InSite Vision Announces Joint Patent Infringement Lawsuit with Merck Against Mylan Pharmaceuticals

  InSite Vision Announces Joint Patent Infringement Lawsuit with Merck Against
  Mylan Pharmaceuticals

     Company Also Provides Update on Sandoz ANDA/Paragraph IV Trial Date

Business Wire

ALAMEDA, Calif. -- June 17, 2013

InSite Vision Incorporated (OTCBB:INSV) today announced that it will join
Merck (NYSE:MRK), known as MSD outside the United States (U.S.) and Canada,
and Pfizer Inc. (NYSE:PFE) in filing a patent infringement lawsuit against
Mylan Pharmaceuticals, Inc.

Mylan recently filed an Abbreviated New Drug Application (ANDA) with the U.S.
Food and Drug Administration (FDA) seeking to market a generic version of
AzaSite^® (azithromycin 1% ophthalmic solution) before expiration of the
patents covering AzaSite and its use. AzaSite is marketed by Merck in the U.S.
The Complaint will be filed in Federal District Court in Trenton, New Jersey.

Mylan filed an ANDA application for AzaSite with the FDA of which InSite
received notice on May 2, 2013, and InSite has 45 days to file a patent
infringement lawsuit. With this filing today, that time requirement has been
met. This lawsuit also triggers 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.

On May 26, 2011, InSite and Merck filed a similar patent infringement lawsuit
against Sandoz Inc. A trial date for the Sandoz ANDA suit has been set for
July 11, 2013. The companies have agreed that Merck will take the lead in
prosecuting both lawsuits. Each company will be responsible for their own
legal costs, with InSite assuming a monitoring role.

Merck, with the assistance of InSite and Pfizer, will vigorously defend the
five U.S. patents related to AzaSite. InSite owns four U.S. patents covering
AzaSite and its use, and an exclusive license to a Pfizer-owned azithromycin
patent. Under the license agreement between InSite and Merck, Merck has the
exclusive use of these patents in the U.S. in return for a 25 percent royalty
payable to InSite based on AzaSite net sales. InSite believes that its four
patents and the Pfizer patent were properly prosecuted with the U.S. Patent
and Trademark Office and are valid, and will provide AzaSite exclusivity until
March 2019.

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.

Forward-looking Statements

This news release contains certain statements of a forward looking nature
relating to future events, including the litigation filed against Mylan,
InSite’s and Merck’s intention to vigorously defend its patents in such
litigation, InSite’s and Merck’s current plan with respect to prosecuting the
litigation and the sharing of costs therefor, the expected trial date for the
Sandoz litigation, and the validity and term of the patents at issue. Such
statements entail a number of risks and uncertainties, including but not
limited to: patent litigation, particularly in the biotech industry, is
inherently uncertain and there can be no assurance as to how the court will
rule in this matter or that InSite and Merck will be successful, InSite and
Merck may in the future decide not to pursue such litigation or change its
strategy or change the party leading the litigation as well as the cost
sharing related thereto, the patents at issue may not be upheld as valid or
may not provide the protection or the term of protection expected, the trial
date for the Sandoz litigation may be delayed, InSite’s ability to adequately
protect its intellectual property and to be free to operate with regard to the
intellectual property of others, 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,; 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 and one should not unduly rely on such
forward-looking statements or 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.
BESIVANCE^® is a registered trademark of Bausch & Lomb Incorporated.

Contact:

InSite Vision
Louis Drapeau, 510-747-1220
Chief Financial Officer
mail@insite.com
or
Media and Investor inquiries
BCC Partners
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509
 
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