InSite Vision Incorporated (AMEX:ISV) announced today that it has signed a licensing and distribution agreement with Essex Bio-Technology Limited, a leading biopharmaceutical drug development and marketing company in the People’s Republic of China, for InSite’s AzaSite® (azithromycin ophthalmic solution) 1%.
Under the terms of the agreement, InSite grants exclusive rights to Essex to commercialize AzaSite for ocular bacterial infection throughout the People’s Republic of China. Essex will also be responsible for securing and funding regulatory approval of AzaSite in China. In exchange, Essex will pay InSite up-front fees and provide a sliding royalty percentage up to double-digits on sales of AzaSite upon approval by regulatory authorities. InSite Vision will be responsible for providing manufactured product.
“We are pleased to add Essex Bio-Technology to our international licensees and distributors. Essex has been an important participant in building the growing ophthalmic market in China to be the third largest ocular anti-infective market in the world behind only the United States and Japan,” said S. Kumar Chandrasekaran, InSite Chairman and Chief Executive Officer. “We anticipate that Essex’s 200 sales representatives will provide a robust capability for penetrating the $80 million topical ophthalmic antibiotic market in China.”
Patrick Ngiam, Chairman of Essex Bio-Technology, said, “We are very pleased to be able to bring AzaSite to China. We believe AzaSite will offer a new and competitive antibiotic eye drop to the Chinese market, thus benefiting patients and partners in the distribution value chain.”
About AzaSite
AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with InSite’s proprietary 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.
AzaSite was approved in the United States for bacterial conjunctivitis (pink eye) treatment by the Food and Drug Administration (FDA) in April 2007, and was commercially launched in the United States by Inspire Pharmaceuticals, Inc. in August 2007. Inspire, a biopharmaceutical company based in Durham, North Carolina, is the exclusive licensee of AzaSite in the United States and Canada. InSite also has licensing agreements with Shin Poong for Korea, Bioceutica for Argentina, Chile, Paraguay, and Uruguay, and Biem for Turkey, and is seeking other partners for the international commercialization and distribution of AzaSite.
About DuraSite
InSite’s DuraSite drug 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. For more information about the core DuraSite drug delivery technology, visit http://www.insitevision.com/durasite.
About Essex Bio-Technology Limited
Essex is listed on the Growth Enterprise Market (GEM) of the Stock Exchange of Hong Kong, (Stock Code: 8151) and specializes in biopharmaceutical drug development based on recombinant DNA technology. Essex is principally engaged in the manufacture and sale of biopharmaceutical products for the treatment and healing of surface and eye wounds as well as other ophthalmic pharmaceutical projects, and the research and development of biopharmaceutical products for the treatment of duodenal ulcers and nervous system damages and diseases.
About InSite Vision
InSite Vision develops novel topical anti-infective products, including AzaSite. InSite is pursuing the expansion of its portfolio of anti-infective ophthalmic products to include ISV-502 in Phase 3 pivotal trials as a product candidate directed at treating eye and eye lid infections and inflammation, currently an unmet need. In addition, InSite is evaluating the use of its product platform for ear infections with the product candidate, AzaSite Otic™ in preclinical development. The company is also developing AzaSite Xtra, a product designed to assist in penetrating international markets. Additional information is available about the company at: http://www.insitevision.com.
Forward Looking Statements
This news release contains certain statements of a forward-looking nature relating to future events, such as, the potential success and market share of AzaSite in the People’s Republic of China, the potential success of Essex’s commercialization and marketing efforts, InSite’s plans with respect to commercializing AzaSite in additional countries and regions, the 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 reliance on third parties, including Inspire, Shin Poong, Bioceutica, Biem and Essex for the commercialization of AzaSite and its other products; the ability of InSite Vision to enter into additional corporate collaborations for AzaSite outside of its currently licensed territories and with respect to its other product candidates; Essex’s ability to successfully obtain approval for and market AzaSite in China and ability to successfully market AzaSite in this territory; 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, ISV-502 (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 ISV-502 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.
Contacts:
Joyce Strand, 510-747-1220
