Bayer Invests €3.5 Billion to Build Cell and Gene Therapy Platforms, Advances Seven Clinical-Stage Programs

China Finance and Economics News, March 22nd, by reporter Du Ding. Yesterday, at the "Bayer Pharmaceuticals 2024 Global Media Day," Bayer showcased the latest progress in the transformation of its pharmaceuticals business.

"We have made significant progress in enhancing the value of our R&D pipeline, which shows that our adjusted R&D strategy is working," said Stefan Oelrich, member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division globally. Bayer continues to strengthen its influence in key therapeutic areas and has made remarkable progress in fully leveraging the potential of its marketed products.

　　Focus research efforts clearly on four core therapeutic areas

According to reports, Bayer has strengthened its innovative momentum, focusing its research on four core therapeutic areas (cardiovascular diseases, oncology, immunology, neurology, and rare diseases). At the same time, it has expanded its expertise through collaborations and acquisition platforms and improved the quality of its R&D pipeline with a well-planned product portfolio.

Bayer Advances R&D Pipeline in 2023, Submits Eight New Drug Clinical Trial Applications. Additionally, Four Drugs with First-in-Class Potential Expected to Enter Phase II Clinical Trials by End of 2024.

"In the past 24 months, we have been intensifying our R&D efforts and have made significant progress on the path to rebuilding a robust R&D pipeline," said Christian Rommel, member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development. Driven by a sense of urgency, Bayer will continue to achieve this goal, particularly by increasing new drug clinical trial applications, gaining more contributions from platform companies, and continuously seeking attractive new external partners or deals.

In early March, Bayer obtained the exclusive commercialization rights for acoramidis in Europe. Acoramidis is an oral, potent, and highly selective small molecule transthyretin stabilizer used to treat transthyretin amyloid cardiomyopathy (ATTR CM). In a Phase III clinical trial, acoramidis met all clinical endpoints. Its marketing authorization application has been submitted to the European Medicines Agency.

By advancing innovative therapies, Bayer is committed to increasing treatment options and raising the standard of care for women in menopause. Elinzanetant, a compound in Bayer's late-stage development pipeline, is the first non-hormonal treatment and a neurokinin-1,3 (NK-1,3) dual receptor antagonist, administered orally once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause. The pivotal Phase III clinical studies OASIS 1, 2, and 3 have recently achieved positive top-line results. Bayer will submit these positive data to relevant pharmaceutical regulatory authorities. Elinzanetant has blockbuster potential and is expected to be launched in 2025.

　　Phase II study in Parkinson's patients expected to launch this year

It is reported that Bayer and its subsidiaries BlueRock and AskBio are advancing a portfolio of preclinical and clinical-stage cell and gene therapies. These competitive cell and gene therapy programs include seven projects at various clinical stages, focusing on areas with the highest medical needs.

AskBio's gene therapy candidate AB-1002 has recently entered Phase II clinical trials to evaluate the efficacy and safety of a single administration of AB-1002 for the treatment of congestive heart failure, which affects approximately 26 million people worldwide. BlueRock Therapeutics released data on its investigational therapy bemdaneprocel (BRT-DA01) after 18 months of treatment in Parkinson’s disease patients. The Phase I clinical trial is still ongoing, with data showing positive trends. These findings also support plans to initiate a Phase II clinical study in 2024. Another gene therapy candidate is expected to enter Phase II studies in Parkinson’s disease patients later this year.

"Cell therapy and gene therapy are two of the fastest-growing and most competitive fields in modern medicine. Since 2020, Bayer has invested over 3.5 billion euros in building relevant technology platforms for the research and development of cell and gene therapies," said Christian Rommel, member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Global Research and Development. Bayer is excited about the significant progress made in its diverse and leading therapy platforms. "We believe that these early-stage projects will bring tangible benefits to patients in the future."

Moreover, with its innovative product portfolio, Bayer is expanding its influence in key therapeutic areas such as cardiovascular, oncology, women's health, radiology, and ophthalmology.