Telesta Therapeutics and Ipsen Announce Exclusive License Agreement

Telesta Therapeutics (TSX: TST) (PNK: BNHLF) and Ipsen (Euronext: IPN) (ADR: IPSEY) have announced an exclusive license agreement for MCNA concerning the treatment of non-muscle invasive bladder cancer.
According to the press release:

Ipsen and Telesta Therapeutics Inc. have entered into an exclusive licensing agreement for Ipsen to develop and commercialize MCNA 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, where Telesta is establishing commercial operations, Canada, South Africa, Mexico, South Korea and Japan.
Telesta recently filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for MCNA for the treatment of high risk non-muscle invasive bladder cancer patients who are refractory or relapsing from BCG front-line treatment. The FDA has assigned priority review to Telesta’s BLA with a review (PDUFA) date of February 27, 2016. Telesta retains full and sole ownership of MCNA rights in the US and Japan and will be responsible for the commercial launch of MCNA in the United States while Ipsen will initiate discussions with regulatory authorities to identify the regulatory path and potential requirements for the product in Europe and other key licensed territories.
Commenting on this partnership, Dr. Michael Berendt, Chief Executive Officer and Chief Scientistof Telesta Therapeutics noted: “Ipsen is the ideal commercial partner to bring MCNA to patients in the key pharmaceutical markets outside of the United States. They are a recognized development and commercial leader in the field of uro-oncology and are committed to collaborating with our team to ensure that MCNA is brought forward as rapidly as possible to provide a therapeutic option for this underserved patient population. Their extensive knowledge of the regulatory and commercial landscape, their commercial presence in more than 100 countries across the globe, as well as their commitment to their core urology franchise, particularly bladder cancer, is why we are convinced that they will successfully bring MCNA to urologists and their patients, outside of the United States, and generate significant value for Telesta’s shareholders.”

 
Click here to read the full press release.