InSite Vision Announces Court Judgment Upholding All AzaSite® Patents in Patent Infringement Lawsuit
InSite Vision Announces Court Judgment Upholding All AzaSite®Patents in Patent Infringement Lawsuit Against Sandoz Inc.
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB: INSV) today announced that the United States District Court for the District of New Jersey upheld all four of the patents protecting AzaSite® (azithromycin 1% ophthalmic solution) in a patent infringement lawsuit against Sandoz Inc.
Sandoz filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) in 2011 seeking to market a generic version of AzaSitebefore expiration of the patents covering AzaSite and its use. AzaSite is marketed by Merck (NYS: MRK) in the U.S.
In June 2013 a similar patent infringement lawsuit was filed against Mylan Pharmaceuticals. A trial date in this matter has not been set.
Mylan filed an ANDA application for AzaSite with the FDA of which InSite received notice on May 2, 2013, and InSite had 45 days to file a patent infringement lawsuit. This lawsuit triggered an automatic stay, or bar, of the FDA's approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first.
InSite owns its U.S. patents covering AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin patent.
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 Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus™ and DexaSite™ for the treatment of eye inflammation, and BromSite™ for pain and inflammation associated with ocular surgery. For further information on InSite Vision, please visit www.insitevision.com, or connect with the Company on Facebook, Twitter, LinkedIn, Google+, and SlideShare.
This news release contains certain statements of a forward looking nature relating to future events.Such statements entail a number of risks and uncertainties, including but not limited to: that the above-described decision could be appealed; that the Mylan litigation may not have a similar result; that the results of any litigation are uncertain and unpredictable; the results of clinical trials for AzaSite Plus, DexaSite and BromSite and the timing thereof, InSite's ability to obtain FDA acceptance of a New Drug Application for AzaSite Plus, DexaSite and BromSite and the timing thereof; InSite's reliance on third parties for the commercialization of its products; the ability of InSite to enter into corporate collaborations for its product candidates; InSite's ability to expand its product platform to include additional indications; InSite's ability to compete effectively, either alone or through its partners, with other companies offering competing products or treatments; InSite'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 InSite Vision'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 InSite Vision, 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 the information.Such information speaks only as of the date of its release.Actual events or results could differ materially andone should not 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™ and DexaSite™ are trademarks of InSite Vision Incorporated.
BESIVANCE® is a registered trademark of Bausch & Lomb Incorporated.
Louis Drapeau, Chief Financial Officer
Media and Investor inquiries
Karen L. Bergman
KEYWORDS: United States North America California
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