 중입니다. 초기 데이터는 재발성 또는 불응성 B세포 혈액학적 악성종양 환자에서 활성을 보이며, 잘 견딜 수 있다고 제안합니다.

머크는 CN201에 대한 전 세계 모든 권리를 인수했습니다. 이번 거래는 자산 인수로 회계 처리되며, 머크는 약 7억 5천만 달러의 세전 비용, 즉 주당 약 0.28 달러를 기록하여 3분기 비GAAP 결과에 포함될 예정입니다.

Merck (NYSE: MRK) a finalisé l'acquisition de CN201, un nouvel anticorps bispécifique en phase d'essai clinique, auprès de Curon Biopharmaceutical. CN201 est conçu pour la thérapie de déplétion des cellules B avec des applications potentielles dans les malignités des cellules B et les maladies auto-immunes.

Actuellement, CN201 est en essais cliniques de phase 1 et phase 1b/2 pour traiter le lymphome non hodgkinien réfractaire ou récidivant (NHL) et la leucémie lymphoblastique aiguë à cellules B (ALL). Les données préliminaires suggèrent qu'il a une activité chez les patients atteints de malignités hématologiques à cellules B réfractaires ou récidivantes et qu'il est bien toléré.

Merck a acquis les droits mondiaux complets sur CN201. La transaction est comptabilisée comme une acquisition d'actifs, Merck enregistrant un charge préimpôt d'environ 750 millions de dollars, soit environ 0,28 dollar par action, qui sera inclus dans les résultats non-GAAP du troisième trimestre.

Merck (NYSE: MRK) hat die Übernahme von CN201, einem neuartigen, klinisch getesteten bispezifischen Antikörper, von Curon Biopharmaceutical abgeschlossen. CN201 ist für die B-Zell-Depletionstherapie konzipiert und könnte potenzielle Anwendungen in B-Zell-Malignomen und Autoimmunerkrankungen finden.

Aktuell befindet sich CN201 in Phase 1 und Phase 1b/2 klinischen Studien zur Behandlung von rezidiviertem oder refraktärem Non-Hodgkin-Lymphom (NHL) und akuter lymphoblastischer Leukämie vom Typ B (ALL). Vorläufige Daten deuten darauf hin, dass es bei Patienten mit rezidivierenden oder refraktären B-Zell-hämatologischen Malignomen aktiv ist und gut vertragen wird.

Merck hat die vollständigen globalen Rechte an CN201 erworben. Die Transaktion wird als Vermögensübernahme verbucht, wobei Merck einen Vorsteueraufwand von etwa 750 Millionen US-Dollar, also rund 0,28 US-Dollar pro Aktie, verzeichnet, der in die Nicht-GAAP-Ergebnisse des dritten Quartals einfließt.

Positive
  • Acquisition of CN201 broadens Merck's pipeline in B-cell associated diseases
  • CN201 shows potential in both B-cell malignancies and autoimmune diseases
  • Preliminary data suggests CN201 is well-tolerated and effective in relapsed or refractory B-cell hematologic malignancies
  • Merck gains full global rights to CN201
Negative
  • Pre-tax charge of $750 million (approximately $0.28 per share) to be recorded in Q3 non-GAAP results
  • Acquisition cost not included in Merck's full-year financial outlook issued on July 30

Insights

The acquisition of CN201 by Merck is a strategic move to expand its pipeline in B-cell targeted therapies. This bispecific antibody has dual potential in oncology and autoimmune diseases, which aligns with Merck's focus on innovative treatments. The ongoing Phase 1 and Phase 1b/2 trials for NHL and ALL, respectively, indicate promising early-stage development.

Preliminary data suggesting activity in relapsed/refractory B-cell malignancies with good tolerability is encouraging. If successful, CN201 could address significant unmet needs in these difficult-to-treat patient populations. The $750 million upfront investment reflects Merck's confidence in the asset's potential, although it will impact short-term financials with a $0.28 per share charge in Q3.

Investors should monitor upcoming trial results and potential expansion into autoimmune indications. The acquisition could bolster Merck's long-term growth prospects in hematology-oncology and immunology, but near-term impact on revenue is likely given the early stage of development.

Merck's $750 million acquisition of CN201 represents a significant investment in expanding its pipeline. This charge, equating to $0.28 per share, will impact Q3 non-GAAP results but wasn't factored into the previous full-year outlook. Investors should anticipate a potential adjustment to the annual guidance when Merck reports Q3 results on October 31.

The transaction, structured as an asset acquisition, allows Merck to gain full global rights to CN201. This approach can be financially advantageous compared to a full company acquisition, potentially offering tax benefits and lower integration costs. However, it also means taking on the full development risk of the asset.

While the short-term financial impact is notable, the long-term value proposition hinges on CN201's clinical success and market potential across multiple indications. Investors should weigh this pipeline enhancement against the immediate earnings impact and consider it in the context of Merck's overall R&D strategy and portfolio diversification efforts.

Addition of CN201, a next generation CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, broadens and fortifies Merck’s pipeline

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases.

“By actively depleting B-cells, CN201 offers applications spanning both B-cell malignancies and autoimmune diseases. We look forward to building upon the foundational work started by the Curon team,” said Dr. Dean Y. Li, president, Merck Research Laboratories.

CN201 is currently being investigated 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, potentially leading to significant and sustained reductions in B-cell populations.

Transaction details

Under the agreement, Merck, through a subsidiary, has acquired full global rights to CN201. As previously disclosed, the transaction is being accounted for as an asset acquisition. Merck is recording a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, which will be included in third-quarter non-GAAP results and was not included in Merck’s full-year financial outlook issued on July 30. 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 on October 31.

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.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:



Robert Josephson

(203) 914-2372



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Investor Contacts:



Peter Dannenbaum

(732) 594-1579



Damini Chokshi

(732) 594-1577

Source: Merck & Co., Inc.

FAQ

What is CN201 and what did Merck (MRK) acquire it for?

CN201 is a novel investigational clinical-stage bispecific antibody for B-cell depletion therapy. Merck acquired it from Curon Biopharmaceutical to expand its pipeline in B-cell associated diseases, including B-cell malignancies and autoimmune diseases.

What clinical trials is CN201 currently undergoing for Merck (MRK)?

CN201 is currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL), respectively.

How much did Merck (MRK) pay for the acquisition of CN201?

Merck is recording a pre-tax charge of approximately $750 million, or about $0.28 per share, for the acquisition of CN201. This includes the upfront payment and other related costs.

When will Merck (MRK) update its full-year financial outlook following this acquisition?

Merck will provide an update to its full-year financial outlook when it reports third-quarter 2024 results on October 31.

Merck & Co., Inc.

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