Telesta Sets Up U.S. Ops in Anticipation of Approval of Bladder Cancer Drug MCNA
September 14, 2015
By Alex Keown, BioSpace.com Breaking News Staff
MONTREAL – Telesta Therapeutics Inc. is planting a commercial sales toehold in the United States in anticipation of a regulatory approval of its bladder cancer drug MCNA in 2016, the company announced this morning.
MCNA (Mycobacterium phlei Cell Wall-Nucleic Acid Complex) is a cell wall-nucleic acid composition prepared from the fractionation of a pure culture of Mycobacterium phlei, the company said. In a late-stage clinical trial, MCNA showed an overall disease free survival rate at one year and two years was 25 percent and 19 percent, respectively.
The company is seeking regulatory approval from the U.S. Food and Drug Administration (FDA) for MCNA and hopes to begin marketing MCNA, for the treatment of high grade non-muscle invasive bladder cancer in early 2016, Michael Berendt, Telesta's chief executive officer and chief scientist, said in a statement. The company has a priority review of MCNA scheduled or Feb. 27, 2016.
Berendt said establishing a commercial sales operation in the United States will position Telesta as a “U.S. specialty pharma company.”
“We will, over the next several quarters, be working hard on multiple fronts, to continue our dialogue with the U.S. FDA around the potential approval of MCNA, to establish a lean, but efficient U.S. sales infrastructure and to identify the best path forward to add a U.S. listing for our common shares,” Berendt said. “These significant achievements and planned activities are the culmination of the systematic and successful execution of our business plan to divest our non-core assets and to become a focused human health company that delivers value to our shareholders.”
In addition to announcing its move to the U.S., Telesta announced an infusion of $28.6 million in private capital, which it is using to help set up potential marketing for MCNA. Additionally, the funding will be used, along with other capital from proceeds of a stock release, which will be used to increase spending at Telesta's manufacturing site in Montreal as the facility transitions to commercial production of MCNA.
Telesta was formerly known as Bioniche Life Sciences Inc. The company changed its name in 2014 after the company shift toward late stage human therapeutics with near-term commercial potential.
“"Our decision to implement this corporate rebranding comes on the heels of our achievements over the last 12 months to implement a concrete plan to focus our company on what we believe to be our core value driver - the commercialization of MCNA for the treatment of high-grade non-muscle invasive bladder cancer patients who have failed BCG therapy,” Berendt said at the time.
While Telesta is moving forward in anticipation of MCNA’s approval, the company announced a change in membership on the board of directors. Rod Budd resigned his position on the board in order to “ensure that his former position as a partner at Ernst and Young (where he led the Canadian biotechnology practice) did not in any way hamper” Telesta’s efforts to explore a potential U.S. stock listing due to differences between U.S. and Canadian securities laws, James Rae, the chairman of Telesta’s board of directors said in a statement.