Bayer delivers on medical innovation fueling transformation of pharma business

BayerAt its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.

"We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Our leadership in cardiology, radiology and women's health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients," said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer's Pharmaceuticals Division. "We are excited to see our efforts crystalize in our latest product launches, which include two potential blockbusters, as well as a late-stage portfolio with at least another blockbuster opportunity."

Bayer's research and development pipeline continues to grow as the company is building on its existing competencies, such as the expertise around small molecules, while expanding into new modalities, including cell and gene therapies. The company is advancing around 50 projects in ongoing clinical trials across a range of potential therapeutic modalities and indications, with a focus on oncology, cardiovascular and women's health.

Strong pipeline with robust late-stage development program and broad potential across indications

In the area of cardiovascular disease, Bayer is delivering on its late-stage pipeline including recent launches of Kerendia™ (finerenone) and Verquvo™ (vericiguat).

The heart and the kidneys are closely linked in health and disease. Chronic kidney disease (CKD) in type 2 diabetes (T2D) is the leading cause of end-stage kidney disease with many patients at advanced stages needing dialysis or a kidney transplant to stay alive. Patients are also three times more likely to die from a cardiovascular event than those with T2D alone, so early diagnosis and treatment is important to slow CKD progression and prevent poor patient outcomes. It is estimated that CKD affects more than 160 millionpeople with T2D worldwide. At the Pharma Media Day, Bayer presented recent advancements for finerenone (Kerendia™), developed for patients living with CKD associated with T2D. In this field, Bayer has a strong scientific and clinical base for finerenone, including the largest Phase III cardiorenal outcomes clinical trial program to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal cardiovascular events in more than 13,000 patients with CKD and T2D. Additionally, finerenone is being investigated beyond the current indication in heart failure as well as non-diabetic kidney disease as further potential indications. Finerenone was approved under the brand name Kerendia® by the United States (U.S.) Food and Drug Administration (FDA), and just recently was granted marketing authorization in the European Union. Finerenone has also been submitted for marketing authorization in China, as well as multiple other countries worldwide and these applications are currently under review.

Heart failure is a devastating disease affecting more than 60 million people worldwide, who are in need of treatment options. Bayer's symptomatic chronic heart failure treatment vericiguat (Verquvo™) provides a specific approach to managing chronic heart failure patients following a recent decompensation event, also known as a worsening heart failure event. A worsening heart failure event can mark the start of a downward spiral of disease progression and repeated hospitalizations. In fact, 56% of patients are back in hospital within 30 days. Vericiguat works in conjunction with existing approaches through a different mode of action. It restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure, aggravating its symptoms. Vericiguat is jointly developed by Bayer and MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA), known as Merck in the U.S., and has been approved by the U.S. Food and Drug Administration (FDA), the European Commission and the Ministry of Health, Labour, and Welfare (MHLW) in Japan among other countries. Vericiguat has also been submitted for marketing authorization in China as well as multiple other countries worldwide.

"We are currently in the remarkable position to launch several important new medicines in parallel, and we are unlocking the full potential of our assets through systematic data generation, multi-indication approaches as well as building on new digital business models," said Christian Rommel, Member of the Executive Committee of Bayer's Pharmaceutical Division and Head of Research and Development. "Our scientific leadership in the area of cardiovascular diseases advances our mission to provide better treatment options for patients in need."

Bayer's efforts in oncology focus on differentiated approaches that have the potential to fundamentally impact the way that cancer is treated. With three product launches over the last five years, Bayer has significantly broadened its footprint in the area, focusing on those areas with the highest unmet medical need while applying a broad range of modalities.

A key focus area for Bayer is prostate cancer, the second most commonly diagnosed cancer in men. The company's franchise includes two products on the market (Nubeqa™, active ingredient darolutamide) and Xofigo™ (radium-223 dichloride) for the treatment of non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC and mCRPC, respectively). Based on strong clinical data for darolutamide seen to date, the compound is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to investigate its potential across a broad spectrum of prostate cancer. Amid positive data from the Phase III ARASENS trial Bayer recently raised peak sales expectations for Nubeqa to exceed €3 billion. The use of radium-223 dichloride in mCRPC is explored in three additional large Phase III studies. With these products as well as additional compounds in development, Bayer is aiming to provide treatments that extend the lives of prostate cancer patients throughout the different stages of the disease and allowing them to continue their everyday activities so that they can live longer, better lives.

At the same time, the company continues to invest in areas that have the potential to address additional unmet needs in cancer, including targeted radiopharmaceuticals, specifically targeted alpha therapies, next-generation immuno-oncology including oncology cell therapy, as well as precision molecular oncology approaches. Combining Bayer's expertise in small molecules with the recently acquired chemoproteomics technology platform from Vividion will allow the company to unlock traditionally undruggable oncology targets, fueling its pipeline in the future. External innovation will continue to play a vital role in Bayer's pipeline growth, positioning the company to become a future leader in key segments of the oncology market.

"With our differentiated prostate cancer treatment darolutamide, which has shown a strong clinical benefit in two large Phase III studies in prostate cancer and has a broad development program underway in various other stages of the disease, we are laying the foundation now for continued growth in the future and become a top-10 oncology company by 2030," said Robert LaCaze, member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "In addition, we have broadened our approach with several new platforms, and launched the precision oncology treatment Vitrakvi™ (larotrectinib). With six products across ten indications, Bayer is already today delivering new treatments for cancer patients who need additional and better options. With our track record in developing and launching innovative oncology products and our rich pipeline, we are confident that we have all the ingredients for long-term success."

Re-imagining Radiology

Bayer is strongly positioned in the fast-growing medical imaging artificial intelligence (AI) market, combining a long-term expertise in radiology with a deep understanding of patients' and physicians' needs across a broad range of diseases, from oncology to cardiovascular, resulting in the ability to provide know-how and solutions from diagnosis to care.

In times of limited resources in healthcare systems, growing as well as aging populations and changing lifestyles contribute to an increase in chronic conditions such as cardiovascular disease and cancer. As a result, the need for tools delivering improved diagnostic information while helping save costs and time is increasing. Tackling this challenge with advanced technologies and products, radiology is a key enabler to transform healthcare, expanding personalized medicine and improving outcomes for patients. In particular, AI bears vast potential for advancing radiology.

Bayer is developing a platform through which healthcare professionals can centrally manage AI-enabled medical imaging and imaging workflow applications. These solutions are being developed by Bayer as well as third parties, and aim to support the complex decision-making processes of healthcare professionals in their task to provide a clear direction from diagnosis to care for their patients.

"One of the most pressing concerns in medical imaging today is the exponential growth of imaging data and its complexity due to an increase in radiology examinations, and the shortage of experienced medical staff to handle it," said Zuzana Jirakova Trnkova, MD, PhD, Head of Medical Affairs and Clinical Development Radiology at Bayer. "Artificial intelligence can be a valuable tool that, when complementing the human expertise of radiologists and clinicians, offers vast potential to the healthcare industry and radiology in particular. This is why Bayer strives to be a key digital innovator in this area, with the ultimate goal of improving outcomes for patients and supporting their physicians."

Shaping women's health from menarche to menopause

Bayer has a long-standing commitment to delivering solutions to meet women's needs across the different stages of their lives. While pursuing research to find new treatment options for gynecological diseases with a high unmet medical need, the company is also working on addressing women's health needs during menopause. Elinzanetant, a non-hormonal development compound, is currently being investigated in the Phase III clinical development program OASIS for the treatment of vasomotor symptoms during menopause.

"Every year 47 million women enter menopause, a period where women are at the peak of their life's activity, personally and professionally. With increased longevity, maintaining functional ability and good quality of life is extremely relevant from both a healthcare and a socio-economic perspective. Unfortunately, menopause remains a taboo topic, leaving many women untreated," said Cecilia Caetano, MD, Head of Medical Affairs Menopause at Bayer. "With our strong heritage and deeply rooted expertise in women’s health, we continue to focus on providing innovative science, solutions and education to support the individual health need of women."

Increasing access to modern contraception

For more than 50 years, Bayer has supported educational programs and rights-based family planning in more than 130 countries, particularly by increasing access to modern forms of contraception. In 2019, Bayer pledged to provide 100 million women in low- and middle-income countries with access to family planning by 2030. This initiative is part of Bayer's comprehensive set of sustainability measures and commitments (1) and in line with the United Nations Sustainable Development Goals (UN SDGs) (2).

"We believe every girl and woman deserves the chance to determine her own future. That's why Bayer is partnering with local and international organizations, such as the United Nations Population Fund and the United States Agency for International Development, to empower women to make informed decisions about family planning," said Mildred Nadah Pita, Head of Global Healthcare Programs/Sustainability Middle Africa at Bayer. "With Bayer's commitment to provide 100 million women in low- and middle-income countries with access to modern contraception by 2030, we are making an important contribution to achieving the UN Sustainable Development Goals by improving the health, rights and economic status of women around the world, which is a fundamental prerequisite for greater equality, education and prosperity for all."

As part of this commitment, Bayer recently announced an investment of over €400 million in new production facilities for long-acting reversible contraceptives, including the construction of a new production site in Alajuela, Costa Rica and the expansion of production capabilities in Turku, Finland.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros.

1. https://www.bayer.com/en/sustainability/targets
2. https://sdgs.un.org/goals

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