Bayer delivers medical innovation fuelling transformation of pharma business

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 diseases, and women’s health.

At the Pharma Media Day, Bayer presented recent advancements for non-steroidal, selective mineralocorticoid receptor antagonist, developed for patients living with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Bayer has a strong scientific and clinical base for the non-steroidal, selective mineralocorticoid receptor antagonist including the largest cardiorenal outcomes clinical trial programme 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, the non-steroidal, selective mineralocorticoid receptor antagonist is being investigated beyond the current indication in heart failure as well as non-diabetic kidney disease as further potential indications. The non-steroidal, selective mineralocorticoid receptor antagonist was approved by the United States Food and Drug Administration (FDA) and granted marketing authorisation in the EU.

This product has also been submitted for marketing authorisation in China, as well as multiple other countries, which are currently under review.

Meanwhile, Bayer’s symptomatic chronic heart failure treatment soluble guanylate cyclase (sGC) stimulator 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 hospitalisations.

The sGC stimulator 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.

The sGC stimulator is jointly developed by Bayer and Merck & Co., Inc. and has been approved by the US FDA, the European Commission, and the Ministry of Health, Labour, and Welfare in Japan. It has also been submitted for market authorisation in China as well as multiple other countries.

“We are currently in the remarkable position to launch several important new medicines and 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.

Another key focus area for Bayer is prostate cancer, the second most commonly diagnosed cancer in men. The company’s franchise includes two products for the treatment of non-metastatic and metastatic prostate cancer.

Based on strong clinical data for darolutamide seen to date, the compound is investigated in a broad development programme with three additional ongoing or planned large clinical studies, to investigate its potential across a broad spectrum of prostate cancer.

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.

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, fuelling its pipeline in the future.

Reimagining radiology

In addition, Bayer is strongly positioned in the fast-growing medical imaging AI market, combining 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.

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.

Shaping women’s health from menarche to menopause

Furthermore, 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 gynaecological diseases with a high unmet medical need, the company is also working on addressing women’s health needs 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 the functional ability and good quality of life is extremely relevant from both a healthcare and a socioeconomic perspective. Unfortunately, menopause remains a taboo topic, leaving many women untreated,” said Cecilia Caetano, 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 programmes 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.

The initiative is part of Bayer’s comprehensive set of sustainability measures and commitments and in line with the UN's Sustainable Development Goals.

Mildred Nadah Pita, head of Global Healthcare Programs and Sustainability Middle Africa at Bayer said, “With Bayer’s commitment to providing 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 SDGs 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 ($448 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.