Bayer’s Prostate Cancer Drug Nubeqa on Track to Generate Blockbuster Sales in 2024
22 Mar 2024
Phase 3AcquisitionDrug Approval
Pictured: Exterior of Bayer's headquarters in Berlin/iStock/Umut Tolga Pehlivan
Bayer hailed its prostate cancer drug Nubeqa (darolutamide) as the fastest growing androgen receptor inhibitor in the U.S. Thursday, tipping the drug to achieve blockbuster status this year and outlining areas for future growth.
Sales of the androgen receptor inhibitor Nubeqa almost doubled last year, climbing to €869 million ($948 million). The increase, which Bayer said made Nubeqa the fastest-growing drug in its class in the U.S., emboldened the company to predict on an earnings call early this month that the product could bring in sales of more than €1 billion in 2024.
Thursday, Bayer used its annual Pharma Media Day 2024 to affirm its confidence in the growth prospects of the drug. Nubeqa is “on track to reach blockbuster status this year,” Bayer said, and upcoming clinical trial readouts could support further growth.
Bayer named the ARANOTE study, which is scheduled to report results this year, as the next important data readout for Nubeqa. The placebo-controlled Phase III trial is assessing the effect of adding Nubeqa to standard androgen deprivation therapy in people with metastatic hormone sensitive prostate cancer. Bayer selected progression-free survival as its primary endpoint.
Beyond ARANOTE, Bayer sees the release of further trial data from ARASTEP and DASL-HiCAP as a chance to expand the label for Nubeqa. The results could support the use of Nubeqa in earlier lines of therapy, increasing the number of patients who are eligible for treatment.
In 2022, Bayer identified approvals for Nubeqa in additional indications as milestones that could enable it to grow sales to $3 billion. The company predicted such sales may be possible between 2027 and 2029 if data support the expansion of the Nubeqa label. Securing label expansions could lead Nubeqa sales to peak before the 2030 to 2034 window when the product is set to start losing patent protection.
The timeline suggests growth of Nubeqa could help Bayer to mitigate the impact of the loss of exclusivity for Xarelto (rivaroxaban), the anticoagulant medication that generated revenues of €4.1 billion last year. Bayer has been involved in disputes over when generic Xarelto competitors will come to market. The company said a 2021 decision by the European Patent Office secured one patent into 2026.
Bayer used the Pharma Media Day to highlight other drugs that can cushion the blow of losing Xarelto exclusivity. In oncology, the company is advancing assets acquired in its takeover of Vividion. Bayer also has cell and gene therapies due to the €3.5 billion ($3.79 billion) it has invested in the modalities since 2020.
On Wednesday, Bayer announced sweeping changes to its leadership structure, including a new unit, role changes and a more streamlined masthead. The pharma’s executive roster will now have only eight members, down from 14 positions.
Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.
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