Diabetes drug sales ease Boehringer's patent-loss pain

As sales of its blockbuster asthma and COPD drug Spiriva flagged in 2018, Boehringer Ingelheim needed a boost from its other products. Turns out diabetes was the key.

The German drugmaker reported an impressive 52.5% increase in sales from its partnership with Eli Lilly on the Jardiance family of SGLT2 diabetes drugs, including Synjardi and Glyxambi. That strong showing, presented Wednesday at Boehringer's annual earnings conference, delivered €1.8 billion ($2.03 billion) in sales, according to a release.

Jardiance's landmark cardiovascular outcomes trial gave the franchise a big boost, CEO Hubertus von Baumbach said in prepared remarks Wednesday morning. That study, Empa-Reg, showed the drug could cut CV and kidney failure risks in diabetes patients, von Baumbach said, and the partners aren't done looking for new Jardiance indications.

"For the active ingredient of (Jardiance), we are working on entirely new areas for application," he said. "We are convinced that we are able to make considerable progress in the therapy of chronic heart failure and chronic renal insufficiency for people with or without diabetes."

Jardiance's blockbuster success comes at a good time. Boehringer's top line has been suffering from Spiriva's copycat rivals, and the respiratory med continued its decline last year. Spiriva sales dropped an adjusted 11.4% to €2.4 billion ($2.71 million), dragged down by increased competition from generics in the asthma and COPD markets.

Overall, BI reported a 3.3% decrease in total operating revenues for 2018. 

But can Jardiance continue its steep climb? As the Lilly-Boehringer med rises in the SGLT2 field, it's competing with rivals that boast some impressive outcomes results of their own.

In March, AstraZeneca revealed outcomes trial data showing its SGLT2 drug Farxiga helped reduce hospitalizations in diabetes patients with heart failure, with the biggest risk reductions among patients with reduced ejection fraction, a measure of how well the heart pumps blood.

Among patients with a reduced ejection fraction, the rate of hospitalizations was 36% lower for those using Farxiga versus those taking a placebo. For patients without a reduced ejection fraction, Farxiga lowered the hospitalization rate by 24%.

Meanwhile, J&J’s Invokana received a label expansion in October 2018 showing its ability to reduce the risk of major heart problems—including heart attack, stroke and cardiovascular death—in high-risk Type 2 patients. That FDA approval follows a similar CV label expansion that Jardiance won in 2016. And Invokana just put up data in patients with chronic kidney disease earlier this week, ahead of an FDA decision that could add CKD data to its official label. 

However, Invokana also comes with a safety issue that Jardiance doesn’t have, and that’s a risk of lower extremity amputations. Invokana bears a black box warning, the FDA’s most serious, highlighting the risk of toe, midfoot and leg amputations.

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