Boehringer says R&D pipeline is the best in its long history

Boehringer Ingelheim

Boehringer Ingelheim says it is on track to launch 25 new treatments in its human pharma division onto the market between now and 2030, fuelled by an R&D pipeline that it says is the best in its 139-year history.

The company expects to start around 10 new phase 2 and 3 trials within the next 12 to 18 months, supported by an R&D spend that reached €5.8 billion last year, a rise of 14% and accounting for 22.5% of net sales.

The current pipeline includes nearly 60 assets across 90 indications, said Boehringer’s head of innovation Dr Paola Casarosa, during an annual press conference this morning, with 70% of those programmes having an opportunity to offer first-in-class mechanisms.

She mentioned survodutide – which has been in the limelight following phase 2 results in liver disease due to metabolic dysfunction-associated steatohepatitis (MASH) and has also moved into phase 3 obesity trials – but took the opportunity to highlight Boehringer’s pipeline in other areas.

Top of the agendas was chronic kidney disease (CKD), an area where Boehringer is already making an impact with blockbuster SGLT2 inhibitor Jardiance (empagliflozin). Jardiance was originally developed for diabetes, but has seen its indications extended to include cardiovascular risk reduction and heart failure, as well as CKD.

Casarosa pointed to aldosterone synthase inhibitor BI 690517, which showed its potential as a dual therapy with Jardiance at the American Society of Nephrology (ASN) Kidney Week 2023 congress in a phase 2 trial and is now in phase 3, as well as TRPC6 inhibitor BI 764198 in phase 2 for rare kidney disease focal segmental glomerulosclerosis (FSGS).

In oncology, she highlighted MDM2-p53 antagonist brigimadlin, which has advanced into a pivotal trial for dedifferentiated liposarcoma, a rare cancer with limited treatment options so far, and could be filed for approval later this year. Also heading towards first filings is wild-type and mutated HER2 inhibitor zongertinib, which showed a 74% objective response rate in a phase 1 trial reported at the 2023 IASLC World Conference on Lung Cancer.

Zongertinib is in a phase 3 study in non-small cell lung cancer (NSCLC) trial called Beamion Lung-2, with additional pivotal trials in breast and gastric cancer planned in the second half of this year.

Mental health was also put into the spotlight, with Casarosa singling out two projects – GlyT1 inhibitor iclepertin, which addresses cognitive impairment in schizophrenia, with phase 3 results due next year - and a negative allosteric modulator (NAM) of NR2b NAM for mood disorders, which is heading for late-stage testing in major depressive disorder, and in earlier development for borderline personality disorder and post-traumatic stress disorder.

Last year, Boehringer’s human pharma sales grew more than 10% to €20.8 billion, driven by Jardianc,e which grew by nearly a third on the back of its recent CKD approval as well as pulmonary fibrosis therapy Ofev (nintedanib). According to a Reuters report, the company has now overtaken Bayer as the largest Germany-headquartered pharma group.

For 2024, Boehringer said it expects a “slight” year-on-year increase in revenues.