BUSINESS WIRE
InSite Vision Incorporated (AMEX:ISV) announced today that it has filed a New Drug Submission (NDS) with Health Canada seeking regulatory approval to market the topical ocular antibiotic AzaSite® (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in Canada.
AzaSite was approved for bacterial conjunctivitis treatment by the United States Food and Drug Administration (FDA) in April 2007, and was commercially launched in the United States in August 2007 by Inspire Pharmaceuticals, Inc., a biopharmaceutical company based in Durham, North Carolina and AzaSite’s exclusive licensee in the United States and Canada.
“Canada is the first country outside the United States where InSite has filed for the regulatory approval of AzaSite,” said S. Kumar Chandrasekaran, Ph.D., Chief Executive Officer and President. “This second filing is an important step in AzaSite worldwide commercialization, and will enable our partner Inspire to expand sales of AzaSite beyond the borders of the United States,” Chandrasekaran concluded.
InSite has granted exclusive rights to Inspire to commercialize AzaSite for the treatment of ocular infections in the United States and Canada in exchange for milestone payments and royalties for products sold in both countries.
About AzaSite
AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with InSite’s proprietary sustained drug delivery technology (DuraSite®) as eye drops. This is the first time azithromycin has been formulated successfully for use in the eye. AzaSite offers a reduced dosing frequency as compared to currently available eye drops in the United States for the treatment of bacterial conjunctivitis and has a favorable safety and efficacy profile.
About DuraSite
InSite’s DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates.
About InSite Vision
InSite Vision develops novel topical anti-infective products, including AzaSite (azithromycin ophthalmic solution) 1% which was recently launched in the United States by Inspire Pharmaceuticals for the topical treatment of bacterial conjunctivitis (pink eye). Based on its proprietary azithromycin-DuraSite technology platform, InSite is expanding its portfolio of anti-infective ophthalmic products to include AzaSite Plus™ and AzaSite Xtra™ whose product features have the potential to provide significant advantages currently not available with conventional treatment options. In addition, InSite is evaluating the use of its azithromycin-DuraSite platform to develop topical anti-infective products outside of the market category of ophthalmology beginning with AzaSite Otic™ for ear infections.
Forward Looking Statements
This news release contains certain statements of a forward-looking nature relating to future events, such as the timing of approval of AzaSite in Canada, the expected benefits of AzaSite, InSite’s expected development and commercialization of additional anti-infective therapies using DuraSite sustained delivery technology, InSite’s corporate goals, and the proposed indications and clinical status of the company’s other product candidates. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision’s ability to obtain additional funding to continue its operations; its reliance on third parties, including Inspire, for the commercialization of AzaSite and its other products; the ability of InSite Vision to enter into a corporate collaboration for AzaSite outside the U.S. and Canada and with respect to its other product candidates; Inspire’s ability to successfully market AzaSite in the United States and Canada; the clinical results of InSite’s product candidates; InSite Vision’s ability to expand its technology platform to include additional indications; InSite Vision’s ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite, AzaSite Plus, AzaSite Xtra and AzaSite Otic; and 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, including those with respect to AzaSite Plus and AzaSite Otic. 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.