InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic therapeutics, diagnostics and drug delivery company, today announced that it has entered into a worldwide, exclusive royalty bearing licensing agreement with Pfizer Inc. (NYSE:PFE) under Pfizer’s Patent family titled “Method of Treating Eye Infections with Azithromycin”. Pfizer’s granting of this license will enhance the position and marketability of InSite’s AzaSite franchise.
S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "The execution of the Pfizer license represents a significant milestone in the development of InSite Vision's AzaSite franchise. Combined with our existing azithromycin and DuraSite drug-delivery patents, this license further broadens InSite Vision's global patent portfolio.”
Under the terms of the agreement, Pfizer will grant InSite a worldwide, exclusive license, including the right to sublicense, to U.S. and all foreign counterparts patents on the parent case titled “Method of Treating Eye Infections with Azithromycin” and patent applications together with any reissues, extensions, or supplementary protection certificates of any of the foregoing for use in connection with InSite’s AzaSite franchise products.
About InSite Vision Incorporated
InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision’s lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the approval of its NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.
In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into InSite Vision’s commercially available OcuGene(R) glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.
Additional information can be found at our website, www.insitevision.com.
This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the Company's ability to obtain FDA approval of its NDA for AzaSite and the commercialization of the Company’s AzaSite product. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision’s ability to obtain substantial additional immediate funding to continue its operations; the results of InSite Vision's clinical trials; the ability to obtain FDA approval of its AzaSite NDA from the FDA for the commercialization of AzaSite and its other product candidates; the ability of InSite Vision to enter into a corporate collaboration for its AzaSite and other product candidates; the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205 as described in detail in and including the other risks described 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.
Note to Editors: OcuGene(R) is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite(R) and OcuGene(R) are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
