RE:they did it ............... -- BLA for MCNA submitted electronically to the US FDA on June 29 (th), 2015 -- Manufacturing facility upgrades completed and pre-launch production planning initiated· -- FDA waives US$2.3 million application fee for Telesta
MONTREAL, June 30, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) announced today that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for MCNA(1). MCNA is Telesta's novel biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy.
Telesta also announced today that they have received from the FDA a waiver exempting Telesta from the payment of the $US2.3 million BLA application fee.
The FDA has a 60-day filing review period to determine whether Telesta's BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA's official filing communication known as the "Day-74 letter". Telesta will communicate the FDA's filing decisions upon receipt.
Telesta's BLA submission has been made following extensive and ongoing dialogue with the US FDA, including a formal pre-BLA meeting in November, 2014 and a Type C facility meeting in February, 2015. As part of this process, Telesta has incorporated the FDA's recommendations into the current submission and the Company has also been working with top tier regulatory consultants to ensure that their BLA submission meets all current regulatory requirements.
Concurrently with this BLA submission, Telesta confirmed the completion of a number of upgrades and improvements to Telesta's manufacturing facility and operating procedures, undertaken following recommendations received from the FDA at the Type C facility meeting held in February. As previously announced, these improvements were implemented by Telesta to ensure that their manufacturing facility is well positioned for the FDA pre-approval inspection that will take place as part of the FDA's formal review process.
"The BLA submission for MCNA marks an major step towards our ultimate goal of providing bladder cancer patients and the medical professionals in the urology community, with a therapeutic alternative to radical cystectomy," said Dr. Michael Berendt, CEO & Chief Scientist of Telesta Therapeutics. "There is an urgent and unmet medical need to develop new therapies for bladder cancer patients who have not seen new therapies approved for almost 20 years. I am incredibly proud of Telesta's dedicated and talented employees, many of whom have been working for more than a decade to advance this important therapeutic agent, for their hard work and professionalism that has permitted us to achieve this key corporate milestone."
Current practice guidelines for the treatment of high-risk non-muscle invasive bladder cancer patients who are refractory to or have relapsed from first line BCG therapy call for radical cystectomy (surgical removal of the bladder and adjacent organs). MCNA was developed to provide a much-needed therapeutic option for these patients. This BLA submission is the first step towards the potential regulatory approval and commercialization of MCNA, which could become the first approved therapeutic alternative for these high-risk bladder cancer patients since 1998. The approval of MCNA in the U.S. could occur as early as Q1/2016 should the FDA designate the MCNA BLA submission for priority review.