Boehringer Ingelheim: Pioneering a Brave New World in Healthcare

Boehringer Ingelheim: Pioneering a Brave New World in Healthcare

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Wolfgang Baiker, U.S. President & CEO, Boehringer IngelheimWolfgang Baiker, U.S. President & CEO The year is 1885. Albert Boehringer is hard at work in his small tartar factory in Ingelheim, Germany producing tartaric acid—a primary component which is used in food substances such as baking soda. A few years down the road, Boehringer strikes gold on discovering that lactic acid can be mass-produced by means of bacteria. At that time there wasn’t much research done in this field and concurrently there was a booming demand for lactic acid in industries such as dyeing, leather, textile, and food. The rest, as they say, is history, and in a short time span, this one man venture evolved into a pioneer in large-scale biotech production.

"The objectives and beliefs of Boehringer Ingelheim can be summed up in a single phrase: Value through Innovation"

Today, after 135 years that Boehringer laid the cornerstone of his company, the legacy still continues just that it’s grown in mammoth proportions. With 145 affiliates globally and over 50,000 employees, Boehringer Ingelheim, a research-driven pharmaceutical juggernaut is a brand beyond par. The company is deeply committed to the discovery, development, and manufacture of new medications with high therapeutic value and also heavily invested in animal healthcare. Their wide range of preventative animal healthcare products is among the most highly regarded solutions in the industry. Headquartered in Germany, Boehringer’s footprint is spread across all continents with three subsidiaries in the U.S. alone. The U.S. division is currently headed by Wolfgang Baiker, President and CEO who has been associated with the company for three decades and has served in a number of senior leadership roles at Boehringer. With Baiker’s expertise and Boehringer’s vision, the company’s contribution to the pharmaceutical world as a contract manufacturing organization (CMO) is truly matchless.

Championing Modern-Day Healthcare

Generating 72 percent of total net sales, human pharmaceuticals is the most important pillar of Boehringer Ingelheim’s business. Their prescription medication products such as Aggrenox, Mirapex, and Pradaxa meet the highest quality standards, and their respiratory medicine SPIRIVA was yet again the best-selling preparation in 2018. Boehringer’s top-of-the-line medical innovations and research and development initiatives are creating breakthroughs in the fields of cardiovascular disease, oncology, CNS, and immunology in the market today. To fulfill such aspirations, Boehringer Ingelheim digs deep into the mechanisms of diseases, integrates the latest scientific and technological innovations into their solutions, and works with the best partners to discover and deliver new medicines.

The company is deeply committed to the discovery, development, and manufacture of new medications with high therapeutic value

For example, in the cardiovascular field, the company has advanced state-of-the-art treatments that improve the care of patients suffering from irregular heartbeats (atrial fibrillation), stroke, blood clots in deep veins or lungs (deep vein thrombosis or pulmonary embolism), high blood pressure (hypertension) or heart attack (myocardial infarction). Similarly, Boehringer is bringing new hope to patients suffering from lung and gastrointestinal cancers. Their unique pipeline of cancer cell directed agents, immuno oncology therapies, and intelligent combination approaches to help combat this lethal disease has managed to save several lives. Recently, the company acquired ICD Therapeutics to further enhance oncology R&D and the merger has the potential to eliminate one of the hurdles that cancer biologics face—getting access to targets inside tumor cells.

When it comes to respiratory-related diseases, the company has over 95 years of heritage and experience in this space, having launched several revolutionary treatments for conditions such as asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and lung cancer. Another field where Boehringer has made noteworthy progress is psychiatry where it extends effective treatment approaches for underserved illnesses such as schizophrenia or Alzheimer’s. At present, the company has a range of different compounds in development that address cognitive impairment and depression, some of which are in the advanced clinical phases. Through it all, the company’s main area of focus is to drive a “beyond the pill” approach.

Pioneering and Promoting Well-Being

In addition to recognizing the importance of human well-being, Boehringer stands out in the industry for their contribution to animal health as well. Boehringer Ingelheim is the second largest animal healthcare business in the world, with a presence in more than 150 markets and a focus on prevention. The company brings to bear a large portfolio of advanced, preventive healthcare products, tools and services, to support customers in taking care of the health of their animals. This includes the development of vaccines, parasiticides, and pharmaceuticals that limit pain, slow down disease progression, and protect animals against diseases. One of their latest feats is the launch of Arti-Cell® Forte, the first-ever registered stem cell-based veterinary medicine. Cherishing the bond that people and animals share, today more than 3,000 people are powering Boehringer’s U.S. animal-health business unit.

The third important segment for Boehringer is their biopharmaceuticals division. The company is the world-leading contract manufacturer of biopharmaceuticals, using cell cultures and microorganisms.
They are dedicated to improving the lives of patients by exploring innovative ways for biosimilars. As the name suggests, a biosimilar is a nearly identical version of an approved biologic medicine but not an exact copy of its reference product. However, it works in the same way as the reference biologic, and therefore patients can expect no clinical differences in the therapeutic effect. But biosimilars take up to eight years to develop and they are complex and costly to characterize, requiring more extensive data than generics. All of Boehringer’s biosimilars are produced using a sophisticated, highly technical, multistep process. They are also put through rigorous testing and reviewed by the FDA. The biosimilar development process is inherently complex and requires a high degree of technical innovation and regulatory expertise. To date, Boehringer has manufactured complex products and developed more than 25 biologics for global markets including monoclonal antibodies in oncology, immunology, and other targeted medicines for a broad range of therapeutic areas.

Transcending Disease Boundaries

Since clinical trials are an essential part of the development of new medicines, Boehringer conducts rigorous investigations and in the last decade has sponsored close to 1,300 clinical studies involving more than half a million patients. Carefully conducted clinical trials are the fastest, safest, and most reliable way to find treatments that work for different patient populations. Boehringer Ingelheim is committed to the inclusion of diverse populations and its clinical trials are studied in a broad range of patients for whom the treatment is intended—this includes differences in age, race, ethnicity, sex, and other characteristics. To stay at the leading edge of the CMO market, the company partners with several industry bigwigs such as Dicerna Pharmaceuticals, AbeXXa Biologics, and Hydra Biosciences. As part of the Boehringer Ingelheim global family of innovation, Boehringer helps its partners to develop and grow, joining forces in a ‘meeting of minds’ to create new journeys of discovery.

The objectives and beliefs of Boehringer Ingelheim can be summed up in a single phrase: Value through Innovation. This vision has helped the pharmaceutical giant build on its strengths and distinctive offerings. Going forward, agility is going to be an explicit component in all of Boehringer’s endeavors. This refers to scrum methodology in project management or design thinking and an attitude that allows employees and thus the organization to quickly perceive changes in the environment, analyze them, and react quickly. Also on the drawing board are plans to develop novel poly-agonist peptides to treat obesity. This headway will be made in partnership with Gubra, a privately-held biotech company with pre-clinical contract research as their primary area of business. By bringing together Gubra’s established expertise in the design, synthesis, pharmaceutical characterization and in vivo testing of therapeutic peptides with Boehringer Ingelheim’s expertise in the research and development of innovative medicines in cardiometabolic diseases, the medical world can expect a much needed new treatment options for obesity patients. On an ending note, the CEO says, “I look forward to our continued scientific advancements and leading our diverse and dynamic U.S. organization.”
- Stacey Smith
    June 25, 2019

Boehringer Ingelheim News

Boehringer Ingelheim and OSE Immunotherapeutics Announce Dosing Of the First Patient in a Phase 1 Trial of SIRPα Antagonist Monoclonal Antibody, BI 765063, in Patients with Advanced Solid Tumors

Ingelheim, Germany and Nantes, France – June 17, 2019, 6:00 p.m. CET - Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today announce that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors. The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor.

“We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes for patients with difficult-to-treat cancers,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim.

“We are excited to begin first-in-human testing with this novel SIRPα-targeting compound, which we believe has first-in-class potential in the treatment of solid tumors,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. “This marks one of many anticipated milestones in the collaboration agreement with our partner Boehringer Ingelheim, and we look forward to advancing rapidly this potentially transformative treatment through the clinic. Milestones such as this one for the novel compounds our R&D teams develop have provided OSE with a stable financial base to grow steadily our first-in-class immuno-oncology pipeline.”

The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. Under the terms of the collaboration and license agreement, the clinical trial authorization obtained in March 2019 and dosing of the first patient in this Phase 1 trial triggers milestone payments of a total of €15 million to OSE Immunotherapeutics from Boehringer Ingelheim. This trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumours.

ABOUT BI 765063 (formerly OSE-172)

BI 765063 is a monoclonal antibody antagonist of the key myeloid cell checkpoint inhibitor SIRPα. BI 765063 prevents the SIRPα ligand CD47, from binding to SIRPα thereby preventing cellular signalling that can reduce the anti-tumorigenic properties of myeloid cells such as macrophages and dendritic cells. In March 2019, OSE Immunotherapeutics received Clinical Trial Authorization for a Phase 1 study by two health agencies (France and Belgium) to evaluate BI 765063 in patients with advanced solid tumors. The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, originally signed in April 2018.