Boehringer Ingelheim R&D pushes to transcend disease boundaries

Boehringer IngelheimFamily-owned pharmaceutical company Boehringer Ingelheim has presented its latest pipeline updates at a Research & Development press conference entitled 'Transcending Disease Boundaries', at its global headquarters in Ingelheim, Germany. The company's R&D strategy and current pipeline has the potential to deliver 15 new medicines for approval by 2025 (probability adjusted). With a high percentage of first-in-class and breakthrough potential drug candidates, Boehringer Ingelheim continues the successful implementation of its R&D strategy.

Boehringer Ingelheim is committing more than €20 billion to Research & Development for human pharmaceuticals by 2025. In the past four years, the company received 14 regulatory approvals in several new indications, including four new molecular entities and four breakthrough designations by the US Food and Drug Administration.

"The most ambitious goal for researchers is to achieve a medical breakthrough for patients from our over 80 clinical and pre-clinical projects. Some 65% of our drug pipeline candidates already have breakthrough and/or first-in-class potential, and we aim for even more" said Dr Michel Pairet, Member of the Board of Managing Directors, responsible for Boehringer Ingelheim’s Innovation Unit, "Transcending disease boundaries is about looking at R&D with fresh eyes."

To fulfil such aspirations, Boehringer Ingelheim embraces risks to dig deep into the mechanisms of diseases, to integrate the latest scientific and technological advances, and to work with the best partners to discover and deliver new medicines.

"Our worldwide team of 8,000 scientists, medical doctors and other contributors is truly motivated by our pipeline, its progress and what this could mean for patients." commented Dr Christopher Corsico, Chief Medical Officer, Boehringer Ingelheim. "With ongoing work on a first-in-class inhibitor targeting inflammatory skin and bowel diseases, transformative oncology candidates, a promising schizophrenia prevention strategy and major indications for two of our blockbusters, Ofev® in lung fibrosis and Jardiance® in chronic kidney disease and chronic heart failure, we look forward to bringing years of health and improved quality of life to millions of people."

To support and complement its own R&D, Boehringer Ingelheim is increasing the emphasis on external collaborations and expanding the community of innovation partners. The company currently works with over 70 innovative partners in universities, scientific institutions and biotech companies.

"Our long-lasting relationships with our partners are built on respect, empathy, trust and passion - values which foster an environment where synergies are realized, resulting in the potential for faster and better results." said Dr Michel Pairet. "Our long-term, unwavering commitment to researching and developing new medicines will bring the transformative medicines that patients need."

Highlights of Latest Boehringer Ingelheim Pipeline Progress

Immunology

In Immunology Boehringer Ingelheim's IL-36 receptor inhibitor has the potential to transform the standard-of-care for patients with immune-mediated diseases. BI 655130, a new biological entity and first-in-class IL-36 receptor antibody, has shown strong efficacy in early clinical testing with a single dose in patients affected by Generalized Pustular Psoriasis. These results support a broad potential in multiple inflammatory diseases.

Trials are underway in further immune-mediated diseases of the skin and intestine including Palmo-Plantar Pustulosis, Ulcerative Colitis, Crohn’s Disease, and other chronic inflammatory conditions.

Oncology

Boehringer Ingelheim is exploring therapies that target tumour cells directly in pathways so far ‘undrugged’. In Immune Oncology, the research teams are “turning up the heat on cancer” with therapies that activate the abilities of the patient’s own immune system and by bringing together smart and highly promising combinations of both types of therapies.

We are advancing combinations of immune-cell targeted therapies e.g. cancer vaccines, oncolytic viruses and T-cell engagers, as well as immunogenic cell death inducers such as our SMAC mimetic with BI 754091, a PD-1 checkpoint inhibitor.

In cancer cell directed projects, Boehringer Ingelheim’s oncology research portfolio includes more than 10 clinical-stage assets. We are working on new drug candidates in pathways such as KRAS, WNT and p53, and will move towards clinical trials for many of these in the next 12-24 months.

Central Nervous System

In CNS, Boehringer Ingelheim has expanded its PDE9 inhibition research programs to the prevention of relapse in schizophrenia and also in the prevention of first episode psychosis. Boehringer Ingelheim’s research approach in CNS is taking a courageous “against the current” approach. The focus is on understanding how underlying malfunctions in brain circuitry manifest in specific symptoms and traits of mental illnesses. This is key to going beyond the current disease classifications which do not reflect the underlying disease mechanisms. Boehringer Ingelheim investigates a range of mental disorders such as schizophrenia, Alzheimer's disease and depression.

Fibrosis (Respiratory and Cardiometabolic Diseases)

Based on the pathophysiological and mechanistic parallels of fibrotic diseases, Boehringer Ingelheim is investigating its compound nintedanib in a wide spectrum of fibrosing Interstitial Lung Diseases (ILDs).

Two Phase III clinical trials are exploring the efficacy and safety of nintedanib (OFEV®) in Systemic Sclerosis ILD (SSc-ILD) and Progressive Fibrosing ILD (PF-ILD). The SENSCIS study has completed enrolment and may end in December 2018. The INBUILD study is likely to complete enrolment in Q2 2018.

In NASH, another fibrotic disease affecting the liver, Boehringer Ingelheim applies its deep understanding of the metabolic, inflammatory and fibrotic components of the disease and is investigating a frontrunner compound, an AOC3 inhibitor, in a Phase II clinical trial.

Cardiometabolic Diseases

In Cardiometabolic diseases, Boehringer Ingelheim is building on the strength of the results of the EMPA-REG OUTCOME® trial to explore the potential benefits of empagliflozin (JARDIANCE®)(1) beyond diabetes. Boehringer Ingelheim is investigating the potential of empagliflozin to protect patients with and without diabetes from the risk of chronic kidney disease and chronic heart failure.

Phase III studies are underway investigating the effects of empagliflozin in patients with Chronic Kidney Disease (CKD) and in patients with Chronic Heart Failure (CHF). The EMPA-KIDNEY and EMPEROR HEART FAILURE studies are expected to read out between 2019 and 2020.

About Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success, rather than short-term profit. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

1. Jardiance® is jointly marketed by Boehringer Ingelheim and Eli Lilly and Company.

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