Bayer looks beyond Xarelto and Eylea

Bayer’s Xarelto and Eylea are expected to dominate its revenues for years to come, and today's full-year financial results highlighted just how reliant it is on these two superstars.

But the German company insists that it is looking to the future, with its chairman, Werner Baumann, highlighting six mid to late-stage products that he says will bring in over €6bn ($6.3bn) combined at their peak – in line with EvaluatePharma sellside consensus (see table below). Which of these could become the next Xarelto?

In answer to this question Dieter Weinand, head of Bayer’s pharma division, singled out the antibody-drug conjugate anetumab ravtansine. This is in phase II for the relatively intractable disorders mesothelioma and pancreatic and ovarian cancers, and could “make a huge difference in patients’ lives”, he told EP Vantage.

But it is the diabetic kidney disease candidate finerenone that has the biggest peak forecast, according to EvaluatePharma. Mr Weinand said this was one example of where the company had tried to be more strategic lately, focusing on projects where it has a chance to be either first or best in class.

The group had been developing finerenone in congestive heart failure, but chose to pivot to diabetic kidney disease where there is less competition. The project is in two phase III outcomes studies – one renal, one cardiovascular – that are expected to read out in 2019.

Project Indication Mechanism Status Peak global sales ($m)
Finerenone Diabetic kidney disease Mineralocorticoid receptor antagonist Phase III 1,847
Vericiguat (Merck & Co-partnered) Congestive heart failure Guanylate cyclase activator Phase III 1,583
ODM-201/ BAY-1841788 Prostate cancer Androgen receptor antagonist Phase III 1,055
Copanlisib NHL PI3K inhibitor Phase III 924
Anetumab ravtansine Mesothelioma; ovarian and pancreatic cancers Anti-mesothelin MAb-DM4 maytansinoid conjugate Phase II 792
Vilaprisan Endometriosis Selective progesterone receptor modulator Phase II 607
Total 6,908
Source: EvaluatePharma.

Closer to the market could be the non-Hodgkin's lymphoma project copanlisib, for which Bayer plans to seek accelerated approval this year based on results from the phase II Chronos-1 trial.

This month it set up a separate, semi-autonomous oncology business unit which combines various functions; the division will be looking to utilise the accelerated approval pathway to “hopefully help us get to market faster”, Mr Weinand said.

This unit will be headed by Robert LaCaze, previously of Bristol-Myers Squibb, and will encompass Bayer’s marketed cancer drugs as well as its entire oncology pipeline.

Old blood

Meanwhile, there is still life in Xarelto, and recent top-line results from the Compass study could expand its use into patients with coronary or peripheral artery disease (Xarelto scores again in huge heart trial, February 9, 2017). 

Mr Weinand was reluctant to disclose any more details, but did say Bayer would engage with the regulatory authorities as soon as possible. During the press conference, he said coronary or peripheral artery disease affect around the same number of patients as atrial fibrillation, the biggest current patient population for Xarelto.

As such, Bayer’s dependence on its top products is not going away: Xarelto and Eylea are forecast to bring the company $4.6bn and $2.3bn respectively in 2022. But at least some of its new development-stage drugs might be able to help prepare it for a future without these blockbusters. 

Project Study Trial ID
Finerenone Fidelio-DKD NCT02540993
Finerenone Figaro-DKD (CV outcomes) NCT02545049
Copanlisib Chronos-1 NCT01660451

To contact the writer of this story email Madeleine Armstrong in London at madeleinea@epvantage.com or follow  @ByMadeleineA on Twitter

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