Healthcare Industry News: Cardinal Health
News Release - February 16, 2007
InSite Vision Announces License Agreement With Inspire Pharmaceuticals
ALAMEDA, Calif.--(HSMN NewsFeed)--InSite Vision Incorporated (AMEX:ISV ) today announced the signing of a licensing agreement with Inspire Pharmaceuticals (NASDAQ:ISPH ) for the United States and Canada. The agreement provides for the commercialization by Inspire of AzaSite(TM) (1% azithromycin), InSite's topical anti-infective product currently under NDA review by the FDA for the treatment of bacterial conjunctivitis; commonly referred to as "pink eye". The global market opportunity for topical, ocular anti-infective products currently exceeds one billion dollars.Under the terms of the agreement, InSite grants exclusive rights to Inspire to commercialize AzaSite for ocular infection in the U.S. and Canada. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite®, InSite's patented drug-delivery vehicle. If approved, it is anticipated that AzaSite will become the first ocular antibiotic with a once daily dosing regimen after an initial loading dose, which may increase patient compliance and therapeutic efficacy.
The agreement provides that Inspire Pharmaceuticals will pay InSite Vision an upfront license fee of $13 million and an additional $19 million milestone payment contingent on regulatory approval by the FDA. Inspire will also pay a royalty on net sales of AzaSite in the U.S. and Canada, if approved by regulatory authorities. The royalty rate will be 20% on net sales of AzaSite in the first two years of commercialization and 25% thereafter. InSite Vision will use a portion of the license fee to repay its senior secured notes, with a principal balance of $6.3 million, issued in December 2005 and January 2006.
S. Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer stated, "The AzaSite license agreement and related collaboration with Inspire represents the first step in realizing the global opportunity provided by our azithromycin/DuraSite drug-delivery platform. This platform will allow us to pursue additional anti-infective products and indications worldwide, supported by our expanded patent portfolio for both the AzaSite and DuraSite technologies.
"Our corporate partnership with Inspire also represents a consistent and mutually focused business strategy, designed to maximize this unique opportunity for the shareholders of both companies. We are truly delighted to be aligned with Inspire Pharmaceuticals in the pursuit of this large and attractive revenue market represented by ocular anti-infective therapies."
InSite Vision will discuss this licensing agreement during a conference call scheduled for 12:00 PM EST on February 16, 2007. To access the conference call, U.S. participants may call (877) 407-0778 and international participants may call (201) 689-8565. All callers will have to enter the account number 286 and conference ID number is 232277. A live webcast and replay of the call will be available on InSite's website at www.insitevision.com. A telephone replay of the conference call will be available until February 20, 2007 at midnight EST. To access this replay, U.S. participants may call (877) 660-6853 and international participants may call (201) 612-7415.
About Azithromycin
Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and has been available under the trade name Zithromax® (Pfizer) since 1992. Azithromycin has been the most commonly prescribed antibiotic in the United States, with an excellent safety and efficacy profile that is most notable for its once-a-day dosing feature. However, the drug had never been formulated as an ophthalmic eye drop for topical dosing because of an unfavorable stability profile.
Over the past few years, InSite Vision has been investigating ocular drug formulations that utilize DuraSite, their patented drug delivery system. DuraSite is a synthetic polymer that stabilizes small molecules like azithromycin in an aqueous matrix. A 1% solution of azithromycin in DuraSite (AzaSite) was developed and has been evaluated in Phase 3 multi-center clinical trials. The data indicates that AzaSite is a broad-spectrum antibiotic with an enhanced killing capacity for pathogens previously resistant to azithromycin, but with a safety profile that maintains many of the same well-known benefits.
About Bacterial Conjunctivitis
Bacterial conjunctivitis is a common ocular surface disease characterized by inflammation of the delicate skin and mucosa on the inside of the eyelids. The bacterial infections are contagious and generally accompanied by irritation, itching, foreign body sensation, watering, mucus discharge and redness (pink eye). The bacterial form of the disease is more common in children than adults. In children, the most common bacterial species associated with acute conjunctivitis are Hemophilus influenzae, Streptococcus pnuemoniae , and Staphylococcus species. Among adults, bacterial conjunctivitis can be an important concern in contact lens wearers. The disease is self-limiting in most cases and usually resolves in 8-10 days. Topical antibiotics are often prescribed to control the public health risk of contagion and to shorten the duration of the disease.
Clinical Trials
InSite Vision has submitted an electronic NDA filing in a modified Common Technical Document (CTD) format to the FDA for regulatory review. This submission incorporates the positive results from the recently completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing and controls. InSite previously announced the completion of these two Phase 3 studies, including a vehicle controlled study versus AzaSite, and a study comparing 0.3% tobramycin versus AzaSite. The results of these trials showed that AzaSite was safe, well tolerated and efficacious in the treatment of bacterial conjunctivitis.
The NDA submission contains data from the two Phase 3 clinical trials in which 698 patients were treated with AzaSite. Data from these studies demonstrated that when AzaSite was administered twice daily on the first two days, then once daily on days 3-5, it provided clinically and statistically significant improvements in clinical resolution of symptoms, and bacterial eradication compared to placebo, and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day.
Supply and Manufacturing
InSite Vision has signed a manufacturing supply agreement with Cardinal Health for the manufacture of topical AzaSite(TM) (1% azithromycin) commercial units. Cardinal Health manufactured the clinical trial supplies used in InSite Vision's two Phase 3 bacterial conjunctivitis clinical trials, and also the registration batches used for the AzaSite New Drug Application (NDA) filing.
About InSite Vision Incorporated
InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the approval of its NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States during 2007, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.
In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into InSite Vision's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.
Additional information can be found at our website, www.insitevision.com.
This news release and the webcast provided for hereunder contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the Company's ability to obtain FDA approval of its NDA for AzaSite, the potential benefits and indications for AzaSite, the potential market size for AzaSite, future milestone payments and royalties that may be received by the Company, the Company's product development plans and future indications for same, the timing of commercial launch of AzaSite and the Company's ability to continue its operations and fund same. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain substantial additional funding to continue its operations; the results of InSite Vision's clinical trials; the ability to obtain FDA approval of its AzaSite NDA from the FDA for the commercialization of AzaSite and its other product candidates and the timing of same; the ability of InSite Vision to maintain its collaboration with Inspire enter into a corporate collaboration for its other product candidates; Inspire's ability to successfully market AzaSite, the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications, products and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205 as described in detail in and including the other risks described 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.
Note to Editors: OcuGene® is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite® and OcuGene® are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
Source: InSite Vision
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