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KIACTA(TM) Granted Orphan Drug Status in Japan
- Japanese drug development grant also received for KIACTA™ - LAVAL, QC, July 2...
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[{"type":"text","content":"\n\n\n- Japanese drug development grant also received for KIACTA™ -\n\n\nLAVAL, QC, July 23, 2013 /CNW/ - BELLUS Health Inc. (TSX: BLU) (\"BELLUS\n Health\" or the \"Company\") announced today that the Ministry of Health,\n Labour and Welfare of Japan has granted Orphan Disease Drug Status in\n Japan for KIACTA™, a novel drug candidate currently in a Phase III\n Confirmatory Study for the treatment of AA amyloidosis.\n\n\nThe Company also announced today that the National Institute of\n Biomedical Innovation (NIBIO), a Japanese government research\n organization, has granted up to the equivalent of C$500,000 towards\n KIACTA™ clinical development expenses incurred in Japan. Five clinical\n sites in Japan are currently participating in the global Phase III\n Confirmatory Study for KIACTA™.\n\n\n\"Obtaining orphan drug status in Japan is an important milestone in\n advancing the clinical and commercial strategy for KIACTA™,\" said\n Roberto Bellini, President and Chief Executive Officer of BELLUS\n Health. \"The orphan designation and grant highlight KIACTA™'s potential\n as an effective treatment for AA amyloidosis. Japan becomes the fourth\n jurisdiction where KIACTA™ has attained orphan drug designation,\n underscoring the unmet medical need for such a product and validating\n the development plan of the ongoing Phase III Confirmatory Study.\"\n\n\nKIACTA™ has previously received Orphan Disease Drug Status designation\n in the United States and Orphan Medicinal Product designation in\n Europe.  In addition, KIACTA™ received Orphan Drug Designation in\n Switzerland.\n\n\nKIACTA™ is a novel drug candidate currently in development for the\n treatment of AA amyloidosis, a condition resulting in renal dysfunction\n that often rapidly leads to dialysis and death. KIACTA™ is partnered\n with global private equity firm Auven Therapeutics. AA amyloidosis\n affects approximately 35,000 to 50,000 individuals in the United\n States, Europe and Japan.\n\n\nAs a result of the designation in Japan, KIACTA™ will receive priority\n review from Japanese regulatory authorities as a New Drug Application,\n once it is submitted. In addition, the drug will be granted 10 years of\n market exclusivity as a treatment for patients with AA amyloidosis.\n\n\nIn order ...