ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (AMEX:ISV - News) today announced a corporate restructuring to focus on the company’s growth opportunities and conserve resources. The restructuring will decrease the company’s personnel by approximately 35 percent. InSite expects savings from its restructuring efforts to reduce annual operating expenses by approximately $2.0 million. A one-time charge of approximately $450,000 is expected to be incurred in the fourth quarter of 2008. Employees affected by restructuring will be eligible for a severance package that includes severance pay and continuation of benefits.
“InSite Vision possesses strong core fundamentals, including a marketed product with increasing sales and significant growth potential, a promising late-stage product candidate (ISV-502), and a powerful ophthalmology drug delivery platform. Eliminating these positions, while a difficult step to take, will significantly extend our existing cash runway as we focus on supporting and growing global sales of AzaSite® and increasing value in our portfolio of new product opportunities,” stated Louis Drapeau, InSite’s Chief Executive Officer. “This restructuring is one of several steps we will take in the coming months to drive a new growth strategy that will enable us to fully realize the potential of InSite’s product portfolio and technology platform.”
The company’s marketed product, AzaSite (azithromycin ophthalmic solution) 1%, has experienced steady quarter-over-quarter growth, reporting an increase of 16 percent in third quarter 2008 sales over the second quarter of 2008; and 147 percent over the first quarter of 2008.
InSite recently announced the completion of patient dosing in the first of two pivotal Phase 3 clinical trials for ISV-502. A new topical combination antibiotic/corticosteroid agent, ISV-502 is formulated in InSite’s patented DuraSite® sustained delivery vehicle to provide simultaneous anti-infective and anti-inflammatory therapy for the treatment of lid margin disease in adults. There is no existing FDA-approved drug indicated to treat this condition.
InSite is also exploring new product opportunities based on its DuraSite drug delivery platform. DuraSite can be customized to deliver a wide variety of potential drug candidates. DuraSite is capable of residing on the surface of the eye for four to six hours and gradually releasing drug to ensure a sustained therapeutic dose.
About InSite Vision
InSite Vision develops novel ocular pharmaceutical products using its DuraSite bioadhesive polymer core technology to enable topical delivery and sustained release of existing drug molecules for reduced frequency of treatment and improved efficacy. 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%, launched by Inspire Pharmaceuticals in the United States for the treatment of bacterial conjunctivitis (pink eye). In addition, InSite has signed licensing and distribution agreements in South Korea, four countries in South America, Turkey and China. The company is seeking other international partners for commercialization and distribution of AzaSite.
InSite is pursuing the expansion of its portfolio of anti-infective ophthalmic products to include ISV-502, which is currently in Phase 3 pivotal trials for the treatment of eye and eyelid infection and inflammation, currently an unmet need. In addition, the company is investigating other product and collaboration opportunities with both the DuraSite-azithromycin platform and/or with DuraSite and other molecules.
Forward Looking Statements
This news release contains certain statements of a forward-looking nature relating to future events, including InSite Vision’s company realignment and its plans to advance strategic priorities that will position the company for growth and drive value for patients and shareholders, InSite’s plans to advance its AzaSite family of products, InSite’s plans regarding further marketing and distribution of AzaSite outside its currently licensed territories, InSite’s corporate goals, 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 identify and hire a permanent CEO and ability to retain Mr. Drapeau and other key management now and in the future; InSite’s ability to reap the benefits of its restructuring and not damage its ability to effectively purse its business plan with a reduced workforce; 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; InSite’s ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite, ISV-502, and AzaSite Xtra; 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 Investor Relations Phone: 510-747-1220 Email: mail@insite.com or Availe Communications Media Inquiries: Ellen Rose, 650-387-8746
Source: InSite Vision Incorporated
