Inspire Committed to Helping Healthcare Providers and Patients During Erythromycin Ophthalmic Ointment Shortage

• Press Release
• Source: Inspire Pharmaceuticals, Inc.
• On 4:00 pm EDT, Wednesday September 9, 2009

DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite^® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%). Erythromycin ophthalmic ointment is a macrolide antibiotic routinely used in neonates for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. If not treated, the infection can be serious and may lead to blindness. Erythromycin ophthalmic ointment was recently placed on the FDA Drug Shortages website list, which was developed to respond to drug shortages that may have a significant impact on public health¹.

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The Centers for Disease Control and Prevention (CDC), the FDA and the American Academy of Ophthalmology (AAO) have asked healthcare professionals to reserve current supplies of erythromycin ophthalmic ointment for neonatal prophylaxis use and to use alternative drugs for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin, as well as for treatment of post-surgical and post-traumatic events².

Furthermore, the CDC recommended AzaSite as an acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic ointment is not available³. The recommendation was made on the basis of available data on pharmacology and gonococcal microbiologic sensitivity. AzaSite contains azithromycin, a macrolide antibiotic, and is formulated for topical ophthalmic use; however, AzaSite has not been approved by the FDA for the treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have been conducted using AzaSite in this population.

Please refer to the CDC, FDA and AAO websites for any additional updates to their guidance.

About AzaSite^®

AzaSite^® (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis caused by the following organisms: CDC coryneform group G*, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae, and Haemophilus influenzae.

Important Safety Information: In clinical trials, the most common ocular adverse event was eye irritation, which occurred in 1% to 2% of patients. The safety and effectiveness of AzaSite in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials. Please see full Prescribing Information for AzaSite at www.azasite.com.

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire’s goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. The most advanced compounds in Inspire’s clinical pipeline are Prolacria^™ for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in Phase 3 development and AzaSite^® for blepharitis, which is in Phase 2 development. Inspire receives revenues related to the promotion of AzaSite for bacterial conjunctivitis, the co-promotion of Elestat^® for allergic conjunctivitis and royalties based on net sales of Restasis^® for dry eye. For more information, visit www.inspirepharm.com.

References

1. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM180747.pdfCDC.org.

2. http://one.aao.org/SearchResults.aspx?q=erythromycin shortage&t=o&type=0.

3. http://www.cdc.gov/std/treatment/2006/erythromycinOintmentShortage.htm.

*Efficacy for this organism was studied in fewer than 10 infections.

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. These statements are based upon the current beliefs and expectations of Inspire’s management and are subject to significant risks and uncertainties. Specifically, there can be no assurance regarding Inspire’s ability to increase production of AzaSite and the timing associated with any additional supply of AzaSite during the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%). Additionally, there can be no assurance that Inspire will be able to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. 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, intellectual property rights, 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 FDA. 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.

Inspire Pharmaceuticals, Inc.
Investor Contact:
Jenny Kobin
VP, Investor Relations and Corporate Communications
919-941-9777, ext. 219
Healthcare Providers Contact:
(888) 881-4696
or
Media Contact:
Cara Amoroso
Manager, Corporate Communications
919-941-9777, ext. 266