Bayer's Xarelto OKed in Japan; promising regorafenib data

Bayer Healthcare, a unit of Germany’s Bayer AG (BAY: DE), had a couple of good news item to report yesterday. First was the approval in Japan of its once-daily oral anticoagulant Xarelto (rivaroxaban) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation by the Ministry of Health, Labor and Welfare (MHLW). Bayer also said it plans to submit regorafenib for approval in metastatic colorectal cancer in 2012, following positive Phase III trial results (discussed below).

The approval of Xarelto by the MHLW is based on the results of the global ROCKET AF study and the J-ROCKET AF study, which was run entirely in Japan. Both studies investigated rivaroxaban versus dose-adjusted warfarin in patients with non-valvular atrial fibrillation at risk of stroke. The J-ROCKET AF trial was conducted with a 15 mg dose of rivaroxaban once daily (10 mg in patients with renal impairment). Results of the J-ROCKET AF study were presented last year in the late breaking clinical trials session at the 23rd Congress of the International Society on Thrombosis and Haemostasis in Kyoto, Japan.

Xarelto is marketed in partnership in the USA with Johnson & Johnson unit Janssen and Bayer has forecast eventual annual sales of some 2 billion euros ($2.53 billion), vying in a market sector to replace warfarin forecast to reach as much as $20 billion.