Nexavar fails in liver cancer


Bayer and Onyx's cancer treatment Nexavar has failed to show benefit in preventing the return of liver cancer after surgery.

The drug is already approved in patients with hepatocellular carcinoma (HCC, the most common form of liver cancer) whose disease is too advanced for surgery, and the firms were hoping the drug could benefit those with less advanced tumours.

But data from the phase III STORM trial found Nexavar (sorafenib) did not meet its primary endpoint of extending recurrence free survival.

The trial included approximately 1,100 patients who were randomised to receive 400 mg of sorafenib twice daily or matching placebo for four years or until disease recurrence, whichever occurred first after surgical resection or local ablation.

Nexavar is also already licensed to treat renal cell carcinoma (kidney cancer) and added its third indication, for differentiated thyroid carcinoma (DTC), in November last year.

The drug has been struggling to compete in the larger renal cell carcinoma market, where it is up against rivals such as Pfizer's Sutent. Nexavar saw its sales fall back in 2013 because of this, slipping back 2.7 per cent to €771 million in full year revenues.

Bayer confident of growth

Despite the setback to expansion plans for Nexavar, the firm say it is confident about growth in its pharma division.

"I'm particularly confident about our health care business thanks to the encouraging development of the five pharmaceutical products we have recently launched," said chief executive Marijn Dekkers at an investor conference today.

Bayer recently raised its combined peak sales forecasts for its lead pharma products to at least €7.5 billion from the previous figure of €5.5 billion. Total sales of anticoagulant Xarelto, the eye medicine Eylea, cancer drugs Stivarga and Xofigo and pulmonary hypertension drug Adempas (riociguat) are planned to reach around €2.8 billion in the current year.

Bayer aims to grow pharmaceuticals sales by an average of 8% annually up to and including 2016 after adjusting for currency and portfolio effects, with an EBITDA profit margin before special items in Pharmaceuticals is planned to reach at least 33 per cent.


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12 March, 2014