Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States
BELLEVILLE, ON, July 18, 2014 /PRNewswire/ - 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 data set.
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 BLA requirements.
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 markets.
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 annual reporting.
SOURCE Bioniche Life Sciences Inc.