Healthcare Industry News:  Sandoz 

Biopharmaceuticals Ophthalmology Generics Litigation

 News Release - June 17, 2013

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

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

ALAMEDA, Calif.--(Healthcare Sales & Marketing Network)--InSite Vision Incorporated (INSV) today announced that it will join Merck (MRK), known as MSD outside the United States (U.S.) and Canada, and Pfizer Inc. (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

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.

Source: InSite Vision

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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