RAHWAY, N.J., Jan. 2, 2025 – President Jimmy Carter exemplified a life of service, through his governorship and presidency, and later through The Carter Center and its commitment to improving the health and well-being of those most in need. We are privileged to have worked side-by-side with President Carter and the Center on its ongoing work to eliminate river blindness in countries throughout Africa and Latin America. Over decades of partnership through our Mectizan® Donation Program, the Center has distributed more than 500 million treatments and profoundly impacted the lives of millions of people in these countries. While President Carter did not want credit for the program, all of us at MSD know it was his leadership and commitment to global health that made this a reality.
We share in the grief of all those whose lives have been touched by President Carter. They are a living testament to his compassion, selflessness and generosity. Together, we will continue the Center’s mission with the memory of President Carter as our guide. May he rest in the peace he wished for the world.
RAHWAY, N.J., December 20, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) today announced the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd. As previously announced, MSD will develop, manufacture and commercialize LM-299.
MSD will record a pre-tax charge relating to the upfront payment of $588 million, or approximately $0.18 per share, in the company’s fourth quarter 2024 GAAP and non-GAAP results. LaNova is also eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications, including $300 million upon technology transfer anticipated to be completed in 2025.
About LM-299
LM-299 is an investigational bispecific antibody targeting both programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This innovative therapeutic approach is designed to inhibit both PD-1/PD-L1 and VEGF/VEGFR receptor signaling pathways releasing a key immune checkpoint while also inhibiting the production of new blood vessels (angiogenesis). LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase 1 clinical trial for LM-299 is currently enrolling patients in China.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
RAHWAY, N.J., December 18, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.
“We continue to leverage science-driven business development to augment and complement our robust pipeline,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “Through this agreement, we aim to build on our experience targeting incretin biology to evaluate HS-10535 and its potential to provide additional cardiometabolic benefits beyond weight reduction.”
Under the agreement, Hansoh Pharma has granted MSD an exclusive global license to develop, manufacture and commercialize HS-10535. Hansoh Pharma will receive an upfront payment of $112 million and is eligible to receive up to $1.9 billion in milestone payments associated with the development, regulatory approval and commercialization of the candidate, as well as royalties on sales. Hansoh Pharma may co-promote or solely commercialize HS-10535 in China subject to certain conditions. MSD will record a pre-tax charge of $112 million, or $0.04 per share, to be included in GAAP and non-GAAP results in the fourth quarter of 2024.
“We are pleased to announce the in-license of our oral GLP-1 by MSD, a company with established leadership in cardiometabolic diseases,” said Ms. Eliza Sun, Executive Director of the Board, Hansoh Pharma. “Hansoh Pharma is becoming an emerging leader in metabolic diseases, and we see MSD’s expertise and capabilities as key to accelerating the development of this promising asset for patients worldwide.”
About Hansoh Pharma
Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
RAHWAY, N.J., November 14, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology company, today announced that MSD has entered into an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova.
“At MSD, we continue to assemble a strong and diversified oncology pipeline spanning differentiated mechanisms and multiple modalities,” said Dr. Dean Y. Li, president, MSD Research Laboratories. “This agreement adds to MSD’s growing oncology pipeline and we look forward to advancing LM-299 with speed and rigor for patients in need.”
Under the agreement, LaNova has granted MSD an exclusive global license to develop, manufacture and commercialize LM-299. LaNova will receive an upfront payment of $588 million. LaNova is also eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications.
“This agreement with MSD is a strong testament to the hard work of LaNova’s talented team of scientists who created LM-299,” said Dr. Crystal Qin, founder, chairwoman and chief executive officer, LaNova. “Through internal R&D innovation and strategic external partnerships, LaNova is committed to advancing its pipeline to benefit patients worldwide.”
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 fourth quarter of 2024. MSD expects to record a pre-tax charge relating to the $588 million payment due upon closing to be included in GAAP and non-GAAP results in the quarter that the transaction closes, and the EPS impact of such charge will be disclosed at that time.
About LM-299
LM-299 is an investigational bispecific antibody targeting both programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This innovative therapeutic approach is designed to inhibit both PD-1/PD-L1 and VEGF/VEGFR receptor signaling pathways releasing a key immune checkpoint while also inhibiting the production of new blood vessels (angiogenesis). LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase 1 clinical trial for LM-299 is currently enrolling patients in China.
About LaNova Medicines Ltd.
Founded in September 2019, LaNova Medicines Ltd. is a privately held biotech company headquartered in Shanghai. With the mission of “Care for life, Dedicate to innovation”, the Company focuses on discovering novel biologic therapies in the fields of ADC and Immuno-Oncology, with a commitment to developing best-in-class or first-in-class therapies that address significant unmet medical needs.
LaNova’s robust portfolio is made possible by an industry-leading R&D engine, which includes three distinct platforms: a proprietary antibody platform capable of generating antibodies against a range of targets, including multi-transmembrane proteins and GPCRs; a next-generation ADC platform that utilizes proprietary payload and linker technologies to produce highly differentiated ADCs; and a modular 4-1BB-based T-cell engager (TCE) platform for developing bispecific antibodies targeting distinct tumor-associated antigens (TAAs).
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
In the Phase 2b/3 trial, clesrovimab reduced RSV-associated hospitalizations (secondary endpoint) and RSV-associated lower respiratory infection hospitalizations (tertiary endpoint) by more than 84% and 90%, respectively, through 5 months
Clesrovimab has the potential to become the first and only approved immunization designed to protect infants with the same single dose regardless of weight for the duration of their first RSV season
RAHWAY, N.J., Oct. 17, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today announced the presentation of positive results from the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab, the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, along with interim findings from the ongoing Phase 3 trial (MK-1654-007) of clesrovimab, were presented during IDWeek 2024, held October 16-19 in Los Angeles, California.
Results from MK-1654-004, a placebo-controlled Phase 2b/3 pivotal trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age) met all prespecified endpoints, with consistent results through both the 5-month and 6-month time points. The incidence of adverse events (AEs) and serious AEs were comparable between the clesrovimab and placebo groups, and there were no treatment or RSV-related deaths during the study.
“RSV continues to be a widespread seasonal infection that can affect both healthy and at-risk infants and is the leading cause of hospitalization for infants,” said Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude’s Children’s Research Hospital and investigator for the MK-1654-004 and MK-1654-007 trials. “The MK-1654-004 study evaluated a broad spectrum of RSV disease ranging from mild outpatient illness to severe disease requiring hospitalization. These promising results demonstrating decreased incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in helping to alleviate the continued burden of RSV on infants and their families.”
The primary efficacy endpoint of the trial, the reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥ 1 indicator of lower respiratory infection (LRI) or severity compared to placebo through Day 150 (5 months) postdose, was 60.4% (95% CI: 44.1, 71.9, p<0.001). Clesrovimab also reduced RSV-associated hospitalizations (secondary endpoint) and RSV-associated LRI hospitalizations (tertiary endpoint) through Day 150 (5 months) compared to placebo by 84.2% (95% CI: 66.6, 92.6, p<0.001) and 90.9% (95% CI: 76.2, 96.5), respectively. Clesrovimab reduced the incidence of severe MALRI (tertiary endpoint) by 91.7% (95% CI: 62.9, 98.1).
In addition, in a post hoc analysis, the reduction in incidence of MALRI requiring ≥ 2 indicators of LRI and severity (an endpoint of more severe MALRI than the primary MALRI endpoint), was 88.0% (95% CI: 76.1, 94.0) through Day 150 (5 months).
Additional details on the data from the MK-1654-004 trial across RSV disease burden are presented in order of decreasing disease severity endpoints in the tables below.
a. Full Analysis Set Population.
b. LRI Hospitalization defined as: RSV PCR positive AND hospital admission for respiratory illness AND cough or difficulty breathing AND at least 1 of the following: wheezing, chest wall indrawing/retractions, rales/crackles, hypoxemia, tachypnea, dehydration due to respiratory symptoms.
c. RSV-associated Hospitalization defined as: RSV PCR positive AND hospital admission for respiratory illness.
d. Secondary endpoint, p<0.001 (criterion=lower bound of the 95% CI >0%).
e. Primary endpoint, p<0.001 (criterion=lower bound of the 95% CI >25%).
MSD also announced data from a planned interim analysis of the MK-1654-007 trial, a Phase 3 trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease. The primary endpoint of the study is the safety and tolerability of clesrovimab in infants entering their first RSV season. Interim results showed clesrovimab had a comparable safety profile to palivizumab, and no drug-related serious AEs were reported to date. Incidence rates of RSV-associated MALRI requiring ≥ 1 indicator of LRI or severity and RSV-associated hospitalizations (secondary endpoints) were also comparable between clesrovimab (3.6% and 1.3%, respectively) and palivizumab (3.0% and 1.5%, respectively) through Day 150 (5 months).
“The breadth of data presented at IDWeek highlight the potential for clesrovimab to help lessen the significant impact RSV can have on infants and their families, as well as the strain on healthcare systems due to high infection and hospitalization rates,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, MSD Research Laboratories. “These clinically meaningful findings also reinforce the potential for clesrovimab to be the first and only immunization designed to protect both healthy and at-risk infants using the same dose, regardless of weight. We look forward to continuing to discuss these data with health authorities around the world with the goal of making clesrovimab available for infants as early as the 2025-26 RSV season.”
About MK-1654-004
MK-1654-004 (NCT04767373) is a Phase 2b/3 double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of clesrovimab in healthy preterm and full-term infants from birth to 1 year of age entering their first RSV season. The study enrolled 3,632 participants who were randomized 2:1 to receive either a single fixed dose of clesrovimab (105 mg intramuscular injection (IM)) or placebo on Day 1. Primary endpoints included the incidence of participants with RSV-associated medically attended lower respiratory infection (MALRI) from Day 1 (postdose) to Day 150 as compared to placebo and safety. The MALRI definition required >1 indicator of LRI or severity. RSV-associated hospitalization through Day 150 and MALRI requiring >1 indicator of LRI or severity to Day 180, were prespecified secondary endpoints. Prespecified tertiary endpoints included acute respiratory infection, RSV-associated lower respiratory infection hospitalizations and incidence of severe MALRI through Day 150. In a post hoc analysis, more severe forms of RSV-associated MALRI (>2 indicators of LRI and severity) were assessed. Across endpoints, additional measures of efficacy were assessed through Day 180. Safety measures included the percentage of participants with solicited injection-related adverse events (AEs), AEs of special interest (AESIs) solicited systemic AEs or serious adverse events (SAEs).
About MK-1654-007
MK-1654-007 (NCT04938830) is a Phase 3, multicenter, randomized, partially blinded, controlled study to evaluate the safety, efficacy, and pharmacokinetics of clesrovimab in infants and children at increased risk for severe RSV disease compared to palivizumab. The study enrolled participants who were entering their first RSV season and recommended to receive palivizumab due to prematurity (≤35 weeks gestational age), chronic lung disease (CLD) of prematurity, or hemodynamically significant congenital heart disease (CHD). Participants were randomized 1:1 to receive clesrovimab (105 mg IM on Day 1, placebo on Day 28) or monthly palivizumab in their first season, and eligible participants received clesrovimab (210 mg IM) in the second RSV season. At this interim analysis, 901 participants were enrolled in the trial. The primary endpoint is safety and tolerability of clesrovimab versus palivizumab in the first season. Secondary endpoints include the incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥1 indicator of LRI or severity and of RSV-associated hospitalization through Day 150.
About clesrovimab (MK-1654)
Clesrovimab (MK-1654) is an investigational, extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV. Clesrovimab is designed to be administered as the same single dose, regardless of birth weight, and is being studied in healthy preterm, full-term and at-risk infants to provide direct, rapid, and durable protection through their first RSV season against mild, moderate and severe RSV.
AboutRSV
Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infections like the flu, with a worldwide burden in infants and older adults. There is high unmet need for preventative options in both healthy and high-risk infants. Globally, RSV is the leading cause of hospitalization for healthy infants under a year old. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under five. According to the CDC, RSV season starts in the fall and peaks in the winter in most regions of the United States, but timing and severity in a given community or region can vary year to year.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
Addition of CN201, a next generation CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, broadens and fortifies MSD’s pipeline
RAHWAY, N.J., Oct. 1, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) 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, MSD 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, MSD, through a subsidiary, has acquired full global rights to CN201. As previously disclosed, the transaction is being accounted for as an asset acquisition. MSD 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 MSD’s full-year financial outlook issued on July 30. As a matter of policy, MSD 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 MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
Tulisokibart is now being evaluated in two Phase 3 studies in ulcerative colitis and Crohn’s disease
12-week data from the Phase 2 ARTEMIS-UC trial recently published in the New England Journal of Medicine
RAHWAY, N.J., Sept. 26, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) today announced that new data highlighting the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in ulcerative colitis (UC) and Crohn’s disease (CD) will be presented at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria.
Long-term efficacy and safety data for tulisokibart from the open-label extension period of the Phase 2 ARTEMIS-UC and APOLLO-CD studies will be featured in two oral presentations. In both studies, at week 50, maintenance of treatment efficacy was generally observed in 12-week induction responders. The observed safety profile in the study extensions was consistent with previously reported data. Key data presentation details:
#OP078: Long-term efficacy and safety of tulisokibart in patients with Crohn’s disease (CD): Results from the open-label extension period of the Phase 2 APOLLO-CD study; October 14, 10:12-10:24 a.m. CEST
#OP194: Long-term efficacy and safety of tulisokibart in patients with ulcerative colitis (UC): Results from the open-label extension period of the Phase 2 ARTEMIS-UC study; October 15, 11:54-12:06 p.m. CEST
“We are encouraged by the new maintenance data for tulisokibart in ulcerative colitis and Crohn’s disease, which shows the potential of this novel approach to help patients achieve long-term clinical remission,” said Dr. Aileen Pangan, vice president, global clinical development, MSD Research Laboratories. “Many patients with inflammatory bowel disease do not achieve their treatment goals despite available therapies. There is still a need for additional treatment options to enable patients to manage the challenging symptoms of ulcerative colitis and Crohn’s disease.”
MSD has initiated two Phase 3 studies to evaluate the efficacy and safety of tulisokibart in patients with UC (ATLAS-UC; NCT06052059) and CD (ARES-CD; NCT06430801). These are the first Phase 3 clinical studies for an anti-TL1A antibody in inflammatory bowel disease.
Additionally, results from ARTEMIS-UC, a Phase 2 proof-of-concept study evaluating the efficacy and safety of tulisokibart in patients with moderately to severely active UC were recently published in the New England Journal of Medicine. These data were first presented at the 18th Congress of European Crohn’s and Colitis Organisation (ECCO) in 2023. Findings published in the New England Journal of Medicine show that after 12 weeks, tulisokibart was more effective than placebo for inducing clinical remission in patients with moderately to severely active UC. The publication also includes additional data from a prespecified analysis of patients with a positive test for likelihood of response from cohorts 1 and 2.
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of the large intestine that causes chronic inflammation and ulcers in the lining of the large intestine and rectum. Symptoms of UC include diarrhea, rectal bleeding, abdominal pain, rectal urgency and weight loss, with some patients also developing complications such as strictures. The severity of symptoms places a substantial burden on the more than five million people living with UC worldwide.
About Crohn’s Disease
Crohn’s disease (CD) causes chronic inflammation which can affect all parts of the gastrointestinal tract from mouth to anus. Symptoms of CD include abdominal pain, diarrhea with or without bleeding and weight loss. These symptoms, along with complications such as fistulas and strictures, can cause significant physical burden on the estimated six to eight million people living with CD worldwide.
About Tulisokibart
Tulisokibart is an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), that is associated with both intestinal inflammation and fibrosis. Tulisokibart is thought to bind both soluble and membrane-bound human TL1A. Clinical studies suggest that tulisokibart may inhibit inflammatory pathways involved in inflammatory bowel disease (IBD), and help reduce intestinal fibrosis, which may be important in altering disease progression in IBD. MSD is developing tulisokibart for the treatment of immune-mediated inflammatory diseases including ulcerative colitis, Crohn’s disease and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
RAHWAY, N.J., September 4, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) and EyeBio, a wholly-owned subsidiary of Merck & Co., Inc., Rahway, N.J., USA, today announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).
MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. The initiation of the BRUNELLO trial is based on results from the open-label, Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).
“Data from the Phase 1/2 AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease,” said Dr. David Guyer, founder, chief executive officer and president of EyeBio. “The initiation of the BRUNELLO trial marks an important milestone as we work with our new colleagues at MSD, driven by the common purpose to deliver new, much needed options for patients with diabetic macular edema.”
About the BRUNELLO trial
BRUNELLO is a randomized, double masked Phase 2b/3 trial (NCT06571045) evaluating the efficacy and safety of two dose levels of intravitreal (IVT) Restoret (MK-3000) versus active control ranibizumab in patients with DME. Eligible patients will be randomized 1:1:1 to receive low and high dose regimens of MK-3000 or ranibizumab every four weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. The dual primary endpoints are safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision. For further information about the BRUNELLO trial, please visit www.clinicaltrials.gov.
About diabetic macular edema
Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality of life if left untreated. DME impacts an estimated 750,000 people in the United States and occurs when damaged blood vessels leak into the retina, resulting in swelling in the macula, the central region of the retina crucial for precise vision necessary for everyday activities. The prevalence of DME is anticipated to rise with the increasing incidence of diabetes.
About Restoret
Restoret (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). MK-3000 is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
Reached more than 550 million people with its medicines and vaccines through commercial channels, clinical trials, voluntary licensing and product donations in 2023
Committed to be net-zero across Scopes 1, 2 and 3 greenhouse gas emissions by 2045, aligned with guidance from the Science Based Targets initiative
Sourced 57% of its purchased electricity from renewable sources in 2023
Achieved greater than 99% parity in compensation between female and male employees, indicated via its 2023 global pay equity study of more than 65,000 employees
Through 2023, the company has reached more than 30 million women through MSD for Mothers
MSD increased its spend with small and diverse Tier 1 and 2 suppliers globally from $3.2 billion in 2022 to $3.6 billion in 2023
RAHWAY, N.J., August 19, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) has published its 2023/2024 Impact Report, demonstrating strong progress in sustainability and reaffirming its commitment to enabling broad, equitable access to its medicines and vaccines.
“Expanding and enabling equitable access to our medicines and vaccines for the hundreds of millions of people around the world who depend on us is both a great responsibility and a profound privilege,” said Robert M. Davis, chairman and chief executive officer, MSD. “Driven by an unwavering sense of urgency and fueled by a relentless focus on leading-edge science, we will continue to deliver innovative solutions that address some of the world’s most serious global health challenges and deliver societal value.”
MSD continues to demonstrate an enduring dedication to advancing global health and extending access to solutions that address critical medical needs. In 2023, the company invested $30.5 billion in research and development (R&D), including expenditures related to certain business development transactions. The company is addressing 83% of the top 20 global burdens of disease through its pipeline and products.
Notable highlights across the company’s four sustainability focus areas include:
Access to Health
In 2023, MSD reached more than 550 million people with its medicines and vaccines through commercial channels, clinical trials, voluntary licensing and product donations.
The company reached approximately 385 million people through its MECTIZAN® Donation Program (MDP), the longest-running disease-specific drug donation program of its kind. MDP significantly contributes to the global effort to help eliminate river blindness and lymphatic filariasis.
In 2023, MSD also enabled access to its innovative medicines and vaccines for 240 million people, making considerable progress toward its goal of enabling access for 350 million more people by 2025.
Additionally, in 2023, MSD reached nearly 80% of countries globally with its products, surpassing its annual goal of reaching at least 75% of countries for the third consecutive year.
Between 2021 – 2023, through social investments to improve health equity, MSD reached more than 54 million people in low- and middle-income countries and populations underserved by health care in high-income countries, including 21 million people last year alone.
The company has now surpassed its 2025 goal of reaching 50 million people with its social investments.
Through 2023, the company has reached more than 30 million women through MSD for Mothers.
Employees
Women now comprise 51% of MSD’s global workforce and represent 50% of the company’s board of directors.
In 2023, MSD achieved greater than 99% parity in compensation between female and male employees, indicated via its global pay equity study of more than 65,000 employees.
In the U.S., the company achieved greater than 99% pay equity by race and gender for the third consecutive year.
In 2023, MSD also defined and introduced 15 new enterprise leadership skills, designed to advance the company’s culture, power organizational and individual performance, and deliver impact for patients, customers and communities.
Environmental Sustainability
In 2024, MSD reaffirmed its dedication to fighting climate change, committing to be net-zero across Scopes 1, 2 and 3 greenhouse gas emissions by 2045, aligned with guidance from the Science Based Targets initiative.
In 2023, MSD sourced 57% of its purchased electricity from renewable sources.
The company has committed to sourcing 100% of its purchased electricity from renewable sources by 2025.
Ethics & Values
MSD increased its spend with small and diverse Tier 1 and 2 suppliers globally from $3.2 billion in 2022 to $3.6 billion in 2023.
In 2023, MSD also added sustainability metrics to its Company Scorecard, which directly affects the payout under its annual incentive plan. The metrics account for 10% of its Company Scorecard and link the compensation for most employees, including executives, to MSD’s performance in driving greater access to health and employee engagement and inclusion. Notably, MSD met all of the goals for these new sustainability metrics in its first year measuring progress against them on its Company Scorecard.
In addition, consistent with its sustainability financing framework, MSD has fully allocated $994 million of the net proceeds from its inaugural sustainability bond to social and green projects. The company issued the bond in 2021 to support its overall sustainability strategy and contribute to advancing the United Nations’ Sustainable Development Goals.
Learn more about MSD’s commitment to sustainability and its approach to creating value for society and all of its stakeholders in the company’s 2023/2024 Impact Report.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies MSD’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases
RAHWAY, N.J., August 7, 2024 – MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) (NYSE: MRK) and Curon Biopharmaceutical (Curon), a privately held biotechnology company, today announced that the companies have entered into a definitive agreement under which MSD, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases.
“We continue to identify opportunities to expand and diversify our pipeline,” said Dr. Dean Y. Li, president, MSD 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, MSD 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. MSD 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, MSD 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. MSD 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, MSD 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 MSD’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.
About Curon Biopharmaceutical
Curon Biopharmaceutical is a clinical-stage company developing bispecific antibodies and antibody-drug conjugates for the treatment of cancer, from both internal research and external collaborations. The company is a Cayman Islands incorporated company with operations in Australia, Hong Kong and Shanghai, China.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.
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).
