BELLEVILLE, ON,
July 29, 2014 /PRNewswire/ - Bioniche
Life Sciences Inc. (TSX: BNC) today announced the submission to the
US Food and Drug Administration (FDA) Office of Orphan Products
Development, an application for Orphan Drug Designation for its
Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile
suspension for the treatment of patients with Bacillus
Calmette-Guérin (BCG) refractory/relapsing high grade non-muscle
invasive bladder cancer.
The decision to proceed with an Orphan Drug
Designation submission is part of Bioniche's plan to move forward
with the final preparation and filing of a MCNA Biological License
Application (BLA) for U.S. marketing approval review as announced
by the company on July
18th, 2014. If successful, the designation of
MCNA as an Orphan Drug will provide Bioniche with a 7 year period
of market exclusivity in the U.S., as well as a waiver of certain
filing fees associated with a BLA, which could be in excess of
$2.5 million. The review process
is expected to take at least 90 days.
Dr. Michael
Berendt, CEO of Bioniche Life Sciences Inc., commented: "Our
Orphan Drug Designation submission, announced today, is part of our
comprehensive strategy to position MCNA for therapeutic and
commercial success within the Unites States. In parallel we
are actively investigating our opportunities for similar
development and orphan drug designation requests in other important
global markets." He continued: "I am also very pleased to
report that Bioniche and its collaborators have now submitted a
manuscript to a top-tier urology journal for their consideration
for publication of our MCNA Phase 3 results and post-study
analyses. Publishing our full MCNA Phase 3 data set will provide
broad exposure of MCNA to the uro-oncology medical community, as
well as potential marketing partners and will also allow full and
comprehensive scientific and medical review of the MCNA clinical
data results."
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a clinical stage
Canadian biopharmaceutical company focused on the discovery,
development, manufacturing, and marketing of proprietary and
innovative therapies for the global human health market. The
Company's primary goal is to develop and commercialize products
that advance human health and increase shareholder value. For more
information, please visit www.Bioniche.com.
Except for historical information, this news
release may contain forward-looking statements that reflect the
Company's current expectation regarding future events. These
forward-looking statements involve risk and uncertainties, which
may cause, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties
related to the regulatory approval process, and other risks
detailed from time to time in the Company's ongoing quarterly and
annual reporting.
SOURCE Bioniche Life Sciences Inc.