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news.InSite Vision Incorporated announced that it has entered into a license agreement with Nicox, a France-based publicly traded company, for the development and commercialization of InSite’s innovative ophthalmic therapeutic products AzaSite (1% azithromycin), AzaSite Xtra (2% azithromycin) and BromSite (0.075% bromfenac) all formulated in InSite’s DuraSite® drug delivery system.
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The agreement grants Nicox exclusive rights to commercialize all three products in Europe (including Eastern Europe), Middle East and Africa (EMEA). Nicox expects to file European Marketing Authorizations (MAAs) for AzaSite and BromSite by first quarter 2016 with first commercial launch in late 2017.
"As Nicox is an emerging international ophthalmology company with an established commercial infrastructure in the main European markets, as well as a growing network of international distributors, we believe Nicox is the right strategic partner to accelerate the commercialization of our DuraSite-based products," said Timothy Ruane, InSite Vision’s Chief Executive Officer.
"This agreement allows us to bring our innovative products addressing significant eye care needs for patients in a large part of the globe."
Under terms of the licensing agreement, InSite will receive an upfront payment of $3 million and potentially $13.75 million in milestone payments. Upon product launch, InSite will also receive tiered, mid-single digit to double-digit royalties.
AzaSite is approved in the United States and Canada for the treatment of bacterial conjunctivitis, and is marketed in the U.S. by Akorn, Inc. BromSite is being developed for the treatment of inflammation and prevention of pain after cataract surgery.
Based on positive data from two pivotal Phase 3 clinical studies, InSite intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for BromSite in the first quarter of 2015. Nicox is planning to target the same ophthalmic indications in EMEA territories for AzaSite and BromSite. These products will compete in a market estimated to be more than $337 million.
The companies are evaluating the most appropriate indication and development path for AzaSite Xtra, which has completed its pre-clinical testing program in the U.S.
Nicox will manage the further development required for registration of AzaSite and BromSite in the EMEA. No further clinical studies are expected to be required prior to filing MAAs for these products in Europe.
A joint collaboration and development committee will oversee the development activities. The companies may collaborate on developing additional indications for the products.