Boehringer Ingelheim’s top product, Spiriva, fell faster than expected in 2016 but its new big hope, Jardiance, is already showing signs that it can fill the gap. Sales of the diabetes therapy totalled €433m ($460m) last year, beating EvaluatePharma forecasts – and this is before taking into account its new cardiovascular label, which was approved in the US at the end of last year.
“In the big markets the kick is still to come,” Allan Hillgrove, who heads up Boehringer’s human pharma business unit, told EP Vantage at its annual press conference this week. He added that the company had already seen an increase in new-to-brand prescriptions, even though it has only been promoting the cardiovascular label there for a few weeks.
EvaluatePharma estimates that 2017 in-market Jardiance revenues will hit $929m, rising to $3.5bn by 2022. Boehringer, being private, does not put out forecasts, but Mr Hillgrove said: “I think Jardiance has lots of upside.”
Expectations for the product, which is co-promoted with Lilly, might increase further if it succeeds in upcoming trials in chronic heart failure patients with or without diabetes – although these will not read out for several years.
However, Jardiance’s rise could be slowed by positive cardiovascular outcomes data for other products in the SGLT2 inhibitor class.
Johnson & Johnson expects results from the Canvas trial of its contender, Invokana, this year, while the Declare-Timi58 study of Astrazeneca’s Farxiga will read out in 2019 (Event – J&J needs to paint a heartening picture with Canvas, February 7, 2017).
Boehringer execs, though, do not seem fazed. Its chairman, Hubertus von Baumbach, said he would “be glad to take up challenges posed by other products” should those trials report positive results. “On the whole we feel our product will continue to convince because of its quality and the excellent data.”
Mr Hillgrove added: “There are two sides to it. I’d rather we had exclusivity for a bit longer. But I think if the competitors come up with similar data it will certainly lead to dramatic growth in the class.”
This growth could come at the expense of other diabetes drug classes, including the GLP1 agonists, which have shown a less emphatic cardiovascular benefit.
So far, the signs point to a class effect with the SGLT2 inhibitors: a six-country registry analysis presented at the recent American College of Cardiology meeting suggested that Jardiance, Invokana and Farxiga all conferred a cardiovascular benefit (ACC – Jardiance heart benefit looks like a class effect, March 20, 2017).
“There have been a few real-world studies out there, which I think are interesting, but there’s nothing quite like a controlled trial,” Mr Hillgrove said.
The Empa-Reg Outcome results should give Boehringer the edge in US pricing discussions, he added, at least until its rivals report their cardiovascular outcomes data.
Meanwhile, “in Europe it strengthens our case, but it’s probably a little bit naive to think that the authorities are going to give you a price increase because of the data.” Here, there will likely be a bigger impact on sales volume and share within the class than on price, he said.
For now, Boehringer is in the driving seat. “At the moment, we have the data and we have the label, and our competitors don’t yet," Mr Hillgrove said. "Let’s see what their data say.”
|Study||Setting||Trial ID||Primary completion|
|Emperor-Preserved||Chronic heart failure with preserved ejection fraction||NCT03057951||June 2020|
|Emperor-Reduced||Chronic heart failure with reduced ejection fraction||NCT03057977||June 2020|