Jardiance development 'one of biggest programmes ever' - Boehringer

by Sabine Ohlenbusch
BERLIN, 10 July (APM) - The development programme for the use of Lilly/Boehringer’s SGLT-2 inhibitor Jardiance (empagliflozin) outside of diabetes is "one of the biggest clinical development programmes ever" in cardiometabolism, Boehringer Ingelheim told APM.
"We are developing the drug in non-diabetes indications for cardiovascular benefits and also for kidney disease," Boehringer's head of pharma Carinne Brouillon told APM in a Wednesday online interview.
However, as development "always depends on the data", it is not clear in which of the indications Jardiance will be approved in the end, she added.
In diabetes, Jardiance is "very successful" because Boehringer has "great data that show the impact we have on patients", Brouillon said.
Jardiance has become Boehringer's top-selling drug with sales rising 47% to €2.15 billion in 2019. (APMHE 66901)
Brouillon explained that the EMPAREG-OUTCOME study was a "landmark trial" and has prompted Jardiance to be recognised in more than 50 medical guidelines globally.
In the EMPAREG-OUTCOME study, Jardiance lowered cardiovascular mortality by 38% in high-risk patients (APMHE 44107).

Real-world evidence

Brouillon said that Boehringer buys real-world evidence (RWE), which is helpful to better understand the disease, from some countries where this is permitted.
Having access to data is "absolutely key" for the future of medicine and to develop "tailor-made" drugs instead of "one-size-fits-all", she said.
"It would be good to have access [to RWE] in every country to address payers' specific questions because we know populations are a bit different based on culture, food etc," she said. For that reason, it would be important to have access to German data, she added.
In Germany, pharma lobbies and companies have repeatedly called for access rights to the national research data centre, which collects payer data and has been introduced under recent legislation (APMHE 67497) and to data that can be donated by patients from their electronic health records from 2023 (APMHE 68031).
Boehringer is aware that data have become "something consumable" and "has a value", so the company agrees to pay for RWE, Brouillon added.

R&D strategy in ophthalmology

Brouillon also gave details about Boehringer's newest research and development (R&D) strategy on retinal diseases, which was announced in April (APMHE 66905).
She said that Boehringer started in retinopathy as a diabetic complication "to go on [to] a broader range of indications" because the medical need in this area is high: "We know that 70% of legal blindness is due to retinal diseases and there are little to no treatment options," she said.
Boehringer is testing existing assets from its internal R&D division for their potential in retinal diseases and is also "looking at external partnerships" to build up a portfolio consisting of "breakthrough innovation, new mechanisms of action, new ways of administration", she added.
To date, Boehringer's ophthalmology portfolio consists of three clinical-stage candidates: anti-inflammatory AOC3 inhibitor BI 1467335, in Phase II for diabetic retinopathy and two candidates in Phase I, a neuronal damage modulator and a VEGF/Ang-2 antibody.
Also, Boehringer has announced partnerships with Swiss biotech Numab Therapeutics for the development of an antibody drug candidate in retinal diseases (APMHE 68061) and with Swiss biotech CDR-Life on antibody fragment-based therapeutics for geographic atrophy and Inflammasome Therapeutics on an intravitreal drug delivery technology (APMHE 67316).

Strategic Hikma divestment

Boehringer sold its stake of 16.5% in Jordan-based and London-listed generics group Hikma in June (APMHE 67868), as Boehringer wants to "focus on innovation and being the partial owner of a generics company just did not fit with this strategy".
Brouillon said that Boehringer had received the 40 million shares, worth £992 million to date, when it sold U.S.-based generic drugmaker Roxane to Hikma in 2016.
"Boehringer kept the shares and we revised our strategy and refocused. So this is why we decided to concentrate on developing innovative drugs and then sell the shares," she said.



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