- 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 Japan has granted Orphan Disease Drug Status in
Japan for 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 Japan are currently participating in the global Phase III
Confirmatory Study for KIACTA™.
"Obtaining orphan drug status in Japan is 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. Japan becomes 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 States and Orphan Medicinal Product designation in
Europe. In addition, KIACTA™ received Orphan Drug Designation in
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, Europe and 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, Europe and Japan.
SOURCE: BELLUS Health Inc.
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