MONTREAL, Oct. 8, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today announced the engagement of Brian J. Groch as Chief Commercial Officer, a new executive position reflecting the company's strategic transformation to a U.S. focused specialty pharmaceutical company. As Chief Commercial Officer, Brian will be responsible for leading the development and execution of Telesta's commercial strategy beginning with the U.S. commercial launch of MCNA1 for 2nd line high risk non-muscle invasive bladder cancer, following its potential U.S. marketing approval in Q1/2016.
Brian brings more than 25 years of global commercial experience to Telesta Therapeutics, having held positions in both top-tier and start-up U.S. biopharmaceutical companies. Most recently Brian was the Vice President of Market Access at Horizon Pharma where he played a key leadership role in building Horizon's orphan commercial business capabilities after two major company acquisitions. Prior to Horizon Pharma, Brian helped build the commercial organization at Dendreon in preparation for the launch of Provenge™, successfully securing a positive national coverage decision for the first and only FDA approved immunotherapy for advanced prostate cancer. Brian is a seasoned biotechnology and pharmaceutical industry professional with broad experience in the commercial sector including multiple product launches at Novartis and Merck where he held positions in marketing, managed markets and sales leadership. Brian graduated with a B.S. in physiology and an M.S. in Business and Healthcare Administration from Central Michigan University.
Commenting on this appointment, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist declared "I am very pleased to announce this strategic appointment today. Brian's engagement as Chief Commercial Officer and his addition to our senior management team is a significant advance in our preparation for the commercial launch of MCNA in the United States. His unique experience in launch preparation, commercial operations and urology/uro-oncology will permit us to ensure a successful product launch for MCNA which could become the first new therapeutic for the treatment of high risk non-muscle invasive bladder cancer patients in decades."
MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from first line therapy with bacillus Calmette-Guérin (BCG), with a therapeutic alternative to surgery. MCNA is 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 response and safety data from MCNA's pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA's potential approval.
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.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.
1 Mycobacterium phlei cell wall-nucleic acid complex
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (514) 394-7921, [email protected]