November 8, 2017 / 6:48 AM / 2 years ago

Novartis takes fight to Pfizer's Ibrance with new Kisqali data

ZURICH (Reuters) - New data from Novartis’s breast cancer drug Kisqali underscored its effectiveness in pre-menopausal women, the Swiss drugmaker said, amid efforts to muscle in on turf dominated by rival Pfizer’s Ibrance.

Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann

A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone, Novartis said on Wednesday.

Sales of Ibrance, whose 2015 approval gave it a head start over Kisqali, doubled to $643 million last year. That dwarfs Kisqali’s third-quarter 2017 revenue of $26 million after it won U.S. and European approvals this year against breast cancer in women after menopause.

Novartis, which now aims to expand Kisqali’s use in pre-menopausal patients, sees the drug as an eventual $1 billion-per-year seller and a linchpin of its plan to return to revenue growth starting in 2018.

“There remains a significant unmet treatment need in younger women diagnosed with pre-menopausal advanced breast cancer, as the disease tends to be more aggressive with a poorer prognosis” than in women after menopause, said Samit Hirawat, head of global drug development at Novartis Oncology.

Efforts to broaden Kisqali’s use come as the crowd of so-called CDK4/6 inhibitors designed to block certain enzymes blamed for spurring tumor growth is expanding. Eli Lilly’s Verzenio won U.S. approval in September.

While Novartis will wait until a December cancer symposium in San Antonio to give specifics of the latest Kisqali study, analysts said initial data bode well for the medicine’s getting a leg-up against Ibrance in pre-menopausal women.

Moreover, the absence of new safety issues — Kisqali already has warnings for so-called QT prolongation, which can signal heart and liver problems — will also be reassuring.

“The indication clearly helps differentiate this CDK 4/6 inhibitor from its competitor Ibrance, which so far benefited from a 2-years lead... and a milder tolerability profile,” said Baader Helvea analyst Bruno Bulic.

He estimates Kisqali will eventually reach peak annual sales of $5 billion.

Editing by Michael Shields

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