Stefan Oelrich, President of Bayer Pharmaceuticals: Multidimensional Empowerment Accelerates Realization of Medical Breakthroughs

In recent years, as new technologies such as antibody conjugation, mRNA, and gene editing have matured, emerging therapies like ADC drugs, CAR-T therapy, gene therapy, and small nucleic acid drugs have continuously emerged. These therapies either fill the clinical treatment gap for rare diseases with no available treatments or revolutionize disease treatment patterns, and in some cases, create curative opportunities for patients... These groundbreaking technological breakthroughs are turning "impossibilities" into "possibilities."

On March 21, Bayer launched the 2024 Global Media Day for its pharmaceuticals division under the theme "The Future is Now: Achieving Breakthroughs in Healthcare Innovation." Senior executives from Bayer's pharmaceuticals division, experts from various fields, and patient representatives gathered in Berlin, Germany. They focused on discussing the latest trends in healthcare, Bayer’s cutting-edge innovations in women's health, oncology, cell and gene therapies (CGT), as well as the challenges and opportunities faced, and how to successfully translate medical breakthroughs into reality.

Stefan Oelrich, Global President of Bayer Prescription Drugs

On March 5, Bayer AG released its 2023 financial report, showing a total group revenue of 47.637 billion euros, with prescription drug sales remaining flat year-on-year at 18.081 billion euros. This somewhat "stagnant" performance has inevitably raised concerns about the future growth of its prescription drug business.

Stefan was straightforward about this: "The impending loss of the Xarelto patent will indeed have a certain impact on Bayer's prescription drug business, but it is manageable and can be addressed."Besides, I would like to add,The expiration of a drug's patent can have such a significant impact on the overall business, which also indirectly reflects the great success of this product.”

To achieve sustainable business growth, Bayer has proactively planned its development path, which is mainly divided into three parts. The first is to cultivate new blockbuster drugs, and implement long-life cycle management for already marketed drugs such as Nubeqa, Kerendia, and Eylea 8mg, fully tapping their potential value to extend their life cycles. For multiple late-stage products like elinzanetant, asundexian, and acoramidis, the focus is on rapidly advancing commercialization to realize their clinical value.

He emphasized,These products form the foundational business of Bayer, with a scale of 10 billion euros, and also serve as the stable base of its prescription drug portfolio.

Nubeqa, following Xofigo, is another prostate cancer-related treatment drug launched by Bayer. As a novel androgen receptor inhibitor (ARi), Nubeqa exhibits higher AR affinity, and its unique structure provides stronger anti-tumor activity and enhanced safety. Clinical studies have shown that the prostate-specific antigen (PSA) response rate in treated patients reached as high as 71%. With its remarkable efficacy, Nubeqa’s sales performance has been on a steady rise since its launch, nearly doubling in 2023 to reach 869 million euros.

In the cardiovascular field, Kerendia, developed by Bayer, has demonstrated impressive market performance due to its therapeutic advantages in patients with early-stage chronic kidney disease and type 2 diabetes, achieving sales of 270 million euros (+152.3%) in 2023.

The launch of Aflibercept 8mg is an excellent example of Bayer's successful exploration in the full lifecycle management of mature products, which has also given Aflibercept a new lease on life. Data shows that the efficacy of Aflibercept 8mg is no less than the 2mg version and achieves a lower dosing frequency of once every five months. Within less than half a year of its launch, Aflibercept 8mg generated $166 million in revenue in the United States and is expected to become the standard therapy for the next generation of anti-VEGF treatments.

While continuously delivering commercial value through its mature products, Bayer also focuses on medical fields with significant unmet needs, providing patients with more treatment options. For example, elinzanetant, a drug for treating moderate to severe hot flashes related to menopause, is expected to be launched in 2025.

The menopausal period is a phase every woman will face. Statistics show that by 2030, the global population of menopausal women will increase to 1.2 billion, with approximately 47 million new cases each year. Many women experience various symptoms during the menopausal transition, with up to 48 different types, among which hot flashes, sleep disturbances, and mood changes are the most common. Although traditional hormone therapy is available on the market, many women instinctively resist using hormones for various reasons, ultimately missing the opportunity for treatment, which severely impairs their quality of life.

"Women's health has been integrated into Bayer's DNA," Stefan introduced, "For a century, Bayer has provided women with long-term and short-term contraceptive methods, as well as menopause management and therapies for gynecological diseases. Therefore,We have an obligation to bring innovation to the field of women's health.。”

In response to the disease burden in key细分fields of cardiovascular health, Bayer also looks forward to leveraging its extensive expertise to refresh patient treatment outcomes and experiences. Take transthyretin amyloid cardiomyopathy (ATTR-CM) as an example, a rare myocardial disease that, if not effectively controlled, can lead to heart failure and even fatal consequences.

BridgeBio's acoramidis is an orally administered potent ATTR-CM drug that has garnered global attention. It has met all clinical endpoints in Phase III clinical trials, and its marketing application to the EMA has been submitted. Recognizing the potential of this drug, Bayer decisively acted in March this year by acquiring the exclusive commercial rights for acoramidis in Europe, with returns expected in the near future.

“Secondly, it is to further supplement and advance the R&D pipeline, ensuring a continuous output of substantial innovative achievements.Stefan explained the second part of the strategy: "Bayer will focus on the quality and efficiency of projects. Currently, the pipeline is advancing very rapidly. Last year, we submitted eight new drug clinical trial applications. Additionally, four candidate drugs with first-in-class potential are expected to enter Phase II clinical trials by the end of 2024."

Of course, the ability to quickly prioritize from such a vast scale of innovative resources and simultaneously advance the clinical development of multiple products also reflects the high quality and efficiency of Bayer's decision-making level. The organizational restructuring that Stefan mentioned is the third part of the strategy.In order to further optimize organizational efficiency and production efficiency, we launched the new operating model Dynamic Shared Ownership (DSO) in 2023.Hope resources are truly allocated to areas that deserve high attention.”

"Turning medical breakthroughs into reality is more than just a statement—Bayer is taking concrete actions to implement this vision across the entire chain of new drug development," Stefan said directly.After the R&D strategy adjustment,Bayer has raised the standard for the application of science and technology, giving rise to a new path of innovation in the integration of science and technology. Its current R&D pipeline covers a wealth of new treatment modalities and approaches.

Specifically, to accelerate the transformation of healthcare into real-world applications, Bayer first introduces technologies such as artificial intelligence (AI) and proteomics to expedite drug discovery and development, addressing the challenge of undruggable targets. Secondly, it integrates platforms for cell and gene therapies, radiological treatments, and tumor immunology to build a strong reserve of innovative capabilities. Lastly, it improves early cancer diagnosis to provide precise treatment for patients as soon as possible.

The trend of AI-driven innovative drug development is sweeping across the pharmaceutical industry with an unstoppable wave. This is because AI can process massive datasets, uncover phenomena unobservable by humans, thereby transforming target discovery and drug design methods, greatly enhancing the efficiency and success rate of innovative drug research and development.

In mid-March this year, Bayer and Aignostics launched a strategic cooperation aimed at deeply integrating AI machine learning with biology, chemistry, and clinical data to create a new target identification platform. At the same time, AI will be used to connect baseline pathological data with clinical data, enabling the rational setup of patient groupings in clinical trials and accelerating the development of more precise cancer treatment solutions.

Bayer's recognition of AI technology has been intuitively reflected in its frequent investment activities. In addition to Aignostics, Bayer has previously reached partnerships with well-known AI drug discovery companies such as Cyclica, Exscientia, Genpact, Schrödinger, Sensyne, and Recursion.

Moreover, in order to breathe new life into undruggable targets, Bayer acquired Vividion, a company focused on the development of challenging targets, for a total price of 2 billion US dollars in 2021. "We have previously discovered some targets, but due to technical difficulties, we have been unable to realize their value."Now, with the support of new technologies, we can make full use of our existing assets."Stefan is full of anticipation for the successful development of undruggable targets."

Thanks to the boost from Vividion's chemical proteomics technology, those traditionally "undruggable" targets that once "lay" in the candidate library now have a greater possibility of successful development. According to Stefan, in the past six months, two projects in Vividion's pipeline have advanced to the clinical development stage: BAY 3605349, an activator targeting Keap1, and BAY 3630914, an inhibitor targeting STAT3.

Innovation exists at multiple levels. The more cutting-edge it is, the higher the risks, but with that come substantial rewards. By pushing forward so intensively in the research and development of novel targets and undruggable targets, Bayer has clearly stepped into a higher echelon of innovation, further unlocking more dimensions for the development of Bayer's precision oncology.We are working hard to expand the druggable target library for cancer's true weaknesses, building a highly differentiated, competitive, and innovative R&D pipeline to achieve long-term growth.”

At this media day, Bayer emphasized its vision of becoming a leading oncology company, while also identifying the development path: driving innovations with potential for breakthrough progress, with a focus on gastrointestinal cancers such as colorectal cancer and common cancers like prostate and lung cancer.

"In order to become a company with leading oncology business,Bayer has done a lot of work in reality, such as establishing a Research and Innovation Center in Boston."Stefan shared: 'Boston is arguably the global hub for oncology R&D, and our precision molecular oncology research team is based here.'"

Of course, in addition to focusing on the development of more effective and tolerable tumor drugs, correct and timely screening is also very important, and Bayer understands this well. In March this year, Bayer has reached a cooperation with Thermo Fisher Scientific to match its precision oncology product portfolio with next-generation sequencing-based companion diagnostic testing methods.

Cell and Gene Therapy (CGT) is another key area for Bayer in achieving medical breakthroughs. Stefan introduced "Leaps by Bayer," Bayer's investment arm that focuses on identifying groundbreaking therapies and technologies with the potential to cure or reverse the progression of diseases. BlueRock and AskBio are among its proud investment cases, carrying high expectations.

The in-development drugs BRT-DA01, a cell therapy, and AB-1002, a gene therapy, created by two subsidiaries, have demonstrated positive efficacy in early clinical trials for treating Parkinson’s disease and congestive heart failure, respectively. In addition, seven other CGT projects are at various clinical stages, all within the areas of highest medical need.

BlueRock Lab

Behind the continuous emergence of innovative projects is Bayer's sustained and high-level investment in original research and development. According to Bayer, it has cumulatively invested approximately 3.5 billion euros to build the CGT platform, covering high-demand disease areas such as the nervous system, cardiovascular, ophthalmology, and rare diseases.

However, Stefan noted that CGT products still need to overcome significant challenges from clinical research to market availability, such as scaling clinical trials, large-scale production, cost and quality control, and commercial implementation. To address this, Bayer has brought together its production, development, and commercialization teams to collaboratively explore ways to bring CGT to the market as soon as possible. At the same time, other partners, including distributors and healthcare service providers, are also considering how to ensure patient access.

In China, Bayer is collaborating with Peking University to facilitate the transformation of fundamental research findings in key areas such as CGT into new drug development, while accelerating the advancement of cutting-edge technology research across the drug development value chain. Additionally, Bayer is partnering with Shanghai Pharmaceuticals to introduce the Bayer Co.Lab co-creation platform to China, which will become an integral part of Bayer's global new drug incubation network, promoting frontier innovations in fields like CGT.

From early research, to possessing manufacturing capabilities and platforms, and ultimately achieving drug accessibility, Bayer is making countless efforts focused on the entire chain to accelerate the fulfillment of its promise to bring the benefits of CGT to patients. This will also endogenously generate an inexhaustible evolutionary momentum for Bayer's prescription drugs.

Finally, Stefan confidently stated,Bayer has a clear understanding of the focus of new drug development, and is able to develop more precise and "patient-friendly" drugs to improve the quality of life for patients worldwide.Meanwhile, Bayer, which has been in China for over 140 years, has already charted a clear path for its innovative development in the country.

Xiaolan Zhou, Global Executive Vice President of Bayer AG's Pharmaceuticals Division and President of Bayer China, and President of Bayer Greater ChinaIt has been mentioned on multiple public occasions that the company will accelerate the renewal and iteration of its product portfolio, focusing on key areas such as cancer, cardiovascular and cerebrovascular diseases, diabetes, and other chronic conditions.Providing more and better medicines to the Chinese market continuously。Will alsoDevelop research and development strategies for certain disease areas unique to China, in order to maximize support for currently unmet clinical needs and benefit more Chinese patients.

It can be seen that no matter how the prescription drug business evolves, encouraging innovation and benefiting patients have always been Bayer's core principles—focusing on high-demand areas that remain unmet, listening to patients' voices, and precisely addressing individualized needs and real-world application scenarios.

Copyright © 2024 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position.For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.