Bayer has been boosted by the news that regulators in Japan have given the green light to Nexavar for advanced liver cancer.

Specifically, Japan’s Ministry of Health, Labour and Welfare has approved Nexavar (sorafenib) for the treatment of unresectable hepatocellular carcinoma, based on Phase III data which found that the drug extended overall survival by 44% in patients with HCC versus placebo. The oral drug, developed by Bayer and Onyx Pharmaceuticals, is already approved in Japan for kidney cancer.

Gunnar Riemann, member of the executive committee of Bayer HealthCare, noted that the incidence of liver cancer in Japan “is continuing to rise”. He added that this approval, coupled with Bayer’s MRI liver contrast agent Primovist, will help the firm improve early diagnosis and treatment of HCC.

In Japan, 40,000 people are diagnosed with liver cancer each year and 36,000 people die from the disease. Nexavar, which is also being investigated in a wide range of cancers such as breast, lung and ovarian, had first-quarter sales of 137 million euros, up 35.6%, and the Japanese approval can only boost that figure.

Riociguat promise confirmed
Meantime, Bayer has presented previously-released data from a Phase II study on riociguat for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension at the American Thoracic Society meeting in San Diego.

Results from the 12-week, uncontrolled study demonstrated that riociguat significantly improved exercise capacity in a group of 75 patients with CTEPH and PAH. Bayer has begun Phase III studies in both indications and if successful, analysts believe riociguat could be a blockbuster.