Healthcare Industry News: cyclosporine
News Release - August 13, 2007
InSite Vision Announces U.S. Launch of AzaSite(TM) for Ocular Infections
ALAMEDA, Calif.--(HSMN NewsFeed)--InSite Vision Incorporated (AMEX:ISV ), an ophthalmic therapeutics, diagnostics and drug delivery company, today announced the U.S. launch and commercial availability of AzaSite(TM) (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis by Inspire Pharmaceuticals. Inspire said today that AzaSite has been shipped to pharmacies throughout the United States, and Inspire's sales force of 98 sales representatives has begun product education outreach to physicians.InSite Vision developed AzaSite by formulating azithromycin with its patented DuraSite® drug delivery vehicle and received approval from the Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis in April 2007. In February 2007, Inspire Pharmaceuticals licensed the rights from InSite Vision to commercialize AzaSite in the United States and Canada for ocular infections. InSite is entitled to receive a royalty from Inspire on net sales of AzaSite.
"We congratulate our partner Inspire Pharmaceuticals on this important step in the commercialization of AzaSite," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's chairman and chief executive officer. "Today is significant in InSite's history. We anticipate that AzaSite will become the first of multiple anti-infective therapies developed and commercialized with our DuraSite drug delivery technology."
The AzaSite anti-infective franchise includes three additional products under development. The most advanced of these, AzaSite Plus(TM), is a product candidate that combines both azithromycin and an anti-inflammatory steroid for the treatment of ocular conditions involving both bacterial infection and inflammation.
AzaSite
AzaSite offers the fewest number of doses for the treatment of bacterial conjunctivitis, commonly called "pinkeye." The recommended dose for AzaSite is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops per affected eye. The current market leader's recommended dosing regimen is one drop three times-a-day for seven days per affected eye.
"AzaSite is a welcome addition to the treatment regimen for bacterial conjunctivitis," stated Francis S. Mah, M.D., Assistant Professor of Ophthalmology and Co-medical Director, Charles T. Campbell Ophthalmic Microbiology Laboratory, University of Pittsburgh School of Medicine. "In Phase 3 clinical trials, AzaSite had excellent bacterial eradication rates against the three most common causes of bacterial conjunctivitis with tolerability similar to placebo. This, combined with a convenient dosing schedule of nine drops over the course of a week, makes AzaSite an exciting new product for both patients and parents."
"We are excited to offer patients a convenient new alternative for the treatment of bacterial conjunctivitis," stated Christy L. Shaffer, Ph.D., president and chief executive officer of Inspire. "Inspire is responsible for marketing and selling AzaSite in the United States, and we have prepared extensively for the commercial launch by building a new infrastructure to make the product available. Our sales force will be expanding on already established relationships with eye care specialists by also targeting high prescribing pediatricians and primary care physicians."
License Agreement
Under the License Agreement between InSite and Inspire, InSite granted exclusive rights to Inspire to commercialize AzaSite for ocular infection in the U.S. and Canada. In exchange, Inspire paid InSite Vision an upfront license fee of $13 million and an additional $19 million milestone payment upon FDA approval. Inspire also agreed to pay to InSite a royalty on net sales of AzaSite of 20% on net sales in the first two years of commercialization and 25% thereafter.
Important Safety Information
AzaSite(TM) (azithromycin ophthalmic solution) 1% is indicated for use in adults and children at least one year old for the treatment of bacterial conjunctivitis caused by the following organisms: CDC coryneform group G, Haemophilus influenza, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumonia. The recommended dosing regimen for the product is one drop twice-a-day for two days, followed by one drop once-a-day for the next five days, for a total of nine drops per affected eye. AzaSite should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye or otherwise administered systemically. In clinical trials, the most common adverse event in patients receiving AzaSite was eye irritation, which occurred in approximately 1-2% of patients.
About DuraSite
The DuraSite system is a patented synthetic polymer-based formulation that stabilizes small molecules, like the antibiotic azithromycin, in an aqueous matrix. DuraSite can be customized to deliver a wide variety of potential drug agents.
About Azithromycin
Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin and has been made available by Pfizer Inc. in an oral form under the trade name Zithromax® since 1992. Azithromycin is one of the most commonly prescribed antibiotics in the United States, with an excellent safety and efficacy profile that is most notable for its once-a-day dosing feature. Zithromax® is a registered trademark owned by Pfizer Inc.
About Bacterial Conjunctivitis
Bacterial conjunctivitis is a common ocular surface microbial infection characterized by inflammation of the conjunctiva, which is the mucous membrane covering the whites of the eyes and the inner side of the eyelids. The infection, which is common in children, may be contagious and generally accompanied by irritation, burning, itching, foreign body sensation, watering, mucus discharge and redness. The most common bacterial species associated with acute conjunctivitis are Haemophilus influenza, Streptococcus pneumoniae and Staphylococcus aureus.
About Inspire Pharmaceuticals
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire employs a U.S. sales force for the promotion of AzaSite (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are registered trademarks owned by Allergan Inc.
About InSite Vision Incorporated
InSite Vision develops novel ophthalmic products designed to treat a growing range of common eye problems, including ocular infection, glaucoma, and retinal disease. The Company's goal is to provide patients and physicians with improved treatment options that help preserve and improve vision worldwide.
Based on its proprietary DuraSite® drug delivery technology, InSite is creating alternative ocular anti-infective therapies, such as AzaSite(TM), AzaSite Plus(TM), and AzaSite Xtra(TM) with the potential to provide significant advantages currently not available with conventional treatment options. Additionally AzaSite Otic(TM) is being developed for ear infections.
Forward Looking Statements
This news release contains certain statements of a forward-looking nature relating to future events, such as the timing of the anticipated commercialization of AzaSite, the expected benefits of AzaSite, Inspire's sales targets and strategies, InSite's expected development and commercialization of additional anti-infective therapies using DuraSite drug delivery technology, the royalty rates expected to be received by InSite under the Inspire License Agreement, 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 ability to obtain additional funding to continue its operations; its reliance on third parties, including Inspire, for the commercialization of AzaSite and its other products; the ability of InSite Vision to enter into a corporate collaboration for AzaSite outside the U.S. and Canada and with respect to its other product candidates; the ability to commercially launch AzaSite and the timing and success of such a launch; the clinical results for InSite's product candidates; InSite Vision's ability to expand its technology platform to include additional indications; market acceptance of AzaSite; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite, 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 AzaSite Plus 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.
Source: InSite Vision
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