InSite Vision Announces Restructuring to Support 2009 Strategic Priorities

Company Pursuing Licensing and Acquisition Opportunities for Late-Stage Ophthalmic Products

ALAMEDA, Calif.--(BUSINESS WIRE)--Mar 26, 2009 - InSite Vision Incorporated (AMEX: ISV) today announced a restructuring to support the company's focus on identifying and developing ophthalmological products for unmet eye-care needs. Earlier this month, InSite Vision outlined the company's 2009 strategic objectives to maximize shareholder value by supporting commercial product sales, partnering select pipeline assets and in-licensing or acquiring new late-stage products and technologies. Today's restructuring resulted in the elimination of 15 positions or 52 percent of the company's employees.

“InSite Vision is pursuing a strategy that leverages our current assets, including our talented ophthalmic drug development team, growing revenue from AzaSite®, several promising pipeline candidates, and our proprietary DuraSite® platform,” stated Louis Drapeau, InSite's Chief Executive Officer. “We have retained the expertise and resources necessary to capitalize on our existing portfolio and identify in-licensing or acquisition opportunities for late-stage ophthalmic products or technology platforms that will drive advanced eye-care products.”

InSite expects that the combination of this restructuring and the restructuring conducted in December 2008 will reduce its annual operating expenses by approximately $4.0 million annually. A one-time charge of approximately $0.4 million is expected to be incurred in the second quarter of 2009. Employees affected by the restructuring are eligible for a package that includes severance pay and continuation of benefits.

Among the company's top priorities is the support of continued sales growth for AzaSite (azithromycin ophthalmic solution) 1%. Since its launch in 2007, AzaSite has experienced steady quarter-over-quarter growth, reporting an increase of 54 percent in fourth quarter 2008 sales over the third quarter of 2008. AzaSite is marketed by Inspire Pharmaceuticals in the U.S., and InSite is exploring additional partnering opportunities for the product outside North America.

InSite is also exploring additional partnership opportunities to develop and commercialize products based on its DuraSite drug delivery platform. DuraSite is a synthetic polymer that stabilizes small molecules in an aqueous matrix and can be customized to deliver a wide variety of potential drug candidates. When formulated with DuraSite, typically short-acting therapeutic compounds are capable of residing on the surface of the eye for 4 to 6 hours and gradually releasing drug to ensure a therapeutic dose.

InSite's management team and Board of Directors are working closely with Piper Jaffray & Co. to identify late-stage ophthalmic product candidates, technology licensing opportunities and acquisitions to expand the company's pipeline.

About InSite Vision

InSite Vision is committed to advancing new and superior ophthalmological products for unmet eye-care needs. InSite is recognized for the discovery and development of novel ocular pharmaceutical products based on its DuraSite® bioadhesive polymer core technology, an innovative platform that extends the duration of drug delivery on the eye's surface thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. By formulating the well-established antibiotic azithromycin in DuraSite, InSite developed the lowest-dosing ocular antibiotic available to the United States ophthalmic market, AzaSite® (azithromycin ophthalmic solution) 1%. AzaSite is marketed by Inspire Pharmaceuticals in the United States for the treatment of bacterial conjunctivitis (pink eye) and has been licensed to international partners in South Korea, four countries in South America, Turkey and China for marketing and sale upon regulatory approval in those countries.

Forward Looking Statements

This news release contains certain statements of a forward-looking nature relating to future events, including the expected cost and accounting charges associated with the restructuring described herein, InSite Vision's plans to advance strategic priorities that will position the company for growth and drive value for patients and shareholders, InSite's plans to advance AzaSite and its AzaSite family of products, InSite's plans regarding further marketing and distribution of AzaSite outside its currently licensed territories, InSite's plans to acquire or in-license additional potential products, and InSite's plans for products outside of its AzaSite franchise. Such statements entail a number of risks and uncertainties, including but not limited to: InSite's reliance on third parties, including Inspire, for the commercialization of AzaSite and its other products; InSite's ability to retain Mr. Drapeau and other key management now and in the future; the ability of InSite to enter into corporate collaborations for AzaSite outside its currently licensed territories, and with respect to its other product candidates, including ISV-502; Inspire's ability to successfully market AzaSite in the United States and Canada; the ability of InSite's international partners to obtain approval to market AzaSite outside the U.S. and Canada; InSite's ability to commence clinical trials with respect to its various product candidates and the results of such trials; the clinical results of InSite's product candidates; InSite's ability to expand its technology 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;; 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. 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
Louis Drapeau, 510-747-1220
Chief Executive Officer
mail@insite.com
or
Availe Communications
Media inquiries
Ellen Rose, 650-387-8746

Posted: March 2009


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