Bayer Showcases the Latest Progress in the R&D Pipeline of Prescription Drugs, Promotes Medical Innovation and Facilitates Business Transformation

At its recent Prescription Drugs Global Media Day 2022, Bayer showcased the latest progress in the ongoing transformation of its prescription drug business, which aims to achieve long-term, sustainable business growth by providing patients with new treatment options.

"We are making bold strides into the future of drug development, investing heavily in the forefront of biomedical and technological revolutions."

Bayer has long been recognized globally in the fields of cardiology, diagnostic imaging and women’s health, and we are also actively expanding our business in the field of oncology, working tirelessly to bring new treatments to patients and improve current treatment modalities," said Stefan Oelrich, Member of the Bayer Group Management Board and Global President of Bayer's Prescription Medicines division.

"Our work is already reaping the benefits of the latest launches. These include two potential blockbusters, with at least one potential blockbuster in the late-stage portfolio."

Bayer's R&D pipeline continues to grow as Bayer builds on existing competitive strengths (such as expertise in small molecule therapeutics) and expands into new treatment modalities, including cell and gene therapy.

Bayer is currently conducting approximately 50 clinical trial programs covering different potential treatment modalities and multiple indications, with a focus on oncology, cardiovascular and women's health.

Robust R&D pipeline with multiple late-stage development projects with potential across different indications

In the field of cardiovascular disease, Bayer is actively advancing key advances in its late-stage R&D pipeline, including feneridone and veliciguat, which have submitted marketing applications in China.

The heart and kidneys are closely related in health and disease. Chronic kidney disease with type 2 diabetes is the leading cause of end-stage renal disease, and many patients with advanced stages require dialysis or kidney transplantation to stay alive.

At the Global Media Day for Prescription Drugs, Bayer introduced the strong scientific and clinical foundation for feneridone, including a phase III clinical trial with cardiorenal benefit as the endpoint, targeting 13,000 patients with chronic kidney disease type 2 The drug was evaluated in patients with diabetes to delay the progression of kidney disease and reduce the incidence of fatal and non-fatal cardiovascular events. Feneridone has been approved by the U.S.

Food and Drug Administration (FDA) and recently received marketing authorization in the European Union. Feneridone has submitted marketing applications in China and many countries and regions around the world, and is currently under approval.

Heart failure is a serious disease that affects more than 60 million patients worldwide, and they need more treatment options.

Bayer's drug Vericiguat for symptomatic chronic heart failure offers a unique approach to the management of chronic heart failure patients with a recent history of decompensated events, also known as exacerbations. This pathway plays a key role in the progression of heart failure and its worsening symptoms.

Veliciguat has been approved by national regulatory agencies including the U.S. Food and Drug Administration and the European Commission. Velixigua has also submitted listing applications in China and many countries and regions around the world.

In the field of oncology, Bayer's work focuses on differentiated approaches that have the potential to disrupt the way cancer is treated.

Bayer has launched three products in the past five years, vigorously broadening its practice in the field of oncology, applying multiple treatment modalities, and focusing on areas where medical needs are not met.

Prostate cancer is the second most common cancer diagnosed in men worldwide, and it is one of Bayer's key areas of focus.

Bayer's related businesses include two marketed products, Noberger (the active ingredient is dalotamide) and Dofigo (radium chloride [223Ra]), for the treatment of non-metastatic and metastatic castration-resistant prostate cancer ( nmCRPC and mCRPC, respectively).

Based on the current positive clinical data related to darotamide, Bayer is investigating the compound through an extensive development program that includes 3 additional large clinical studies, ongoing or planned, to evaluate its use in the treatment of prostate cancer.

Broad potential. Based on positive data from the Phase III clinical trial ARASENS, Bayer has recently raised the potential peak sales of Nobergo to 3 billion euros.

At the same time, Bayer continues to invest in areas of cancer treatment that have the potential to address other unmet needs, including targeted radiopharmaceuticals (especially targeted alpha therapy), next-generation immuno-oncology (including tumor cell therapy), and precision Molecular Oncology Therapy.

By combining its expertise in small molecules with the chemical proteomics technology platform acquired by the recent acquisition of Vividion, Bayer can unlock previously undruggable tumor targets, thereby providing future momentum for the company's research and development pipeline.

Leading women's health innovation

As a recognized leader in women's health, Bayer is committed to providing innovative solutions to meet the needs of women at different stages of life.

Through research, Bayer not only discovers novel treatment options for high unmet medical needs in the field of gynecological diseases, but also addresses the health needs of menopausal women.

Elinzanetant is a compound in development for non-hormonal therapy. The ongoing Phase III clinical development program, the OASIS study, is designed to evaluate the efficacy and safety of Elinzanetant in the treatment of menopausal vasomotor symptoms.

In China, Bayer has continued to bring more innovative gynecological treatments to local female patients for many years. In 2019, a new drug for endometriosis treatment, Weisanning (dienogest tablets), was approved for marketing in China.

As the world's first progestin developed specifically for the treatment of endometriosis, the drug provides an effective, generally well-tolerated endometriosis treatment option that reduces pain and shrinks lesions , reduce postoperative recurrence rate, improve the quality of life of female patients, thereby promoting and protecting fertility.

In January this year, dienogest tablets were recommended by the "Third Edition Guidelines for the Diagnosis and Treatment of Endometriosis" as the drug of choice for the long-term management of endometriosis, and it is expected that more Chinese female patients can benefit from it.

Looking ahead to imaging diagnosis

The limited resources of the current medical and health system, the continuous growth and aging of the population, and the changing lifestyles are all leading to an increasing incidence of chronic diseases such as cardiovascular disease and cancer.

As a result, there is an increasing demand for tools that provide better diagnostic information while helping to save costs and time. Diagnostic imaging can meet this challenge with advanced technologies and products, thus becoming a key enabler to fundamentally transform healthcare, expand individualized care, and improve patient outcomes.

With its long-term expertise in radiology, combined with a deep understanding of the needs of patients and doctors for different diseases, from tumor to cardiovascular, Bayer can provide comprehensive technologies and solutions from diagnosis to treatment.

Bayer is developing a platform through which healthcare professionals can centrally manage medical imaging and imaging workflow applications powered by artificial intelligence. The solutions, jointly developed by Bayer and third parties, are designed to support healthcare professionals in decision-making in the complex process of diagnosis and treatment, providing patients with clear guidance from diagnosis to treatment.