Patent expiries loom as Bayer looks to mid-2020s for return on cell, gene therapy bets
Bayer's head of pharmaceuticals Stefan Oelrich said Wednesday that new drugs from the company that are each projected to generate more than $1 billion in annual sales will not be enough to bridge the gap from falling revenues when its anticoagulant Xarelto (rivaroxaban) and eye treatment Eylea (aflibercept) lose patent protection. Meanwhile, Oelrich predicted it will take at least until the middle of the decade for Bayer's recent investments in cell and gene therapies to show a meaningful financial return, but he suggested the impact could be large over the medium term, with seven advanced cell and gene therapy assets currently in clinical development.
Xarelto (rivaroxaban)
Xarelto and Eylea, whose patent expiries are set to start in stages globally this year, account for more than a third of Bayer's pharmaceutical revenues, generating more than €6 billion ($7.3 billion) annually between them. Speaking ahead of a Bayer media day focused on the pharmaceuticals business, Oelrich said "no company in the world…would be able to fill such a gap just at once," adding this would be "mathematically impossible."
Nubeqa beats sales expectations
However, the executive pointed to three new drugs with blockbuster potential that may help Bayer wade through the period ahead, including Nubeqa (darolutamide), an Orion-partnered androgen receptor inhibitor approved in the US and Europe for non-metastatic castration-resistant prostate cancer. Oelrich did not disclose exact sales figures for the drug, but said it "is exceeding all our internal expectations." He added that Nubeqa is also "unmatched in its effects and side-effects profiles, and that is something we hear back from doctors too."
Nubeqa (darolutamide)
The other pharmaceutical products Bayer is pinning its blockbuster hopes on are finerenone, a mineralocorticoid receptor antagonist that the FDA accepted for priority review earlier this week for use in patients with chronic kidney disease and type 2 diabetes, as well as NT-814, a dual inhibitor of NK1 and NK3 receptors to treat menopausal symptoms. NT-814, which Bayer gained via its acquisition of KaNDy Therapeutics last year, is scheduled to enter last-stage trials this year and could be launched in 2024.
Pivot to cell, gene therapies
Commenting on Bayer's prospects, Berenberg analyst Sebastian Bray said the company's "pipeline is light, especially in oncology, but [it] has some more promising products." However, he believes the move into cell and gene therapies was correct as these "are the higher growth markets in pharma."
The drugmaker launched a devoted cell and gene therapy platform within its pharmaceuticals division last month, following prior acquisitions of BlueRock Therapeutics, which gave it a foothold in cell therapies, and Asklepios Biopharmaceutical, a company focussed on adeno-associated virus gene therapies. "We are aiming to launch at least three new clinical substances per year," said Oelrich, noting that the R&D cycles and approval processes in this field tend to be shorter than those for traditional pharmaceuticals.
Aside from the seven advanced cell and gene therapy assets, which the company says span areas of high unmet need, such as neurodegenerative, neuromuscular and cardiovascular indications, with leading programmes in Pompe disease, Parkinson's disease, haemophilia A and congestive heart failure, Bayer also has over 15 preclinical assets in this field. The company anticipates the pipeline will "grow steadily" every year.
Meanwhile, last week, Bayer struck a development and supply deal aimed at advancing CureVac's COVID-19 vaccine candidate CVnCoV. The companies indicated that the alliance would put CureVac in a position to be able to supply "hundreds of millions" of CVnCoV doses around the world, once approvals are granted. For related analysis, see ViewPoints: Pandemic to help shape deal-making in 2021 and beyond says new report, as JP Morgan kicks off.
January 13th, 2021
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