Healthcare Industry News: RESTASIS
News Release - August 13, 2007
Inspire Pharmaceuticals Launches AzaSite(TM) in the United States for Ocular Infections
DURHAM, N.C.--(HSMN NewsFeed)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH ) announced today the U.S. launch and commercial availability of AzaSite(TM)(azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis. 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.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 azithromycin ophthalmic solution formulated in DuraSite®, a patented ocular drug delivery system developed by InSite Vision Incorporated. The U.S. Food and Drug Administration (FDA) approved AzaSite for the treatment of bacterial conjunctivitis in April 2007. Inspire licensed the rights to commercialize AzaSite for ocular infections in the United States and Canada from InSite Vision in February 2007. Inspire estimates the revenues from sales of AzaSite in the United States to total $30-45 million in 2008.
"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 CEO 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."
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 influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. 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 1-2% of patients.
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 influenzae, Streptococcus pneumoniae and Staphylococcus aureus.
About Inspire
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(TM) (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCl 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. AzaSite is a trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.
Forward-Looking Statements
The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurances can be made with respect to: revenues from sales of AzaSite in 2008 or any other future period; the availability of AzaSite at any time; or the ability of Inspire's sales force to expand on already established relationships with eye care specialists or to establish relationships with pediatricians or primary care physicians. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the seasonality of Elestat, intellectual property rights, adverse litigation developments, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.
Source: Inspire Pharmaceuticals
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