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BELLEVILLE, ON, Aug. 19, 2014 /PRNewswire/ - 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.
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
SOURCE Bioniche Life Sciences Inc.