Bayer Pharmaceuticals Accelerates Development of Next-Generation Blockbuster Drugs

Latest Data on Elinzanetant Lays a Solid Foundation for Submission to Regulatory Authorities

Strengthening Cardiovascular Portfolio, Bayer Obtains Exclusive Commercialization Rights for Acoramidis in Europe

Nubeqa for Prostate Cancer^®(Darolutamide) is expected to become a blockbuster drug in 2024

Launch of Aflibercept 8mg (Eylea 8mg) May Reshape the Treatment Standard for Retinal Diseases

Fully enrich the R&D pipeline and submit eight new drug Investigational New Drug (IND) applications in 2023.

Four drugs with first-in-class potential are expected to enter Phase II clinical trials by the end of 2024.

Advance Clinical Trials for Seven Cell and Gene Therapy Projects, Focusing on Parkinson's Disease and Congestive Heart Failure

Has invested 3.5 billion euros in establishing a technology platform for the research and development of cell and gene therapies.

Berlin, March 21, 2024 ——At Bayer Pharmaceuticals' 2024 Global Media Day, Bayer showcased the latest progress in the transformation of its pharmaceuticals business. This transformation is part of Bayer Pharmaceuticals' strategic initiative aimed at promoting long-term, sustainable development.

"We have made significant progress in enhancing the value of our R&D pipeline, which shows that our adjusted R&D strategy is working," said Stefan Oelrich, member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division. "Bayer continues to strengthen its influence in key therapeutic areas and has made remarkable progress in fully leveraging the potential of marketed products."

Specifically, Bayer has strengthened its innovative drive, focusing its research efforts on four core therapeutic areas (cardiovascular diseases, oncology, immunology, neurology, and rare diseases). At the same time, it has extended its expertise through collaborations and acquisitions, while enhancing the quality of its R&D pipeline with a well-planned product portfolio. In 2023, Bayer advanced its R&D pipeline by submitting eight new drug clinical trial applications. Additionally, four drugs with first-in-class potential are expected to enter Phase II clinical trials by the end of 2024.

"In the past 24 months, we have been intensifying our R&D efforts and have made significant progress in rebuilding a healthy R&D pipeline," said Christian Rommel, member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development. "We will continue to achieve this goal with a sense of urgency, particularly by increasing new drug clinical trial applications, gaining more contributions from platform companies, and continuously seeking attractive new external partners or deals."

In early March, Bayer obtained the exclusive commercialization rights for acoramidis in Europe. Acoramidis is an oral, potent, and highly selective small molecule transthyretin stabilizer used for treating transthyretin amyloid cardiomyopathy (ATTR CM). In a Phase III clinical trial, acoramidis met all clinical endpoints. Its marketing authorization application has been submitted to the European Medicines Agency.

Latest Data on Elinzanetant Lays a Solid Foundation for Submission to Regulatory Authorities

By advancing innovative therapies, Bayer is committed to expanding treatment options and elevating the standard of care for women in menopause. Elinzanetant, a compound in Bayer's late-stage development pipeline, is the first non-hormonal treatment and a dual neurokinin-1,3 (NK-1,3) receptor antagonist, administered orally once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause. The pivotal Phase III clinical trials OASIS 1, 2, and 3 have recently achieved positive topline results. Bayer will submit these encouraging data to relevant pharmaceutical regulatory authorities. Elinzanetant has blockbuster potential and is expected to launch in 2025.

"Vasomotor symptoms during the menopausal transition can significantly impact quality of life for women, and the results from the elinzanetant OASIS 1, 2, and 3 studies are encouraging news for those experiencing these symptoms," said Cecilia Caetano, Global Medical Affairs Head of Women's Health at Bayer's Pharmaceuticals Division. "We are working to advance science and support women at all stages of life through education, awareness, and expanding treatment options."

By 2030, the global female population in menopause is expected to increase to 1.2 billion, with an additional 47 million women each year. More than one-third of women in menopause experience severe symptoms, which can persist for 10 years or longer after the final menstrual period and accordingly impact their quality of life. However, approximately 30% of women who seek medical consultation due to moderate to severe symptoms do not receive any treatment.

Nubeqa^®Will continue to grow

Bayer continues to advance on its path to becoming a leading company in the field of oncology treatment. A key product for Bayer in this area is Nubeqa.^®, the product will continue to grow in the field of prostate cancer. Although it has only been five years since the launch of the first indication, Nubeqa...^®Expected to gain the status of a blockbuster drug this year. Nubeqa^®Is the fastest-growing androgen receptor inhibitor in the United States and has also gained approval for marketing and indication applications in many other countries. As the next significant data source, the ARANOTE trial is expected to be completed this year. More trial data from ARASTEP and DASL-HiCAP are expected to expand the indications to earlier stages of the disease, benefiting more patients annually with Nubeqa.^®The number of patients will increase.

"In addition to maintaining the vitality of our existing oncology portfolio, we have also enhanced our precision oncology development capabilities, unlocking the next generation of breakthrough therapies and establishing a robust and sustainable R&D pipeline in the fields of tumor intrinsic signaling pathways, immuno-oncology, and targeted radiopharmaceuticals," said Dr. Dominik Ruettinger, Global Head of Oncology Research and Early Development at Bayer Pharmaceuticals. "To address unmet medical needs in the field of cancer, we are pushing the boundaries of innovation to deliver effective drugs tailored to the individualized treatment needs of patients."

Besides cardiovascular diseases, cancer is the leading cause of death worldwide. Despite advancements, the number of cancer-related deaths continues to rise. Observations indicate that the demographic of cancer patients is changing, with an increasing number of patients being younger at the time of initial diagnosis and more patients being diagnosed at earlier stages of the disease. These patients require effective and "more friendly," better-tolerated drugs, as well as therapies capable of overcoming drug resistance.

Bayer has made significant investments in innovation within this field, striving to expand the druggable target library aimed at the true vulnerabilities of cancer and accelerate the drug development process. Through the acquisition of Vividion and its industry-leading chemoproteomics platform, Bayer has strengthened its drug research and pipeline in the small molecule and precision treatment areas. Vividion's innovative technology can identify previously unknown binding pockets on "undruggable" targets, enabling the development of new candidate drugs for indications with unmet medical needs. In the past six months, Vividion has advanced two high-profile cancer projects (KEAP 1 activator and STAT 3 inhibitor) into Phase I clinical trials.

In February, the U.S. Food and Drug Administration (FDA) granted Bayer's investigational drug BAY 2927088 Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations. This program stems from a long-term research collaboration between Bayer and the Broad Institute, a renowned academic institution affiliated with the Massachusetts Institute of Technology (MIT) and Harvard University. The drug is currently in Phase I/II clinical trials.

On March 20, Bayer and Thermo Fisher Scientific announced a collaboration to co-develop next-generation sequencing-based companion diagnostic tests for Bayer’s growing portfolio of precision oncology products.

Accelerate the R&D Pipeline of Cell and Gene Therapies

Cell and gene therapies bring new, potentially transformative treatment approaches, with the hope of halting or reversing diseases through a single administration. From early research to establishing manufacturing capabilities and platforms, and ultimately achieving drug accessibility, Bayer's continued investment in this field highlights the importance of cell and gene therapies as a growth driver for prescription medicines, demonstrating Bayer's commitment to translating these innovations into therapies that benefit patients.

Bayer and its subsidiaries BlueRock and AskBio are advancing a portfolio of products in preclinical and clinical stages. These competitive cell and gene therapies include seven projects at various clinical stages, focusing on areas with the highest medical needs.

AskBio's gene therapy candidate AB-1002 has recently entered Phase II clinical trials to evaluate the efficacy and safety of a single dose of AB-1002 in treating congestive heart failure, which affects approximately 26 million people worldwide. BlueRock Therapeutics released data on its investigational therapy bemdaneprocel (BRT-DA01) after 18 months of treatment in Parkinson’s disease patients. The Phase I clinical trial is still ongoing, with data showing positive trends. These results also support plans to initiate a Phase II clinical study in 2024. Another gene therapy candidate is expected to enter Phase II trials for Parkinson’s disease patients later this year.

"Cell therapy and gene therapy are two of the fastest-growing and most competitive fields in modern medicine. Since 2020, Bayer has invested more than 3.5 billion euros in building related technology platforms for the research and development of cell and gene therapies," said Christian Rommel, member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development. "We are excited about the significant progress made in our diverse and leading therapy platforms. We believe that these early-stage projects will bring tangible benefits to patients in the future."

Expand Influence in Key Therapeutic Areas

With an innovative product portfolio, Bayer is expanding its influence in key therapeutic areas such as cardiovascular, oncology, women's health, radiology, and ophthalmology.

This year, Aflibercept 8mg has been successively approved in major markets such as the European Union, Japan, Canada, and the United Kingdom. Bayer is confident in maintaining its market leadership in the field of retinal diseases and hopes that Aflibercept 8mg will redefine the treatment standards for retinal diseases based on its unique clinical advantages. As the only drug currently offering a treatment interval of up to 5 months, Aflibercept 8mg addresses the significant unmet need of ophthalmologists and patients for longer treatment intervals. Compared with Aflibercept 2mg (Eylea 2 mg), which is administered every 8 weeks, Aflibercept 8mg reduces the number of injections and patient visits, freeing up scarce medical resources and enhancing the potential for optimized patient care.

Another key growth driver for Bayer's prescription drugs is Kerendia.^®(Finerenone). This product has been approved in more than 85 countries worldwide for the treatment of chronic kidney disease associated with type 2 diabetes. Finerenone has the potential to become a foundational treatment option for a broader population of patients with kidney disease and/or heart failure. The product continues to perform well in the field of chronic kidney disease associated with type 2 diabetes, particularly in the U.S., China, and Mexican markets. The FINEOVATE research program for Finerenone is ongoing, and as this study generates more data over the next four years, Bayer will further validate the efficacy of Kerendia.^®Enormous potential.

Building on its tradition of innovation in the cardiovascular field, Bayer is confident in further improving treatment for cardiovascular patients. The Phase III OCEANIC trial of Asundexian for secondary stroke prevention is progressing rapidly. Additionally, Bayer is focused on precision cardiology, aiming to address the significant disease burden in the cardiovascular space. One example is the anti-α2-antiplasmin antibody, which is currently in Phase II clinical trials as a treatment option in deep vein thrombosis patients, evaluating its feasibility for highly medically relevant indications.

In the field of imaging diagnostics, Bayer is advancing the Phase III clinical development program QUANTI for its novel investigational macrocyclic gadolinium-based contrast agent (GBCA), gadoquatrane, with progress exceeding expectations. Compared to the standard dose of existing macrocyclic GBCAs, gadoquatrane has the potential to significantly reduce the clinical gadolinium (Gd) dose required for patients undergoing enhanced magnetic resonance imaging (MRI) scans.

About Bayer

Bayer, as a multinational enterprise, possesses core competencies in the fields of health and agriculture within the life sciences sector. Guided by the mission of "Health for All, Hunger for None," the company is committed to helping people overcome major challenges posed by global population growth and aging through its products and services, benefiting humanity and fostering the prosperity of our planet. Bayer is dedicated to promoting sustainable development and creating a positive impact on its business. At the same time, the group enhances profitability and creates value through technological innovation and business growth. Globally, the Bayer brand stands for trust, reliability, and quality. In the 2023 fiscal year, Bayer employed approximately 100,000 people and generated sales of €47.6 billion. Research and development expenditure, excluding special items, amounted to €5.8 billion. For more information, please visit www.bayer.com.

Forward-Looking Statements

This press release includes forward-looking statements by the management of Bayer AG based on current assumptions and forecasts. Various known and unknown risks, uncertainties, and other factors could cause the company's actual operational results, financial condition, development, or performance to differ materially from the estimates made in the above forward-looking statements. These factors are disclosed in Bayer’s various reports available on the company’s website at www.bayer.com. The company does not have any obligation to update these forward-looking statements or adapt them to future events or developments.