Bayer Advances Prescription Drug Business Transformation Through Breakthrough Medical Innovations

Berlin, Germany, January 14, 2021 /PRNewswire/ -- At Bayer's global media day for its Prescription Drugs division, held online, the company showcased exciting progress in the transformation of its prescription drug business through breakthrough innovations in pharmaceuticals and healthcare.Will helpCurrently, there are numerous patients suffering from refractory diseases. The company has recently made significant investments in external innovation, completing over 25 collaboration and acquisition projects, a scale unprecedented in its history.

Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division, stated: “The biomedical and technological revolution is driving transformation in healthcare at an unprecedented pace. Bayer is at the forefront of the wave of innovation in cell and gene therapies and digital health. We are also working with our partners to lead this transformation and expand our promising R&D pipeline. Our shared goal is to deliver breakthrough therapies for patients and, looking to the future, to achieve the sustainable development of healthcare systems.”

At Bayer Prescription Drugs Global Media Day, Bayer representatives and partnersand specialtyUnder the theme “Healthcare is Transforming, and So Is Bayer,” the company elaborated in detail on Bayer’s ambitious strategic goals in the fields of cell and gene therapy and digital health, and demonstrated its commitment to improving patient health by advancing a promising research and development pipeline.

Cell and Gene Therapy: Accelerating Breakthrough Innovations to Serve Patients

Cell and gene therapy offers the first-ever possibility of addressing the root causes of diseases, providing options for conditions that are difficult to cure or for which current standard treatments only alleviate symptoms to varying degrees. Bayer’s increasing investments have consolidated its nascent leadership in this field and underscored its strategic importance as a key driver of growth for its pharmaceuticals business.

Bayer’s newly established Cell and Gene Therapy Platform is designed to provide strategic direction for the company’s initiatives in this field and coordinate all activities across the value chain, fostering an innovative ecosystem for all partners, including BlueRock and AskBio. These two companies are currently wholly owned by Bayer but continue to operate independently. Bayer’s research and development pipeline in cell and gene therapy already comprises seven leading assets at various stages of clinical development. These R&D programs target multiple therapeutic areas with high unmet medical needs, such as neurodegenerative diseases, neuromuscular disorders, and cardiovascular diseases, featuring leading projects in Pompe disease, Parkinson’s disease, Hemophilia A, and congestive heart failure. With more than 15 preclinical assets in cell and gene therapy, the company’s R&D pipeline is poised for steady year-over-year growth.

Wolfram Carius, Executive Vice President of Bayer Pharmaceuticals and Head of the Cell and Gene Therapy area, stated: “Cell and gene therapies hold the promise of significantly improving patients’ quality of life by shifting the focus from symptomatic treatment to potentially curative approaches. We aim to collaborate with partners to accelerate innovation across the entire value chain—from source to delivery—ensuring that scientific advancements are rapidly translated into therapies for patients with urgent unmet medical needs.”

BlueRock Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug application to conduct a Phase I study in patients with Parkinson’s disease. This will be the first trial in the United States to investigate pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease, marking a significant advancement in the field of stem cell therapy.

Digital Health: withEmpowering Patients with Integrated Healthcare

Digital health services have become a key pillar of modern healthcare. By combining traditional medical approaches with innovative digital technologies, efficient solutions can be delivered to meet individuals’ needs in specific contexts. Bayer is developing and establishing the concept of integrated care to provide personalized support for patients. This personalized approach helps address the complex and interconnected health challenges faced by individuals.

Integrated care is a key component of Bayer Prescription Drugs’ digital business strategy. Bayer is collaborating with the digital health company Informed Data Systems Inc. (IDS/One Drop) to expand services built upon IDS’s existing diabetes management platform, which has already surpassed 3 million downloads. The two companies are currently co-developing new health service offerings to address patient needs in the areas of cardiovascular disease, women’s health, and oncology. Experts from both organizations are jointly developing the first two modules, which are expected to launch within the next year.

Jeanne Kehren, Member of the Global Executive Committee of Bayer Pharmaceuticals and Senior Vice President of Digitalization and Commercial Innovation, stated, “By focusing on individual patients rather than solely on their diseases, integrated healthcare offers a tangible pathway to achieving inclusive and personalized medicine. We are committed to making integrated healthcare solutions a key pillar of our pharmaceuticals business. Leveraging our expertise in the pharmaceutical sector, we can bridge the gap between technology and healthcare. We anticipate that digital healthcare service products will make a significant contribution to our revenue over the next decade.”

Driving a Robust R&D Pipeline: Delivering Novel Approaches to Unmet Medical Needs

Bayer is continuously building a robust R&D pipeline, currently comprising over 50 clinical projects focused on cardiovascular diseases, oncology, and women’s health. Bayer highlighted two mid-stage development projects with broad prospects, demonstrating its level of medical innovation.

Bayer is an innovation leader in the field of cardiovascular disease, with a profound understanding of these conditions and a long history of successful drug development, particularly demonstrating strong capabilities in the antithrombotic area. Heart disease and stroke remain major disease burdens, creating a need for new and more effective therapeutic options to prevent thrombosis. The company is advancing a promising mid-stage program targeting factor XI (FXI), a novel class of anticoagulants comprising three investigational assets. A small-molecule oral FXIa inhibitor has entered its Phase IIb clinical trial program (PACIFIC), which plans to enroll more than 4,000 patients in total. Additionally, an anti-FXIa antibody and an FXI ligand-conjugated antisense oligonucleotide (FXI-LICA), both developed by Bayer under an exclusive license from Ionis Pharmaceuticals, have recently initiated Phase II trials in patients with end-stage renal disease. Inhibition of the FXI pathway can prevent thromboembolic events without increasing the risk of bleeding, thereby providing treatment options for patients who currently lack suitable therapeutic alternatives.

Bayer to Focus on Key Mid-Stage Candidate Drug P2X3 and Its Multi-Indication Development ProgramAs part of its strategic research alliance with the German drug development company Evotec, Bayer has identified the development of P2X3 antagonists for the treatment of endometriosis. Endometriosis is a clinical condition affecting approximately 10% of women of reproductive age, many of whom experience severe chronic pain that impacts their work, personal, and social lives. P2X3 antagonists have also demonstrated efficacy in other conditions associated with pain and neurogenic hypersensitivity, such as chronic cough, overactive bladder, and neuropathic pain. Although these conditions are not life-threatening, they significantly impair the quality of life for many patients. P2X3 antagonists may offer new therapeutic options for these individuals.In terms of drug development strategy, Bayer has decided to pursue an innovative R&D pathway by simultaneously exploring multiple potential indications, rather than a single one, during the early clinical stages. Currently, Bayer has entered Phase IIb clinical trials for refractory and/or unexplained chronic cough, with trials for endometriosis to follow shortly. Additionally, Phase IIa clinical studies for overactive bladder and diabetic neuropathic pain have already commenced.

Stefan Oelrich stated, “Our research in the fields of Factor XI inhibitors and P2X3 antagonists represents just two highly promising examples among the company’s numerous mid-stage projects, underscoring our continuous efforts and commitment to building and advancing a robust R&D pipeline. Bayer aims to position itself as a leader in the highly advanced field of pharmaceutical and healthcare innovation. We continue to play a pioneering role, consistently providing new solutions for patients in need.”

Meanwhile, the company’s late-stage R&D pipeline in oncology and cardiovascular diseases has also yielded substantial results, including many potential blockbuster products. For example, in the field of oncology, darolutamide (co-developed with Orion Corporation) is a differentiated treatment regimen that extends survival in male patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, and has demonstrated a favorable safety profile. This product has received regulatory approval in multiple markets, including the United States, the European Union, Brazil, Canada, and Japan. The Phase III study “ARASENS” for the indication of metastatic hormone-sensitive prostate cancer (mHSPC) is expected to announce its results in 2021. Larotrectinib is the first precision oncology therapy approved for the treatment of patients with solid tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions.^[1]. The product has been approved in more than 40 countries/regions, including the United States and EU countries/regions. It is the first tumor-agnostic therapy in the European Union.

Finerenone is a novel class of investigational drug designed for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), a condition characterized by significant unmet medical needs and limited treatment options. Based on data from the Phase III FIDELIO-DKD clinical trial, marketing authorization applications for finerenone have been submitted in the United States and the European Union. The Phase III clinical development program for finerenone represents the largest such initiative conducted to date in the population of patients with CKD and T2D. This program comprises two studies aimed at evaluating the renal and cardiovascular benefits of finerenone compared with placebo plus standard of care; the second Phase III trial, FIGARO-DKD, is still ongoing. Vericiguat is a drug co-developed by Bayer and Merck & Co. (known as MSD outside the United States and Canada, and as Merck in the United States and Canada), currently under development for the treatment of patients with chronic heart failure with reduced ejection fraction. Vericiguat effectively restores the function of a specific signaling pathway that is not targeted by current therapies. Marketing authorization applications for vericiguat have been submitted in multiple countries and regions, including the United States, the European Union, Japan, and China. In July 2020, the new drug application for vericiguat for the treatment of chronic heart failure entered the Priority Review program of the U.S. Food and Drug Administration (FDA).

In the field of women's health, Bayer recently acquired KaNDy Therapeutics, adding a highly attractive asset to its R&D pipeline. BAY-342 (formerly NT-814) is an advanced, non-hormonal, once-daily oral neurokinin 1 and 3 receptor antagonist for the treatment of menopausal vasomotor symptoms (hot flashes and night sweats), with Phase III development planned to commence in 2021.

[1] Larotrectinib is the first precision oncology drug indicated for the treatment of adult and pediatric patients with solid tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions, who have locally advanced, metastatic, or surgically unresectable disease, or whose disease has progressed following surgery, and who have no satisfactory alternative treatment options.

About Bayer

As a multinational corporation, Bayer possesses core competencies in health and nutrition within the life sciences sector. The company is dedicated to helping people overcome the major challenges posed by global population growth and aging through its products and services, thereby benefiting humanity. Meanwhile, the Group enhances profitability and creates value through technological innovation and business growth. Bayer is committed to sustainable development. Globally, the Bayer brand stands for trust, reliability, and quality. In the 2019 fiscal year, Bayer employed approximately 104,000 people, recorded sales of €43.5 billion, capital expenditures of €2.9 billion, and research and development investments of €5.3 billion. For more information, please seewww.bayer.com 

Forward-Looking Statements 

This press release contains forward-looking statements made 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 future operating results, financial position, development, or performance to differ materially from the estimates presented in such forward-looking statements. These factors include those disclosed on Bayer’s official websitehttp://www.bayer.com/Bayer’s various reports publicly disclosed. The Company has no obligation to update these forward-looking statements or to conform them to future events or developments.