InSite Vision Announces Appeal by Sandoz Inc. of Court Judgment Upholding All AzaSite® Patents in Patent Infringement Lawsuit
InSite Vision Incorporated (OTCBB: INSV) today announced that Sandoz Inc. has filed an appeal of the court judgment that recently upheld the patents protecting AzaSite® (azithromycin 1% ophthalmic solution). The appeal was filed in the United States Court of Appeals for the Federal Circuit.
On October 7, 2013, InSite Vision announced that the United States District Court for the District of New Jersey had upheld all four of the patents protecting AzaSite in a patent infringement lawsuit against Sandoz Inc. In 2011, Sandoz filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use. AzaSite is available in the U.S. through Inspire Pharmaceuticals, a subsidiary of Merck (NYSE: MRK).
InSite owns the 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%, sold 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.
Forward-looking Statements
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 results of the appeal may not be same as the initial decision in favor of InSite and its patents; that the results of any litigation, including the Sandoz appeal, 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 and one 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.
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
InSite Vision Incorporated (OTCBB: INSV) today announced that Sandoz Inc. has filed an appeal of the court judgment that recently upheld the patents protecting AzaSite® (azithromycin 1% ophthalmic solution). The appeal was filed in the United States Court of Appeals for the Federal Circuit.
On October 7, 2013, InSite Vision announced that the United States District Court for the District of New Jersey had upheld all four of the patents protecting AzaSite in a patent infringement lawsuit against Sandoz Inc. In 2011, Sandoz filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use. AzaSite is available in the U.S. through Inspire Pharmaceuticals, a subsidiary of Merck (NYSE: MRK).
InSite owns the 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%, sold 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.
Forward-looking Statements
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 results of the appeal may not be same as the initial decision in favor of InSite and its patents; that the results of any litigation, including the Sandoz appeal, 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 and one 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.
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
