Research briefs on Merck & Co's boceprevir and Bayer's Xarelto; legal updates from AstraZeneca and Daiichi Sankyo/Actavis

US drug giant Merck & Co has reported results from two pivotal Phase III studies: HCV SPRINT-2 (n=1097) and HCV RESPOND-2 (n=403) of boceprevir, an oral hepatitis C protease inhibitor, for the treatment of chronic hepatitis C. In both the studies, data indicated that addition of boceprevir to treatment with Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) (Peg/riba) significantly increased the percentage of patients who achieved sustained virologic response, compared to control groups who received Peginterferon/ribavirin plus placebo.

Abstracts from these studies were submitted for presentation at an upcoming medical meeting this year, and additional abstracts will be submitted this week. The company plans to submit an NDA for boceprevir to the US Food and Drug Administration on a rolling basis, and expects to complete the European Union and US regulatory submission by the end of 2010.

German major Bayer announced that its anticoagulant Xarelto (rivaroxaban) met the primary efficacy endpoint of non-inferiority in the EINSTEIN-DVT Phase III trial and showed an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT). The full data will be presented at the Hot Line Session on August 31, 2010 at the European Society of Cardiology meeting in Stockholm, Sweden.