Astellas Pharma Inc. (ALPMY) and its partner Zeria Pharmaceutical Co., Ltd recently announced that they will be launching Acofide tablets (100 mg) in Japan on Jun 6. Acofide was approved in Mar 2013 by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of functional dyspepsia (FD).
In Mar 2008, Astellas and Zeria had entered into an agreement for the co-development and co-marketing of Acofide.
Acofide is the first approved product to have shown efficacy for the treatment of FD under the Rome III diagnostic criteria. Rome III is the latest version of the international classification and diagnostic criteria for functional gastrointestinal disorders.
The regulatory application, which was submitted to the MHLW in Sep 2010, was based on a multicenter, randomized, double-blind, parallel-group and placebo-controlled phase III clinical study. The results showed statistically significant data when compared to placebo, in both primary endpoints and several secondary endpoints.
Astellas’ financial outlook for the current fiscal year remains unchanged.
Meanwhile, Astellas is looking to get prostate cancer candidate, Xtandi (enzalutamide), approved in Japan. Last month, Astellas had announced the submission of a marketing authorization application (MAA) in Japan for Xtandi. The submission was based on results from the phase III AFFIRM study which showed statistically significant data compared to placebo. Xtandi is already available in the US.
Astellas currently carries a Zacks Rank #4 (Sell). Currently, companies like Santarus, Inc. (SNTS), Jazz Pharmaceuticals Public Limited Company (JAZZ) and Salix Pharmaceuticals Ltd. (SLXP) look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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