July 29, 2014
Bioniche Life Sciences Inc. (TSX: BNC) today announced the submission to the US Food and Drug Administration (FDA) Office of Orphan Products Development, an application for Orphan Drug Designation for its Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile suspension for the treatment of patients with Bacillus Calmette-Guérin (BCG) refractory/relapsing high grade non-muscle invasive bladder cancer.
The decision to proceed with an Orphan Drug Designation submission is part of Bioniche’s plan to move forward with the final preparation and filing of a MCNA Biological License Application (BLA) for U.S. marketing approval review as announced by the company on July 18(th) , 2014. If successful, the designation of MCNA as an Orphan Drug will provide Bioniche with a 7 year period of market exclusivity in the U.S., as well as a waiver of certain filing fees associated with a BLA, which could be in excess of $2.5 million. The review process is expected to take at least 90 days.
Dr. Michael Berendt, CEO of Bioniche Life Sciences Inc., commented: “Our Orphan Drug Designation submission, announced today, is part of our comprehensive strategy to position MCNA for therapeutic and commercial success within the Unites States. In parallel we are actively investigating our opportunities for similar development and orphan drug designation requests in other important global markets.” He continued: “I am also very pleased to report that Bioniche and its collaborators have now submitted a manuscript to a top-tier urology journal for their consideration for publication of our MCNA Phase 3 results and post-study analyses. Publishing our full MCNA Phase 3 data set will provide broad exposure of MCNA to the uro-oncology medical community, as well as potential marketing partners and will also allow full and comprehensive scientific and medical review of the MCNA clinical data results.”