Boehringer Ingelheim and Eli Lilly’s (NYSE:LLY) SGLT2 inhibitor Jardiance has already shown it can reduce cardiovascular events and deaths in patients with diabetes, but the companies have got even bigger hopes for the drug. They have just announced plans for two new trials in chronic heart failure that could expand its sales beyond the $2.7bn 2020 sellside consensus forecast.
The cardiovascular benefits seen with Jardiance represent a breakthrough “comparable to the launch of statins in lowering cholesterol”, said Boehringer chief Andreas Barner during the company’s annual press conference.
Allan Hillgrove, head of the group’s prescription medicines business, was more cautious, telling EP Vantage: “Will it be as large as statins? Let’s wait and see. But I think certainly it’s going to be a multi-blockbuster.”
Details about the two new trials were scant, but they will enrol patients both with and without diabetes, should take three to four years to complete and will compare Jardiance with placebo, both on top of the current standard of care. The costs of the trials will be split between Boehringer and Lilly, Mr. Hillgrove added.
Cardiovascular risk reduction
The companies will be hoping for a repeat of the Empa-Reg Outcome trial, which found a 38% reduction in cardiovascular death (EASD – Lilly blooms with full Jardiance outcomes data, September 18, 2015).
Boehringer is still trying to elucidate the exact mechanism of action behind the cardiovascular effects of Jardiance, a spokesperson told EP Vantage – but the company believes it could be multifactorial, “with an osmodiuretic effect, the loss of sodium and a blood pressure-reducing effect all potentially contributing”.
The spokesperson added: “We also believe that the effect is not likely linked to glucose lowering, because we’ve not seen this positive effect with other classes of diabetes drugs.” If true, Jardiance could have broad utility outside diabetes – although it may have a fight on its hand with Novo Nordisk's (OTCPK:NONOF) GLP-1 Victoza (Leader could give Novo pushback power in payer wars, March 4, 2016).
In the meantime, Lilly and Boehringer will seek an expansion of the drug’s current label to include claims of cardiovascular risk reduction; a regulatory filing is expected this year or early next year, said Mr. Barner.
But while Jardiance is one of Boehringer’s big hopes for the future, it was mainly Tradjenta that helped it increase its diabetes sales by 49% in fiscal 2015, against a background of overall constant currency revenue growth of 4%. Mr. Barner declined to break down Jardiance’s sales but added that more details should be available next year.
The diabetes growth is good news for Boehringer after some recent disappointments, notably the anticoagulant Pradaxa, which has failed to live up to expectations. The company believes that revenues should pick up this year, partly helped by the approval last year of its reversal agent, Praxbind.
Mr. Hillgrove gave Pradaxa as one example of an agent where Boehringer has had “preliminary discussions” with payers over potential risk-sharing arrangements – but stressed that this was not down to the disappointing sales. The company is also considering risk-sharing arrangements for other products, but he did not say what these were.
Boehringer is aware that the pharma market is changing and is trying to adapt – whether through the aforementioned new payer models, sharpening its focus by offloading its generics and consumer divisions, or an increased emphasis on partnerships.
The German group claims to be one of the most active pharma companies in terms of partnering, with around 50% of its early-to-mid-stage pipeline having emerged from external collaborations.
Mr. Barner highlighted the recent deal with AbbVie (NYSE:ABBV) covering its phase III psoriasis candidate, the IL-23-targeting asset BI 655066, and the anti-CD40 antibody BI 655064, currently in phase I in rheumatoid arthritis (Next-generation psoriasis battle lures AbbVie, March 8, 2016).
However, he noted that Boehringer probably does not have any more capacity for more late-stage collaborations like this, and in the future will look for deals with smaller companies or academic institutions.
Mr. Barner will retire on June 30 and be replaced at the helm by Hubertus von Baumbach, who is currently head of finance. One thing looks certain under the new leader: Boehringer is not for sale. During the press conference, Mr. von Baumbach brushed off the question of whether the company will be acquired, saying that independence was its “highest management objective.”