Bayer Thins R&D Pipeline, Backs Finerenone In Kidney But Not Heart Disease

The German multinational Bayer AG has bowed to the likely highly competitive nature of the congestive heart failure (CHF) market in future years by not starting a Phase III study of the mineralocorticoid receptor antagonist finerenone in the condition, saying the decision was made for “commercial reasons”.

Still, finerenone will continue to be evaluated for use in the treatment of diabetic kidney disease in an ongoing Phase III study, reported Bayer’s outgoing CEO Marijn Dekkers during a first-quarter analyst’s briefing held Apr. 26.

The company said it would also only continue to evaluate in late-stage studies the guanylate cyclase (sGC) stimulator vericiguat in CHF patients with a reduced ejection fraction, and not those with a preserved ejection fraction. A Phase II study in patients with heart failure with a preserved ejection fraction did not meet its endpoint, Dekkers noted. Vericiguat is being developed in a partnership with Merck & Co. Inc..

And because of the highly competitive nature of drugs being developed for renal anemia, Dekkers said Bayer was also evaluating whether to proceed with Phase III studies of the hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor molidustat, or whether to find a development partner or license it out. Top-line results of Phase II studies with molidustat showed a positive outcome, but a Phase III program would require larger outcome studies, the Bayer executive said.

Bayer's Marijn Dekkers

Analysts questioned why the competitive landscape in heart failure was different for finerenone and vericiguat, with Bayer’s pharma division head Dieter Weinand responding by saying the decisions depended on the expected commercial environments for the two products. The diabetic kidney disease indication was always the main driver of finerenone’s development, while it has already been decided that vericiguat would go into Phase III later this year, in CHF patients with reduced ejection fractions, Weinand said.

The answers didn’t completely satisfy analysts, who pointed out Novartis AG’s Entresto (sacubitril plus valsartan) has been considered to be a new gold standard in CHF for more than a year, and Bayer’s decision doesn’t appear to have been triggered by more data.

Cancer Drugs Discontinued

Other mid-stage pipeline products could be discontinued by the company. A decision to continue with the development of the PI3K inhibitor copanlisib for non-Hodgkin’s lymphoma will depend on the results of Phase II studies that are running in parallel with Phase III studies, Dekkers said. The Phase II data are expected in the third quarter of this year.

During the first quarter of 2016, Bayer has already decided not to pursue the development of the investigation product refametinib in cancer, and has returned the project to Ardea Biosciences Inc.. The company has also ended the development of BAY 1007626 and roniciclib. But one piece of good news was that Bayer intends to move the oral progesterone receptor modulator vilaprisan into Phase III for uterine fibroids, after a first Phase II trial in the condition indicated it had a “very competitive” profile.

Pipeline Still Strong

Is Bayer’s mid-term pipeline strong enough to eventually replace its current high-growth marketed products? Weinand told analysts the company has 17 new products in Phase III and 18 in Phase II, including finerenone, vericiguat, vilaprisan and the partial adenosine A1 agonist BAY 1067 197.

The company also has ODM-201 in Phase III studies for non-metastatic castrate-resistant prostate cancer, another anticancer anetumab in Phase II, and is evaluating its radiotherapeutics platform. And although Bayer has not participated in the first wave of immune-oncology products, it expects to be present during the next wave of such products, Weinand said.

Analysts at Deutsche Bank noted the pipeline rationalization announced will likely keep commentators focused on Bayer’s plans for pipeline renewal that is likely to include a combination of in-licensing, acquisition and in-house projects. Credit Suisse analysts were more concerned, saying the pipeline update was a significant fall-out from an already thin pipeline.

In the 2016 first quarter, Bayer’s pharmaceutical sales increased by 12% to €3.9bn ($4.4bn), driven by five recently launched products, Xarelto (rivaroxaban), Eylea (aflibercept), Stivarga (regorafenib), Xofigo (radium-223 dichloride) and Adempas (riociguat), whose sales in total amounted to €1.2bn, up 35% on the previous first quarter and representing nearly a third of the company’s pharmaceutical sales. Xarelto gained market share and is the leading anticoagulant worldwide, Eylea sales were up 49% on the previous first quarter, and Xofigo sales increased by 37%. During the quarter, group sales increased by 3% at constant currencies to €11.9bn, led by its life sciences businesses, and reported EBIT increased by 20% to €2.3bn.

Bayer executives said the company was committed to divesting its majority stake in the polymer and performance materials spin-out Covestro, and in continuing with its animal health business. “It is a great industry. A lot of people would die to be present in that industry,” said Werner Baumann, the incoming Bayer CEO who is currently its chief strategy and portfolio officer. “You can be assured that we will continue to look at ways to strengthen the business,” he added. Baumann takes over as CEO on May 1 (Also see "Bayer Chief Dekkers Departs With Words Of Warning, Wisdom For Pharma" - Scrip, 25 Feb, 2016.).