Daiichi Sankyo Co. Ltd., of Tokyo, reported data from two pre-specified subgroup analyses of East Asian patients with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) enrolled in two phase III edoxaban studies. The findings of the two subgroup analyses of 1,943 East Asian patients (Japan, mainland China, Korea and Taiwan) enrolled in the ENGAGE AF-TIMI 48 study and 1,101 East Asian patients enrolled in the Hokusai-VTE study were consistent with the results from the global study populations, which showed investigational edoxaban was comparable to warfarin for the prevention of stroke or systemic embolic events in NVAF patients and to treat and prevent VTE, respectively. The data were presented at the Japanese Circulation Society 2014 Annual Scientific Meeting in Tokyo.
Ferrer Internacional SA, of Barcelona, Spain, licensed commercialization rights for Ozenoxacin 1 percent cream in the U.S., Puerto Rico and the U.S. Virgin Islands to Medimetriks Pharmaceuticals Inc., of Fairfield, N.J. Under terms of the agreement Ferrer will be eligible to receive development milestones and revenues from sales in the Medimetriks territory.
Medivir AB, of Huddinge, Sweden, said the Russian Ministry of Health has approved Sovriad (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir.
Otsuka Pharmaceutical Co. Ltd., of Tokyo, said Samsca (tolvaptan) has been approved in Japan in 7.5-mg and 15-mg tablet forms for extended use for autosomal dominant polycystic kidney disease (ADPKD). An application was filed in Europe and is under review. The company received a complete response letter from the U.S. FDA in August 2013. Discussions with the agency are ongoing regarding supplementary data and the path forward for resubmission.
Sirtex Medical Ltd., of Princeton, N.J., and Guerbet S.A., of Roissy, France, (GBT.PA) are collaborating to evaluate the unmet clinical need in patients with hepatocellular carcinoma, metastatic colorectal cancer, neuroendocrine tumors and other secondary liver cancers. Deal details are still being finalized, with additional announcements expected this year.
Taiho Pharmaceutical Co. Ltd., of Tokyo, obtained approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market the oral combination anticancer drug Lonsurf combination tablet T15, T20 (nonproprietary names: trifluridine and tipiracil hydrochloride; development code: TAS-102), for the treatment of patients with unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies). Taiho said Japan is the first country in the world to grant marketing authorization for Lonsurf. The approval is based primarily on the results of a randomized, double-blind, placebo-controlled phase II trial conducted in Japan. Taiho is conducting a global phase III trial (RECOURSE) on patients with metastatic colorectal cancer refractory to standard chemotherapies. Lonsurf is a combination drug of trifluridine (FTD) and tipiracil hydrochloride.