GERMANY – Bayer pharmaceuticals has appointed Christine Roth, currently the head of GSK’s global oncology therapy area, to head its new oncology business, effective March 1.

Roth has a lot of work ahead of her. Roth will set out to lead the charge in realizing Bayer’s blockbuster expectations for prostate cancer drug Nubeqa despite stiff competition from rivals at a company that only plays in a small segment of the oncology market.

Bayer has long been a major player in cardiovascular disease. The aspirin maker’s best-selling medication is Xarelto, a blood thinner co-developed with Johnson & Johnson that generated €3.5 billion (US$4 billion) in sales for the company in the first nine months of 2021.

In comparison, its best-selling oncology products, liver cancer therapies Stivarga and Nexavar, ranked ninth and tenth in its overall pharma portfolio, respectively. During the same time period, the drugs generated a total of €701 million (US$801.18 million) in sales.

As Xarelto faces generic competition in key markets, Bayer has identified four potential blockbusters to help close the sales gap.

Among them, meeting Nubeqa’s estimated €1 billion (US$1.14 billion) in peak sales will almost certainly be Roth’s top priority.

Nubeqa’s launch has been slow thus far. The androgen receptor inhibitor, which was approved by the FDA in mid-2019 for men with non-metastatic castration-resistant prostate cancer, had yet to make Bayer’s list of top 20 drugs as of the third quarter.

Its narrow label, combined with an uphill battle against Pfizer and Astellas’ dominant Xtandi and J&J’s newer Erleada, could explain the drug’s slow ramp.

However, opportunity awaits. Nubeqa could soon see a label expansion into metastatic hormone-sensitive prostate cancer, matching up with Erleada’s two existing indications.

The J&J competitor drug generated US$1.29 billion in global sales in 2021, thanks to a 69 percent increase in sales year over year.

I feel privileged to join Bayer at a time where new exciting paths are taken to develop and bring transformative therapies to patients. I look forward to being part of making a difference for cancer patients and their families worldwide.”

Christine Roth, Senior Vice President, Global Oncology Therapy Area Head at GlaxoSmithKline

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Bayer also sells the radiotherapy medicine Xofigo for prostate cancer in addition to Nubeqa. That drug will also compete with Novartis’ 177Lu-PSMA-617, which is expected to be approved by the FDA in the first half of 2022.

Bayer recently acquired Noria Therapeutics and its subsidiary PSMA Therapeutics in order to gain control of two investigational radiotherapies in prostate cancer.

Roth, who has worked at BMS, Novartis, and GSK, will take over from Robert LaCaze as head of the unit.

Her experience in Big Pharma includes oncology marketing at BMS, commercialization efforts for GSK’s oncology franchise at GSK, and being VP and head of Novartis’ breast cancer franchise before returning to GSK.

GSK re-entered the commercial oncology market in 2019 with the acquisition of Tesaro, the maker of the PARP inhibitor Zejula. J&J, the owner of Zejula’s commercial rights in prostate cancer, is also looking to carve out a niche market for the disease, which could put Nubeqa under even more pressure.

Other challenges for Roth include reaching Vitrakvi’s peak sales potential of approximately €750 million (US$857.18 million) in the face of fierce competition from oncology major Roche’s Rozlytrek in NTRK-driven solid tumors.

At Bayer, the drug is also not yet large enough to warrant separate sales reporting.

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