InSite Vision Announces Settlement of Patent Infringement Lawsuit Against Mylan Pharmaceutical, Inc.

 

ALAMEDA, Calif., Mar 17, 2015 (BUSINESS WIRE) — InSite Vision Incorporated INSV today announced that it, along with other plaintiffs, has entered into a settlement agreement to dismiss a patent infringement lawsuit against Mylan Pharmaceutical, Inc. concerning Mylan’s Abbreviated New Drug Application (ANDA) seeking marketing approval from the U.S. Food and Drug Administration of a 1% azithromycin ophthalmic solution before the expiration of the patents protecting AzaSite.

Under the terms of InSite Vision’s license agreement with Akorn, Inc., the AzaSite® royalty payable to InSite Vision will increase from 8% to 9% for annual net AzaSite sales of less than $20 million. The AzaSite royalty on annual net sales between $20 million and $50 million remains at 12.5% and the royalty on annual net sales greater than $50 million remains at 15%.

AzaSite® is approved in the United States and Canada for the treatment of bacterial conjunctivitis, and is marketed by Akorn, Inc.

About InSite Vision

InSite Vision is advancing new ophthalmologic products for unmet eye care needs based on its innovative DuraSite® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing the frequency of treatment and improving the efficacy of topical drugs.

The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Akorn, Inc., and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International. InSite Vision is also advancing AzaSite Plus™, a novel ophthalmic therapeutics through Phase 3 clinical studies for the treatment of eye infections, and is preparing two new drug applications (NDA) for the commercial approval by the U.S. Food and Drug Administration (FDA): BromSite™ for the treatment of inflammation and prevention of pain associated with cataract surgery and DexaSite™ for the treatment of blepharitis. For further information on InSite Vision, please visit www.insitevision.com.

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