BERLIN (dpa-AFX) - Bayer has achieved a trial success with its drug Nubeqa against prostate cancer. The active ingredient darolutamide met the primary endpoint in the final clinical trial (Phase III) Aranote in patients with metastatic hormone-sensitive prostate cancer, the pharmaceutical and agrochemical company announced on Wednesday. The drug in combination with hormone therapy significantly extended radiographic progression-free survival (rPFS) compared to placebo. Applications for an extension of the approval of Nubeqa are now planned, it added.

Analyst James Quigley from the investment bank Goldman Sachs sees no major surprise in the news. Bayer shares were little changed in the morning.

Analyst Emily Field from the British bank Barclays had already explained in a study in mid-June that the success of this study would expand the addressable patient population in view of the frequency of metastases. The study would close a data gap, especially as some doctors have already started to use the drug off-label. This means that a drug is prescribed for a different clinical picture or in a different dosage than the approval actually provides for.

Analyst Quigley also believes that doctors are already using Nubeqa under the circumstances investigated in Aranote. For example, the drug is already approved in many countries in combination with hormone therapy and chemotherapy for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is also used to treat patients with non-metastatic castration-resistant prostate cancer with a high risk of developing metastases (high-risk mCRPC).

Against this backdrop, the Goldman expert believes that the additional potential of Nubeqa, which is already growing strongly, is limited. Sales of the drug had grown strongly to almost EUR 900 million in 2023, making it Bayer's fourth-largest pharmaceutical sales driver.

With new drugs such as Nubeqa, Bayer wants to at least partially compensate for declining sales of its billion-euro bestsellers Xarelto, an anticoagulant, and Eylea, an eye medication.

In the long term, pharmaceuticals boss Stefan Oelrich is counting on a boost from gene and cell therapies, among other things. Bayer has strengthened these areas in recent years with numerous smaller acquisitions. There is not enough money for large deals in view of the burden of the multi-billion dollar US legal disputes surrounding the alleged cancer risks of the weedkiller glyphosate./mis/mne/jha/