BELLEVILLE, ON,
Aug. 19, 2014 /CNW/ - Bioniche Life
Sciences Inc. (TSX: BNC) today announced that it is targeting
Q1/2015 for the filing of a Biologics License Application (BLA)
with the United States Food and Drug Administration (FDA) for
Bioniche's lead program Mycobacterial Cell Wall-Nucleic Acid
Complex (MCNA) for the treatment of patients with high grade
non-muscle invasive bladder cancer that have failed Bacillus
Calmette-Guérin (BCG) therapy. This projected timeline integrates
the conclusions of a regulatory gap analysis prepared by its
consultants (reviewing the state of each BLA module and estimating
the time to complete) with the planning and scheduling of a pre-BLA
meeting between Bioniche and the FDA prior to the BLA filing.
Reporting on this analysis, Dr. Michael Berendt, Bioniche's CEO & Chief
Scientist, stated that: "Based on this preliminary, but thorough
analysis, we expect to be able to file a BLA for MCNA in the first
quarter of 2015. Prior to beginning this gap analysis, I had
asked both our regulatory consultants and clinical staff to
forecast an aggressive, but achievable timeline. Our goal will be
to try to improve on this timeline wherever possible and to ensure
that our BLA filing is comprehensive and meets all FDA
requirements. Given the importance of this filing to all of
our stakeholders, especially to bladder cancer patients who lack a
non-surgical treatment alternative, we will provide updates as we
move closer to this significant regulatory milestone.
MCNA Partnering
Bioniche has implemented a structured partnering
process for MCNA. As part of this process, Bioniche is signing
confidentiality agreements with multiple potential commercial
partners wishing to conduct due diligence and to review the
complete MCNA data package, available via our electronic data room.
In parallel, Bioniche is engaging a third party expert consulting
group to complete an independent market research and pricing/market
access assessment to validate its internal estimates, and to
provide a robust U.S. sales forecast and product valuation. This
external commercial assessment will be key in supporting the
Company through various strategic decisions, including optimizing
partnering negotiations and financial terms.
MCNA Brand Name
Bioniche has previously registered and used
Urocidin as the trade name for its bladder cancer drug.
Recent guidance issued by the U.S. FDA related to proprietary
naming regulations and requirements have made this name ineligible
for use in the Unites States. As such, the company is now
referring to the drug as MCNA and will be registering a new trade
name as it files the BLA for MCNA.
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.