InSite Vision Announces Settlement Of Patent Infringement Lawsuit Against Mylan Pharmaceuticals, Inc.

ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: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.

Forward-looking Statements

This news release contains certain statements of a forward-looking nature relating to future events, including the royalty rates that may be payable to InSite for sales of AzaSite in North America:,the Company’s current plans to pursue regulatory approval for its product candidates; and the potential indications for the Company’s pipeline drug candidates. Such statements entail a number of risks and uncertainties, including but not limited to: the efforts and success of Akorn in marketing and selling AzaSite in North America, the Company’s ability to obtain substantial additional funding; the ability of the Company to file and receive approval for its BromSite NDA; the ability of the Company to enter into corporate collaborations for its product candidates; the Company’s ability to expand its product platform including AzaSite Xtra; the Company’s ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; the Company’s ability to maintain and develop additional collaborations and commercial agreements with corporate partners; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; and determinations by the FDA. Reference is made to the discussion of these and other risk factors detailed in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption “Risk Factors” and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to the Company, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update any forward-looking information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not unduly rely on such statements or information nor assume that the information provided in this release is still valid at any later date.

AzaSite^® and DuraSite^® are registered trademarks of InSite Vision Incorporated.
AzaSite Plus^™, BromSite^™, DexaSite^™ and BromDex^™ are trademarks of InSite Vision Incorporated.
Besivance^® is a registered trademark of Bausch + Lomb Incorporated.