Outcrop Silver & Gold Corporation press release
KIACTA(TM) Granted Orphan Drug Status in Japan
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Japanese drug development grant also received for KIACTA™ -
LAVAL, QC, July 23, 2013/CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") announced today that the Ministry of Health, Labour and Welfare of Japanhas granted Orphan Disease Drug Status in Japanfor KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis.
The Company also announced today that the National Institute of Biomedical Innovation (NIBIO), a Japanese government research organization, has granted up to the equivalent of C$500,000 towards KIACTA™ clinical development expenses incurred in Japan. Five clinical sites in Japanare currently participating in the global Phase III Confirmatory Study for KIACTA™.
"Obtaining orphan drug status in Japanis an important milestone in advancing the clinical and commercial strategy for KIACTA™," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "The orphan designation and grant highlight KIACTA™'s potential as an effective treatment for AA amyloidosis. Japanbecomes the fourth jurisdiction where KIACTA™ has attained orphan drug designation, underscoring the unmet medical need for such a product and validating the development plan of the ongoing Phase III Confirmatory Study."
KIACTA™ has previously received Orphan Disease Drug Status designation in the United Statesand Orphan Medicinal Product designation in Europe. In addition, KIACTA™ received Orphan Drug Designation in Switzerland.
KIACTA™ is a novel drug candidate currently in development for the treatment of AA amyloidosis, a condition resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europeand Japan.
As a result of the designation in Japan, KIACTA™ will receive priority review from Japanese regulatory authorities as a New Drug Application, once it is submitted. In addition, the drug will be granted 10 years of market exclusivity as a treatment for patients with AA amyloidosis.
In order to attain Orphan Disease Drug Status in Japan, a product has to meet specific criteria, namely:
There are fewer than 50,000 patients suffering from the disease There is no equivalent drug or therapy on the market or, if similar therapies exist, the efficacy of the new drug must offer significant benefits in terms of safety and/ or efficacy There must be a logical scientific basis for use of the drug There must be an appropriate development plan in place with a reasonable likelihood of success
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a development-focused healthcare company concentrating on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europeand Japan.
SOURCE: BELLUS Health Inc.
Adam Peeler TMX Equicom 416-815-0700 ext. 225 |apeeler@tmxequicom.com
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