First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development



INGELHEIM, Germany – (COMMERCIAL THREAD) – In the first half of 2021, Boehringer Ingelheim supplied more humans and animals around the world with innovative medicines than ever before. The company’s success is based on its rich R&D portfolio focused on diseases with high unmet medical need. Human Pharma’s R&D pipeline includes more than 60 new substances and around 100 clinical and preclinical projects. This pipeline has the potential to deliver up to 15 drugs for approval by 2025.

In July, Boehringer Ingelheim announced a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE®). Over 60 million patients worldwide suffer from this disease, approx. half of them with heart failure with preserved ejection fraction (HFpEF). Heart failure with preserved left ventricular ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with ICFpEF. If approved, Boehringer Ingelheim’s empagliflozin would become the first and only clinically proven treatment to improve outcomes across the spectrum of heart failure patients, regardless of ejection fraction. In June, the European Commission granted the marketing authorization for JARDIANCE® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

“Despite all the medical advancements made in recent decades, there are still many diseases for which there is not yet adequate treatment available. That is why at Boehringer Ingelheim we focus on areas where the need for medical innovation is high ”, said Hubertus von Baumbach, Chairman of the Board of Directors. “Our strong R&D pipeline made further breakthroughs in the first half of 2021. These medical successes have the potential to improve the lives of millions of patients around the world.

Progress in the Mental Health Pipeline

Boehringer Ingelheim has also made progress in the area of ​​neuropsychiatric disorders, including two ongoing Phase II trials. At the end of May, Boehringer Ingelheim announced that the United States Food and Drug Administration (FDA) had granted the Breakthrough Therapy Designation (BTD) to BI 425809, a key part of the company’s mental health research program, for the treatment of cognitive disorders associated with Schizophrenia (CIAS). Boehringer Ingelheim also announced the planned launch of the innovative CONNEX phase III clinical trial program evaluating the safety and efficacy of BI 425809, a novel glycine-1 transporter (GlyT1) inhibitor, to improve cognition in patients. adults with schizophrenia.

The company has complemented its own research and development capabilities and its medical pipeline with other high-level partnerships, particularly in the areas of quantum computing and data science. In June, Boehringer Ingelheim became a founding member of the Quantum Technology and Application Consortium (QUTAC), which brings together ten of Germany’s leading companies exploring industrial applications for quantum computing. Quantum computing holds enormous potential for pharmaceutical research and development, especially for early research processes in which Boehringer Ingelheim has a high level of expertise.

Boehringer Ingelheim also remains committed to researching potential therapies against the SARS-CoV-2 virus. In July, the company announced that it would focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, known as acute respiratory distress syndrome ( ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the phase 2/3 study of TRISTARDS, after the completion of the phase 2b portion of the study including 62 patients. . The BI 767551 SARS-CoV-2 neutralizing antibody development program will be discontinued, as the current state of the pandemic makes it difficult to continue clinical development of this antibody and make it available to patients within a reasonable timeframe to contribute to the fight against COVID. -19 pandemic.

Solid commercial performance despite the persistence of the effects of the pandemic

After a successful 2020 financial year, Boehringer Ingelheim continued its positive trend in the first half of 2021. In the first six months, the company generated net sales of 9.8 billion euros, up 5.8 billion euros. % (over one year and corrected for currency effects). The three business areas (human pharma, animal health, biopharmaceutical contract manufacturing) contributed to the growth in net sales.

“With our employees, we achieved strong financial results in the first half of the year, even as the COVID-19 pandemic continues to have an impact, ”said Michael Schmelmer, board member in charge of finance and corporate functions. group. . “We are seeing that in many countries, people are avoiding seeing their doctor because of COVID-19, even though they are in urgent need of diagnosis and treatment. This non-treatment poses a serious medical problem, which we must take into account even more in the fight against the pandemic. ”

Human pharma: JARDIANCE® and OFEV® growth drivers

In Human Pharma, Boehringer Ingelheim achieved net sales of 7.1 billion euros in the first half of the year, equal to the high level of last year. Adjusted for currency effects, net sales increased 5% year-on-year.

Human Pharma’s growth continues to be driven by SGLT-2 inhibitor JARDIANCE® and OFEV respiratory medicine®. Revenue generated by JARDIANCE® increased by 17.2% (year-on-year and adjusted for currency effects) to 1.4 billion euros. Boehringer Ingelheim co-developed and markets JARDIANCE® with Eli Lilly and Company. OFEV respiratory product net sales® increased by 28.9% (year-on-year and adjusted for currency effects) and amounted to 1.2 billion euros. OFEV® is approved for the treatment of people living with Idiopathic Pulmonary Fibrosis (IPF) in over 80 countries, for DLI associated with systemic sclerosis (SSc-ILD) in over 70 countries, and for other interstitial lung diseases chronic fibrosing with a progressive phenotype (PF-ILD) in more than 60 countries.

Animal health performs well in the companion animal and livestock sector

Boehringer Ingelheim has a comprehensive portfolio of R&D projects to develop innovative solutions for pet and livestock health. One example is the clinical trial of velagliflozin, an SGLT2 inhibitor with therapeutic potential to treat diabetes in cats. Velagliflozin was developed primarily for use in the treatment of type 2 diabetes in humans by lowering blood sugar and now offers an opportunity for application in animal health. To complement its own R&D portfolio, Boehringer Ingelheim has entered into promising new partnerships in the field of animal health. In the first half of 2021, this included partnerships with PetMedix to develop novel and transformative antibody therapies for companion animals, and with Lifebit Biotech to detect and early report global infectious disease outbreaks using intelligence. artificial.

In the first half of 2021, Boehringer Ingelheim achieved strong net sales of around 2.3 billion euros in the Animal Health business area. Adjusted for currency effects, year-over-year sales increased 9.6% in this very competitive market.

The antiparasitic drug NEXGARD® for dogs remained the best-selling product with net sales up 16.4% (year-on-year and adjusted for currency effects) to € 488 million. FIRST LINE®, which is indicated for the treatment and prevention of fleas, ticks and biting lice in dogs and cats, generated net sales of 267 million euros, up 8.9% (d year on year and corrected for currency effects).

HEARTGARD net sales®, the heartworm prevention product for dogs, edged down 0.2% (year-on-year and currency adjusted) to € 173 million. Net sales of INGELVAC CIRCOFLEX swine vaccine® continued to recover in many countries with the decline of African swine fever. INGELVAC CIRCOFLEX® revenue increased 18.1% (year-on-year and adjusted for currency effects) to 145 million euros.

Contract manufacturing of biopharmaceuticals: inauguration of a new production site in Vienna, Austria, in October

Demand for contract manufacturing of biopharmaceuticals remains high. Net sales increased 1.1% (year-on-year and adjusted for currency effects) to € 322 million. Boehringer Ingelheim is further expanding its biopharmaceutical production capacity to continue to meet growing demand. The company will inaugurate its large-scale cell culture facility (LSCC) in Vienna, Austria, in October, featuring up to 150,000 liters of manufacturing capacity for Boehringer Ingelheim products and contract manufacturing.

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