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Berlin, 10 January 2023 At the 41st Annual MeetingSt Bayer AG, at the J.P. Morgan Healthcare Conference in San Francisco announced that it will increase its peak sales forecasts for key growth drivers within its pharmaceutical portfolio to more than twelve billion euros. The company is tracking potential blockbuster drug breakthroughs ahead of schedule and has targeted investments in Research and Development to replenish its pipeline. This improves the outlook.
The potential for Nubeqa(tm), or darolutamide, to be the standard in care for patients with prostate cancer from its early to late stages has been projected at more than three-billion euros. Based on strong data, Nubeqa(tm) has increased its market share to more than 30 percent for non-metastatic prostate cancer (nmCRPC). It has also been granted US label extension for patients with metastatic hormone sensitive prostate cancer (mHSPC).
ARASENS Study. Further approvals in Europe, Japan and China for the treatment mHSPC will drive growth. Market share gains are also expected to continue. The Phase III Phase III clinical trials (ARANOTE, ARASEC) of darolutamide are ongoing. They aim to expand its usage by providing treatment options for metastatic hormonal-sensitive patients without the need for chemotherapies. The use of Darolutamide in biochemical relapse or adjuvant settings are also under investigation.
Kerendia ™(finerenone) is a non-steroidal mineralocorticoid antagonist that represents a unique treatment option for patients suffering from cardio-renal disease. It could be worth more than three trillion euros. The therapeutic option is a leader in US launch, surpassing benchmark launches in cardiovascular. This strong launch momentum is expected to continue, driven by its robust position on top of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, its broad utility and relevance across general practitioners, endocrinologists, nephrologists and cardiologists as well as growing patient numbers and longer treatment durations in the US. Future reimbursement approvals for non-US territories will be a further boost to growth, as well as additional guideline inclusions.
The oral factor XIa inhibitor (FXIa), asundexian, is predicted to make a significant impact on growth. Asundexian is expected to be a distinct choice for the prevention and treatment of thrombosis as well as ischemic strokes. Around 40% of patients who are eligible for asundexian do not receive direct anticoagulants. Asundexian, a once-daily oral FXIa inhibitor that is first in class, can prevent the formation of clots and stop thrombosis. It also preserves the body’s ability for responding to bleeding events. Bayer’s Phase II, comprehensive study program PACIFIC found that asundexian could reduce the chance of thrombotic and bleeding events. These promising clinical results have led to the launch of the groundbreaking Phase III program OCEANIC for atrial fibrillation, non-cardioembolic stroke and OCEANIC Phase III. This program is being used by nearly 30,000 people worldwide.
Elinzanetant is an innovative small molecule that’s non-hormonal and has the potential to be a blockbuster. It was developed to treat vasomotor symptoms in menopause. Hot flashes, also known as vasomotor symptoms, are reported by nearly 80 percent of women during menopause. These symptoms can have a negative impact on sleep quality, mood, and your overall health. A third of all women experience severe symptoms that can persist for up to ten years after their last period. There are only a few treatment options for vasomotor symptoms. In the United States, 16 million women suffer each year. Contraindications and personal preferences may prevent many women from pursuing hormone therapy as their standard of care. Instead, Elinzanetant is an oral, first-in-class and non-hormonal drug contender. It inhibits both the neurokinin-1, 3 receptors, and potentially reduces hyperactivity of the neuronal circuits involved in the regulation of thermoregulation (kispeptin, neurokinin A, and dynorphin). The drug candidate showed a significant improvement in vasomotor symptoms during Phase II and was well tolerated. The first results of the Phase III OASIS program will be available in the second quarter 2023.
Stefan Oelrich is President of Bayer’s Pharmaceuticals Division and Member of the Board of Management at Bayer AG. “The successful launches of Nubeqa ™, Kerendia ™ reflect our commitment towards bringing innovative medicines into patients. With the future growth potential increasing significantly over the next few years, we have a lot of sales growth potential,” said Oelrich. Positive study results from our gene and cell therapy platforms have a potential upside, which is difficult to quantify but could reach the multi-billion euro range.
Bayer is pursuing long-term sustainable growth by renewing its portfolio, as well as a continuous shift in resources including the establishment of an American presence. The acquisition of platform companies BlueRock Therapeutics, Asklepios Biopharmaceutical and Vividion Therapeutics are a third strategic component to increase sales growth. They have exhibited industry-leading scientific innovations and successfully diversified and strengthened Bayer’s portfolio.
BlueRock is an innovator in stem cell-engineered cell therapy and has a wide range of therapies to treat patients suffering from neurological, immunological and cardiovascular diseases. The company’s latest program, BRT-DA01, is currently being used to treat Parkinson’s disease. This progressive neurodegenerative disorder results from nerve cell damage. The program is made up of pluripotent stem cells-derived dopaminergic neuronal neurons. These are then implanted in the brain to target the root cause. The Parkinson’s Foundation estimates that more than 10,000,000 people suffer from Parkinson’s Disease worldwide. BRT-DA01 is now enrolled in Phase I of the clinical trial. Data will be available by the end of 2023.
AskBio operates a leading AAV-based gene therapy platform. It has demonstrated its applicability and excellent manufacturing capabilities. AskBio is driving Bayer’s development of novel investigational gene therapies across multiple indications, including neuromuscular and central nervous system. The clinic is currently working on the most advanced treatments for Parkinson’s, Pompe and congestive cardiac failure. Patients are being enrolled in first-in-human trials for gene therapy programs to treat Huntington’s Disease and Multiple Systems Atrophy.
Bayer will greatly benefit from the strategic partnership with Mammoth Biosciences, Inc., which uses its pioneering gene-editing technology both as an enabling technology and as a standalone therapeutic modality. Bayer will be able to unlock the potential of its gene and cell therapy strategies by combining Mammoth’s innovative CRISPR system with Bayer’s gene augmentation systems and its induced pluripent stem cell platforms.
Bayer invested heavily in Vividion, its industry-leading chemoproteomics platform and Vividion to increase its small molecule drug discovery and precision therapeutics pipeline. Vividion’s groundbreaking technology is able to unlock the potential of high-value, previously untapped targets in the human disease proteome. Combining Bayer’s decades-long expertise in small molecule therapy development and marketing, this technology allows for unprecedented innovation to benefit patients from a variety of diseases. In 2023, the first two programs that address high-profile cancer targets will be clinical Investigational New Drug Applications (IND).
Christian Rommel (Head of Research and Development, Bayer Pharmaceuticals) stated that the transformation was well under way. New therapeutic targets and modalities have been contributing more to our early-stage development portfolio and are already making up a significant portion of our annual R&D resources. This reflects their importance in our new strategy. We expect several milestones in 2023 for our late and early-stage pipelines that will enable us to continue advancing medical innovation for those who need it.
Bayer has made a significant advancement in its R&D capability since 2018. This is evident in the new, detailed presentation of their R&D pipeline. Here.
Bayer is committed to accelerating innovation via external channels as part of its strategy. Bayer is a trusted partner that drives science and data. Bayer also believes in transparency and openness at all stages of collaboration. In recent years Bayer has demonstrated great flexibility when it comes to collaborative arrangements, such as the arm’s-length partnering model.
Marianne De Backer (Head of Strategy, Business Development & Licensing/Open Innovation) said that “we are focused on a holistic method of investing in new technology platforms, pursuing external growth through innovation.” She is also a member of the Executive committee Bayer Pharmaceuticals. These partnerships are a reflection of our emphasis on collaboration rather than integration and help preserve the partner’s entrepreneurial culture. We have seen accelerated drug development results by maintaining our independence using an operational model that is completely independent.
Bayer continues to explore new ways to engage with the biotech community. Its arm’s-length partnering model attracts external innovators, and contributes to Bayer’s success in breakthrough innovation.
The company has made more than 7 billion dollars in acquisitions of biotech companies and managed 60 ongoing strategic alliances. The company has established a strong local presence in major markets worldwide, including San Francisco, Boston, San Francisco and Research Triangle Park – North Carolina.
Bayer continues to prioritize external collaboration to complement its in-house expertise and expand its history of success in developing innovative therapies. This is in order to meet high unmet medical need. Bayer’s open-ended operating model, especially for therapeutic areas that aren’t yet central to the company like neurodegenerative disease, will evolve. Bayer shares the common goal of bringing personalized medicine closer to patients. These therapies are unique and require that existing regulatory frameworks be redesigned. Every therapy is unique and requires innovation, expertise, and a regulatory pathway that no one person can follow.
Bayer
Bayer is an international enterprise that has core competences in life sciences such as nutrition and health care. Bayer’s products and services help the world thrive and support efforts to address the challenges of a rapidly growing global population. Bayer is determined to drive sustainable development, and make a positive difference through its businesses. The Group also aims to grow its earnings and add value by innovation and growth. Bayer stands for quality, trust and reliability around the globe. The Group had around 100,000 employees and a total sales volume of 44.1 million euros in fiscal 2021. Before special items, R&D expenditures amounted to 5.9 billion Euros. Go to www.bayer.com.
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Forward-looking statements
Forward-looking statements may be made in this release based upon current forecasts and assumptions of Bayer management. There are many unknown and potential risks and uncertainties that could cause material deviations between actual results and financial development and performance. This includes the factors discussed in Bayer’s public reports, which can be found on Bayer’s website. www.bayer.com. These forward-looking statements are not subject to any liability by the company. They can be used to help you plan for future developments or events.