Ipsen (EPA:IPN) has picked up the rights to Telesta Therapeutics' bladder cancer drug in Europe and other ex-U.S. markets in a deal worth up to $137 million (€124 million). Having acquired the rights for $10 million upfront, Ipsen is now gearing up for talks with regulators about plotting a path to approval for the drug.
|Ipsen CEO Marc de Garidel|
Telesta has advanced the drug, MCNA, to the cusp of approval in the U.S.--it has a PDUFA review scheduled for February--but it has yet to make inroads into other markets. Paris, France-based Ipsen is coming on board to kick-start ex-U.S. development efforts. Ipsen already has a bladder cancer diagnostic, Hexvix, in its portfolio, plus ties to the broader European urology-oncology sector through its approved prostate cancer drug Decapeptyl and pipeline programs. The plan is to chat with European regulators to gauge what it will take to add MCNA to Ipsen's portfolio of approved products.
"We believe MCNA, which received priority review from FDA, is a promising second line bladder cancer treatment that would perfectly fit our urology-oncology portfolio in Europe," Ipsen CEO Marc de Garidel said in a statement. "This licensing agreement fits our business development strategy, focusing on selected niche therapeutic areas." The deal, which puts Ipsen on the hook for milestones and double-digit royalties, gives the French biopharma's urology-oncology operation another asset to develop and potentially sell. The unit was hit by the failure of tasquinimod earlier this year.
MCNA has had more success in the clinic. Telesta administered the drug, which is comprised of nucleic acids and other components of cell walls, to 129 people with non-muscle-invasive bladder cancer for whom bacillus Calmette-Guérin therapy had proven ineffective in an open-label, single-arm Phase III trial. The disease-free survival (DFS) rate was 25% after one year. By the second year, the DFS rate had ticked down to 19%. Telesta thinks the data are strong enough to secure it an approval in the U.S. early next year.
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