Inspire Pharmaceuticals to commercialize InSite Vision antibiotic if approved

Durham, NC-Inspire Pharmaceuticals plans to commercialize InSite Vision Inc.’s 1% azithromycin topical anti-infective product (AzaSite) in the United States and Canada under the terms of a licensing agreement signed by the two companies. The product is under new device application review by the FDA for the treatment of bacterial conjunctivitis.

The broad-spectrum antibiotic is formulated with InSite’s patented drug-delivery vehicle (DuraSite). If approved, it is anticipated that the product will become the first ocular antibiotic with a once-daily dosing regimen after an initial loading dose. The companies say the dosing schedule may increase patient adherence and therapeutic efficacy.

The agreement calls for Inspire to pay InSite an upfront license fee of $13 million and an additional $19 million payment contingent on regulatory approval by the FDA. Inspire also will pay a royalty-20% on net sales in the first 2 years of commercialization and 25% thereafter-on net sales of the antibiotic in the United States and Canada, if approved by regulatory authorities.

The collaboration “will allow us to pursue additional anti-infective products and indications worldwide,” said S. Kumar Chandrasekaran, PhD, chief executive officer of InSite, based in Alameda, CA.