By Business Wire, October 07, 2013, 08:30:00 AM EDT
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 (NYSE: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
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,
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
Source: InSite Vision Incorporated