Discontinuation of Development of TAK-475, a Compound for Treatment of Hypercholesterolemia
OSAKA, Japan, March 28, 2008 --- Takeda Pharmaceutical Company Limited (â€œTakedaâ€) today announced discontinuation of development of TAK-475 (lapaquistat acetate), an investigational compound studied for the treatment of hypercholesterolemia.
As announced on October 29, 2007, the Food and Drug Administration (â€œFDAâ€) in the U.S. requested additional clinical data prior to submission of a New Drug Application (â€œNDAâ€) for TAK-475 and recommended the suspension of clinical studies with higher doses.
Takeda has made the decision to discontinue development of TAK-475 based on judgment that the profile of the compound is not superior to existing marketed drugs from both efficacy and safety viewpoints. This conclusion follows a thorough review of the clinical data available to date including phase 2 clinical trial result in Japan and discussions with the relevant regulatory authorities.
Takeda will continue best efforts for the enhancement of R&D pipeline, which is one of the operational targets in "2006-2010 Medium-Term Management Planâ€, by accelerating the development projects in lifestyle-related or metabolic diseases and also in all other core therapeutic areas along with conducting in-house R&D activities, LCM, in-licensing and alliances activities.
Specifically, Takeda continues strategic investments aiming for earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the development projects in the late stage such as Hematideâ„¢, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders.
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Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.