Under the terms of the agreement, Lantibio will conduct the development program and filing of the new drug application (NDA), while Alcon will assume responsibility for subsequent marketing, sales and manufacturing for the US market. Terms of the agreement include up-front and development milestone payments, as well as royalties to be paid to Lantibio and TRB by Alcon on sales of the approved product.
The product consists of a TRB-patented formulation containing sodium hyaluronate and is currently being studied in the US under an investigational new drug application by a subsidiary of Lantibio. An ongoing multi-center Phase III pivotal study is being conducted under the FDA’s special protocol assessment program. Lantibio expects to file an NDA in 2008 for the product as a treatment for dry eye syndrome.
Andrew Schiermeier, CEO of Lantibio, said: “We believe this product will bring significant relief to patients with dry eye syndrome and look forward to completing our clinical study and to filing an NDA with the FDA for approval in the US.”