Telesta Therapeutics Submits Biologics License Application to the U.S. FDA

MONTREAL, June 30, 2015 /PRNewswire/ --

• 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

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.

About MCNA

Telesta's MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA's pivotal Phase 3 trial were recently published in the Journal of Urology^[2] . Telesta continues to prosecute novel composition of matter, methods of use and manufacturing patents in most regions of the world and recently announced the granting of the key composition of matter patent in the United States providing intellectual property coverage of MCNA to 2031.

A recent commercial assessment, conducted by Medical Marketing Economics ("MME"), a global leader in the development of value-based strategies and market research, employed rigorous qualitative and quantitative primary market research with payers (managed care organizations/decision makers both from the private and public sector) and over 100 urologists (community urologists and key opinion leaders), to define market size, pricing strategy and market access context as well as reimbursement potential for MCNA. This study confirmed a commercial U.S. market opportunity of more than US$400 million and clearly established that the target product profile of MCNA represents an extremely interesting therapeutic option for practicing urologists.

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 http://www.telestatherapeutics.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. 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.

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1. Mycobacterium phlei cell wall-nucleic acid complex

2. Morales A, Herr H, Steinberg G, et al. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guérin. J Urol. 2015; 193: 1135-1143.

For further information:

Donald Olds, Chief Operating Officer
Telesta Therapeutics Inc.
Telephone: +1(514)-394-7921
Donald.Olds@telestatherapeutics.com

SOURCE Telesta Therapeutics Inc.