Telesta is a late stage therapeutics company with near term commercial potential focused on a unique specialty drug (MCNA) for non-muscle invasive bladder cancer. The drug has completed a phase III study and the Company expects to file it biologics application license (BLA) with the FDA in Q2 of 2015.
Additional Highlights
The US FDA has reviewed the Company’s clinical data and is supportive of a BLA filing with no additional trials.
MCNA is a high margin biologic opportunity for Telesta that will be priced as a premium oncology product. The market size has been validated by an independent 3rd party and this market is significant.
The Company has very strong intellectual property coverage with a patent term that would expire in 2031 along with secondary protection of 12 years with US market exclusivity for novel biologic.
There has not been a new treatment for this type of cancer approved by the FDA since 1998.
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