Ipsen and Telesta Therapeutics Inc. announced yesterday that they have entered into an exclusive licensing agreement for Ipsen to develop and commercialize MCNA1 for the treatment of high risk non-muscle invasive bladder cancer (NMIBC) in all countries of the world, with the exception of the United States (because Telesta is establishing commercial operations there), Canada, South Africa, Mexico, South Korea and Japan.

The FDA has assigned priority review to Telesta’s BLA with a review (PDUFA) date of February 27, 2016. Telesta retains ownership of MCNA rights in the U.S. and Japan and will be responsible for the commercial launch of MCNA in the United States. By contrast, Ipsen will begin discussions with regulatory agencies to identify the appropriate review process and potential requirements for the product in Europe and other key licensed territories.

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