ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (AMEX:ISV - News) announced today that it has signed a licensing and distribution agreement with Biem Pharmaceuticals, an ophthalmology-focused Turkish pharmaceutical company, for InSite’s AzaSite® (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye).
Under the terms of the agreement, InSite grants exclusive rights to Biem to commercialize AzaSite for ocular bacterial infection in Turkey. An option to distribute to Biem’s export markets will be considered at a later date. Biem will be responsible for securing regulatory approval of AzaSite for the Turkish market. In exchange, Biem will pay for the cost of product registration in Turkey and provide a double-digit royalty to InSite on net sales of AzaSite upon approval by regulatory authorities. InSite Vision will be responsible for providing manufactured product.
“Biem’s established market presence and success in marketing in-licensed products will enable them to be successful with AzaSite in the growing $28 million ocular antibiotics market in Turkey,” said S. Kumar Chandrasekaran, Chairman and Chief Executive Officer of InSite Vision. “Biem represents the type of market presence and commitment necessary to assure AzaSite’s commercial success in global markets.”
“The agreement with InSite Vision fits Biem’s strategy to strengthen our existing ophthalmology healthcare portfolio. Biem has a well-established corporate image and a strong market position in this region, and AzaSite will substantially contribute to our efforts to offer differentiated therapies in the Turkish ophthalmology market segment,” said Mr. Nihat Ozen, Director of International Business and Business Development of Biem Pharmaceuticals. “We are extremely excited to begin broadening our ophthalmic business base in Turkey with an exceptional partner such as InSite Vision.”
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 has filed a New Drug Submission (NDS) with Health Canada seeking regulatory approval to market AzaSite in Canada. In addition, in December 2007, InSite signed a licensing and distribution agreement with Shin Poong Pharm in South Korea; and in March 2008 with Bioceutica to commercialize AzaSite for ocular bacterial infection in Argentina, Chile, Paraguay and Uruguay; and is seeking other international partners for 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 Biem Pharmaceuticals
Biem Pharmaceuticals, with headquarters in Ankara, is a privately held pharmaceutical marketing and distribution company focused on building a proprietary portfolio of high-value branded pharmaceutical products in Turkey and pursuing partnerships with other companies seeking to enter the Turkish pharmaceutical market. Biem Pharma aims to be the preferred partner for pharmaceutical and biotechnology companies seeking to maximize their opportunities in this territory and other selected markets. Biem is well positioned to efficiently license, register and commercialize specialty products partnering with international licensors in a wide range of therapeutic areas and market settings. Biem’s areas of interest include therapeutic solutions in ophthalmology, hematology, oncology, gynecology, radiology and neurology.
About InSite Vision
InSite Vision develops novel topical anti-infective products, including AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis (pink eye). InSite is pursuing the expansion of its portfolio of anti-infective ophthalmic products to include ISV-502 (AzaSite Plus™) in Phase 3 pivotal trials as a product candidate directed at treating eye and eye lid infections, currently an unmet need particularly prevalent among the growing elderly population. 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, an anti-infective eye 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 Turkey, the potential success of Biem’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 and Biem 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; Biem’s ability to successfully obtain approval for and market AzaSite in Turkey 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.
Contact:
InSite Vision Joyce Strand, 510-747-1220
Source: InSite Vision Incorporated
