The Board of Managing Directors
2023 was a year in which we strongly progressed our pipeline. The number of diseases we address, and the breadth of our assets underscore our commitment to research. It is also testament to our ambition to pioneer breakthrough treatments in areas of high unmet patient need, such as mental health, oncology, fibrosis, and cardiovascular-renal-metabolic diseases.
Our research efforts in mental health continued to evolve, focusing on treatments that can address the biology of the brain more precisely. Phase-III-trials for our most-advanced asset, iclepertin, are progressing well. Iclepertin is planned to be launched in 2026 for the treatment of patients with cognitive impairment associated with schizophrenia (CIAS). Our investigational prescription digital therapeutic CT-155, designed to treat negative symptoms of schizophrenia, which we develop in collaboration with Click Therapeutics, moved towards a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
We also received a U.S. FDA Breakthrough Therapy Designation for nerandomilast, a phosphodiesterase 4B (PDE4B) inhibitor for pulmonary fibrosis. We will read out Phase III of the FIBRONEER® Trials towards the end of this year. The Phase II data has shown the potential to stabilize disease-related lung function decline in patients with idiopathic pulmonary fibrosis.
Michael Schmelmer
Paola Casarosa
Frank Hübler
Hubertus von Baumbach
Carinne Brouillon
Shashank Deshpande
In oncology, our MDM2-p53 antagonist brigimadlin advanced into the pivotal trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of two additional investigational therapies from our oncology pipeline has been accelerated, based upon positive early clinical data.
Jardiance® continued its strong momentum and received regulatory approval in Europe and the United States for treatment of chronic kidney disease, making it potentially available to 850 million people. In addition to existing indications in type 2 diabetes and heart failure, Jardiance® can help manage cardiovascular-renal-metabolic conditions of more than 1 billion people.
Our Animal Health business received the approval of the U.S. FDA and the European Commission for SENVELGO®, our revolutionary new oral treatment for cats with diabetes. And we launched NexGard® PLUS, an oral combination parasite protection for dogs.
In 2023, we significantly increased the number of human patients we reached to 61 million. To be able to do so we invested 1.2 billion Euro into our global infrastructure and production network, as well as 5.8 billion Euro in R&D across both businesses in 2023, representing an increase of 14%.
These advancements are more than just milestones; they are the result of our long-term focus on innovation, as expressed in “Life Forward”. Our passion for innovation lives in the hearts and actions of our dedicated employees and the many partners, who work tirelessly to bring our purpose to life. We express our deepest appreciation to all of them, for their commitment, their contributions, and their shared passion.
signed by
Hubertus von Baumbach
Michael Schmelmer
Carinne Knoche-Brouillon
Dr. Paola Casarosa
Shashank Deshpande
Frank Hübler