Bayer pharma applies breakthrough innovations to manage difficult-to-treat conditions

Bayer reveals major transformation in its pharmaceutical business with the use of breakthrough innovations aimed at helping patients with difficult-to-treat conditions. The transformation, disclosed at Bayer’s virtual Pharma Media Day in January 2021, involved more than 25 collaboration agreements and acquisitions with external partners and experts in key areas of cell and gene therapy, digital health and drug development.

“The biomedical and technological revolution that is transforming healthcare at an unprecedented pace is taking place now. Our company is at the forefront of the wave of innovation in cell and gene therapy as well as digital health,” said Stefan Oelrich, member of the Board of Management, Bayer AG, and president of Bayer’s Pharmaceuticals Division. “We are driving this transformation and growing our promising development portfolio together with our partners. Our joint goal is to bring breakthrough treatments to patients and make healthcare systems more sustainable in the mid- and long-term.”

In the area of cell and gene therapy, Bayer has established a new platform to drive and manage all activities while allowing for an innovation ecosystem for all partners, including BlueRock Therapeutics (BRT) and Asklepios BioPharmaceutical (AskBio), two companies fully owned by Bayer but independently operated. Bayer currently has seven advanced assets in different stages of clinical development focused on Pompe disease, Parkinson’s disease, haemophilia A, and congestive heart failure. US FDA recently approved BRT’s application for a phase I study on patients with advanced Parkinson’s disease, making it the first study on pluripotent stem cell-derived dopaminergic neurons in the US.

“Cell and gene therapies hold the promise to significantly impact patients’ lives by moving from treating symptoms to potentially curative approaches,” said Wolfram Carius, executive vice president and head of Cell and Gene Therapy at Bayer. “Together with our partners, we want to accelerate innovation at its source and along the whole value chain to ensure a fast translation of science into therapies for patients who have no time to wait.”

With regard to digital health, Bayer is developing Integrated Care concepts for individual support of patients via a personalized approach that deals with complex and interconnected health challenges. Bayer in collaboration with the digital health company InforMed Data Systems Inc. (IDS) are expanding the coverage of IDS’ existing diabetes management platform (known as One Drop) to include the needs of patients in the therapeutic areas of cardiovascular disease (CVD), women’s health and oncology. The first two modules will be available within a year.

“By focusing on the individual patient, not their disease, Integrated Care is the path to truly inclusive and personalized healthcare,” said Jeanne Kehren, senior vice president of Digital and Commercial Innovation, and member of the Pharmaceuticals Executive Committee of Bayer AG. “We are determined to make Integrated Care solutions a major pillar of our company’s pharmaceutical business. Building on our expertise in the pharmaceutical sector, we can bridge the gap between tech and healthcare. In the next 10 years, we expect digital health offerings to significantly contribute to our revenues.”

Promising pipeline for various chronic conditions
While more than 50 projects focusing on CVD, oncology and women’s health are in the pipeline, Bayer spotlighted two promising programmes: Factor XI (FXI) inhibitors, a new class of anticoagulants, and P2X3 antagonists, which have a range of indications.

FXI inhibitors may confer protection against thromboembolic events without increasing bleeding risk. FXI inhibitors include a small molecule oral FXIa-inhibitor that is undergoing a phase IIb trial, an anti-FXIa antibody, and a FXI-ligand-conjugated antisense oligonucleotide, which Bayer is developing under exclusive license from Ionis Pharmaceuticals. The anti-FXIa antibody and a FXI-ligand-conjugated antisense oligonucleotide are in phase II trials involving patients with end-stage kidney disease.

With regard to P2X3 antagonists, Bayer is working with Evotec, a Germany-based drug discovery and development company, and has started phase IIa clinical trials for overactive bladder and diabetic neuropathic pain, and phase IIb clinical trials for refractory and/or unexplained chronic cough, with a trial in endometriosis soon to follow.

The P2X3 antagonists being trialled could potentially offer a new treatment approach for multiple conditions and improve the quality of life of these patients. This is a result of Bayer’s development strategy where a novel path in research and development follows multiple possible indications early on and in parallel in the clinic.

“Our research in the fields of factor XI inhibitors and P2X3 antagonists are just two promising examples of mid-stage programmes that demonstrate our ongoing commitment to building and advancing a strong development pipeline,” said Oelrich. “Positioning Bayer as a leader in the highly dynamic space of healthcare innovation, we will continue to lead the field in bringing new solutions to patients who need them.”

Yet another investigational first-in-class treatment, finerenone is indicated for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Vericiguat, jointly developed with MSD, for the treatment of patients with chronic heart failure and reduced ejection fraction (HFrEF) was approved in the US in January 2021 and is pending approval in multiple countries.

In the area of oncology, highlighted products include darolutamide for patients with nonmetastatic castration-resistant prostate cancer and at high risk of developing metastatic disease, and larotrectinib, a first-in-class precision oncology treatment for patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase gene fusion. Darolutamide, jointly developed with Orion Corporation, has been approved in the US, the European Union (EU), Brazil, Canada, and Japan, while larotrectinib has been approved in more than 40 countries, including the US and EU.

In the area of women’s health, Bayer recently acquired KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, which is developing BAY-342 (formerly NT-814) for the treatment of vasomotor symptoms such as hot flashes and night sweats during menopause. BAY-342, a first-in-class, nonhormonal, once-daily, oral neurokinin-1,3 receptor antagonist, will undergo phase III clinical trial in 2021.