MONTREAL, Dec. 1, 2014 /CNW/ - Telesta Therapeutics Inc. (TSX: TST; PNK: BNHLF) (Formerly Bioniche Life Sciences Inc. TST:BNC) today affirmed that they remain on track with their internal objective of filing a Biologics License Application (BLA) for marketing approval with the US Food and Drug Administration (FDA) for MCNA 1 prior to March 31, 2015. Two recent key accomplishments include the completion of both a pre-BLA meeting with the US FDA and a mock-audit of Telesta's MCNA manufacturing facility. As the result of the pre-BLA meeting, Telesta received written answers and verbal feedback to a number of clinical, manufacturing and regulatory items related to the filing of their BLA while the manufacturing "mock-audit" saw a third party firm complete a detailed and exhaustive review intended to simulate the type of audit that Telesta is expected to be subject to, by the FDA, during the course of a BLA review process.
Commenting on these achievements, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted that: "We will continue to challenge ourselves and our expert consultants to ensure that the BLA that we ultimately file, will be the best BLA that we can produce. At this critical juncture in our history, nothing is more important than achieving our ultimate goal of delivering to non-muscle invasive bladder cancer patients who have failed first line BCG therapy, a new and efficacious therapeutic option."
In parallel, Telesta expects to conclude their third party assessment of the market opportunity for MCNA, in the United States, in the weeks to come. This market assessment, where qualitative and quantitative primary market research was conducted with payers (managed care organizations/decision makers both from the private and public sector) and urologists (community urologists and key opinion leaders), will address issues such as market size, pricing/pricing strategy and market access context/reimbursement potential for MCNA. These data will be key in assisting Telesta to make informed decisions concerning overall market potential and optimal licensing/partnering and/or commercial development strategy.
Telesta also announced today that its Board of Directors has accepted the resignation of Mr Greg Gubitz as a Director of the Company. Mr. James Rae, Chairman of the Board of Directors stated, "While Greg was a positive and thoughtful voice at the Board and Board committee levels, the Board must acknowledge the voting results of the November 12th, AGM. We will be conducting a search for a new Director in the weeks to come.
From today, going forward, Telesta Therapeutics will trade on the Toronto Stock Exchange (TSX) under the new ticker "TST" (TSX:TST). Telesta Therapeutics will also be announcing the launch of its new website in the weeks to come.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global 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. (www.telestatherapeutics.com is coming soon!)
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. 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.
1 Mycobacterium phlei cell wall – nucleic acid complex
SOURCE: Bioniche Life Sciences Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (613) 966-8058, [email protected]