MONTREAL, Nov. 5, 2014 /CNW/ - Bioniche Life Sciences Inc. (TSX: BNC) today announced that it will not continue its dialogue with the US Food & Drug Administration (FDA) concerning its request for Orphan Drug Designation (ODD) for its bladder cancer therapeutic, Mycobacterium phlei cell-wall - nucleic acid complex (MCNA). The FDA has indicated that it could not grant Bioniche's request for ODD at this time, because the Company had not established to its satisfaction that the target population estimate for MCNA did not exceed 200,000 potential patients in the US.
While the Company's internal estimates put the addressable patient population for the treatment of the bladder cancer patient subset for which it will seek label designation (high-grade non-muscle invasive bladder cancer patients who have failed BCG therapy, i.e. BCG-refractory or BCG-relapsing) at less than 10,000 patients per year, the FDA requested additional data to support that MCNA would not be efficacious in low-grade bladder cancer. Given that the Company does not have the clinical or pre-clinical data to address this assertion, it is considered more productive to move forward with other fee waiver requests.
Commenting on this decision, Dr. Michael Berendt, Bioniche CEO and Chief Scientist, noted that: "The ODD would have brought a single significant benefit to Bioniche, namely certain Biologics License Application (BLA) filing fee waivers totaling approximately $2.6 million. The other principal benefit of the designation, consisting of 7-year market exclusivity, is not required, as MCNA is a therapeutic biological product and will benefit from a longer 12-year market exclusivity upon approval, under the Patient Protection and Affordable Care Act's Biologics Price Competition and Innovation Act. My team, in anticipation of this potential decision, has made fee waiver requests under two additional separate programs and we expect to receive a positive response from one or both prior to our BLA filing, still projected in the first quarter of calendar 2015."
Bioniche would also like to remind its shareholders of its upcoming Annual General Meeting at 10 am on November 12, 2014, in Toronto, Ontario where the Company will provide a general business update. Meeting details are available in the Company's proxy circular available at www.bioniche.com or www.sedar.com.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a late clinical stage Canadian biopharmaceutical company focused on the development, manufacturing, marketing and licensing/acquisition 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" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events, including, without limitation, the proposed use of proceeds and the timing and completion of the Offering. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information 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. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements.
SOURCE: Bioniche Life Sciences Inc.
For further information:
Donald Olds, Chief Operating Officer
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058