BELLEVILLE, ON, July 18, 2014 /CNW/ - Bioniche Life Sciences Inc. (TSX:
BNC) today provided a key regulatory update on its flagship Phase 3
program, Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile
suspension for the treatment of patients with Bacillus Calmette-Guérin
(BCG) refractory high grade non-muscle invasive bladder cancer.
MCNA U.S. Regulatory Update
Following several months of active dialogue with the U.S. Food and Drug
Administration (FDA), concerning the most appropriate regulatory
pathway for MCNA approval in the United States, Bioniche has received
written guidance. This guidance provides regulatory clarity and permits
the submission of an MCNA Biological License Application (BLA) for U.S.
marketing approval review based on Bioniche's existing clinical trial
In accordance with this feedback and in preparation for a timely and
efficient submission of its MCNA BLA, Bioniche has engaged a top-tier
global regulatory consulting firm that will help in the review and
final preparation of the BLA. Bioniche will provide guidance on the
anticipated timelines of this BLA submission following the completion
of a full assessment of the regulatory tasks required to complete all
Dr. Michael Berendt, CEO of Bioniche Life Sciences Inc., commented:
"This is the beginning of a new and significant transformative path for
BCG refractory bladder cancer patients as well as for Bioniche and its
shareholders. We are excited to have the opportunity to file a BLA for
MCNA based upon our existing regulatory dossier and are determined and
committed to making MCNA available to high grade non-muscle invasive
bladder cancer patients who have failed BCG treatment and who are in
dire need of treatment options beyond cystectomy." He continued: "This
significant achievement is a testament to the hard work, determination
and dedication of the committed team of people, including present and
former staff, medical professionals and others who have contributed to
advancing MCNA to this point".
Focus on Increasing Awareness of MCNA and Partnering Discussions
With regulatory clarity in hand, Bioniche is now in a position to
advance discussions with potential partners who have demonstrated a
commercial interest in MCNA for both the U.S. and other world-wide
In parallel and in further support of its MCNA partnering discussions
and so as to increase MCNA visibility within the broader urology
community, Bioniche and its collaborators have prepared a clinical
manuscript, describing MCNA Phase 3 results and post-study analyses,
that is being submitted to a top-tier urology journal.
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