BELLEVILLE, ON, July 29, 2014 /CNW/ - 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
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
SOURCE: Bioniche Life Sciences Inc.
For further information:
Donald Olds, Chief Operating Officer
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058