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Inspire Licenses AzaSite(TM) For Ocular Infections.


Leverages Commercial Infrastructure with Novel Ocular Anti-Infective Product

AzaSite[TM] New Drug Application Currently Under Review by FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 with PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA)  Date in April

Conference Call Scheduled Today at 10:00 AM ET

DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ISPH ISPH Inspire Pharmaceuticals, Inc. ) announced today the signing of an exclusive licensing agreement with InSite Vision Incorporated (AMEX AMEX

See: American Stock Exchange
: ISV (Independent Software Vendor) A person or company that develops software. It implies an organization that specializes in software only and is not part of a computer systems or hardware manufacturer. ) for the U.S. and Canadian commercialization of AzaSite([TM]) (1.0% azithromycin ophthalmic solution ophthalmic solution
n.
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops.
), a topical anti-infective product currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an .

Under the terms of the agreement, Inspire has acquired from InSite Vision exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic, formulated with DuraSite([R]), InSite Vision's patented drug-delivery vehicle.

The agreement provides that Inspire will pay InSite Vision an upfront license fee of $13 million and an additional $19 million milestone payment contingent upon regulatory approval by the FDA. Inspire will also pay a royalty on net sales of AzaSite for ocular infections in the United States 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. Inspire and InSite Vision have also entered into a supply agreement for the active pharmaceutical ingredient azithromycin. In addition, Inspire has an exclusive option to negotiate a license agreement with InSite Vision for AzaSite Plus, a combination antibiotic/corticosteroid product formulated with DuraSite([R])technology.

Christy L. Shaffer, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Inspire, commented, "The addition of AzaSite to our late-stage product portfolio leverages our therapeutic focus in ophthalmology, builds on the capabilities of our commercial organization and provides a sizable near-term revenue opportunity. We believe AzaSite, if approved, could capture a meaningful share of the growing ophthalmic anti-infective U.S. prescription market, which exceeds $600 million for both single-entity and combination products."

"We look forward to the completion of the FDA's review of the AzaSite New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) by the end of April 2007, as determined by the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.  (PDUFA). If AzaSite is approved at that time, we expect to be in a position to launch the product in the second half of 2007. Following an approval, we plan to expand our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers, with the potential for additional phased-in expansion related to our other pipeline products. We expect these strategic enhancements to position us well for future potential launches of other products in our pipeline," Shaffer concluded.

Terrence P. O'Brien, M.D., Professor of Ophthalmology and Charlotte Breyer Rodgers Distinguished Chair in Ophthalmology, Bascom Palmer Eye Institute of the University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University.

The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U
, commented, "AzaSite represents an exciting new potential treatment option for external ocular infections, including bacterial conjunctivitis. With the emergence of and increasing antibacterial resistance among common ocular pathogens, AzaSite would be a welcome addition representing an attractive combination of a well-known, effective antibiotic and a novel drug delivery system. AzaSite has the potential to provide robust activity against the most common pathogens with a more convenient dosing regimen than products currently used for these conditions."

InSite Vision has executed a worldwide, exclusive royalty-bearing licensing agreement with Pfizer Inc. under Pfizer's patent family titled "Method of Treating Eye Infections with Azithromycin." Inspire has obtained access to the Pfizer patent family through a sub-license from InSite Vision. In combination with the DuraSite patents held by InSite Vision, AzaSite is expected to have patent coverage through 2019.

Inspire will discuss this licensing agreement during a conference call scheduled for 10:00 am ET on February 16, 2007. To access the conference call, U.S. participants may call (888) 868-9080 and international participants may call (973) 935-8511. The conference ID number is 8460144. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until March 2, 2007. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference ID number is 8460144.

About AzaSite[TM]

AzaSite is azithromycin 1.0% ophthalmic solution formulated in DuraSite([R]), a novel ocular drug delivery system. Two Phase 3 clinical trials have been completed in patients with bacterial conjunctivitis; one clinical trial was a vehicle-controlled trial and the second clinical trial included an active comparator comparator

Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies.
, tobramycin tobramycin /to·bra·my·cin/ (to?brah-mi´sin) an aminoglycoside antibiotic derived from a complex produced by Streptomyces tenebrarius,  ophthalmic solution. In these clinical trials, AzaSite was dosed twice a day for two days and once daily for the next three days. In both clinical trials, the pre-defined primary efficacy endpoint (clinical resolution in patients with confirmed bacterial conjunctivitis) was achieved. Clinical resolution was measured following the end of treatment and was defined as the absence of ocular discharge, bulbar bulbar /bul·bar/ (bul´ber)
1. pertaining to a bulb.

2. pertaining to or involving the medulla oblongata.


bul·bar
adj.
1. Resembling or relating to a bulb.
 conjunctival con·junc·ti·val
adj.
Relating to the conjunctiva.



conjunctival

pertaining to or emanating from conjunctiva.


congenital conjunctival membrane
 injection, and palpebral palpebral

pertaining to the eyelid.


palpebral conjunctiva
conjunctiva at the back of the eyelid.

palpebral fissure
see palpebral fissure.
 conjunctival injection. Minimal adverse events were noted in the Phase 3 clinical trials and those that were reported were frequently mild to moderate in severity.

About Azithromycin

Azithromycin is a semi-synthetic antibiotic that is derived from erythromycin erythromycin (ĭrĭth'rōmī`sĭn), any of several related antibiotic drugs produced by bacteria of the genus Streptomyces (see antibiotic).  and has been available under the trade name Zithromax[R] by Pfizer Inc. 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.

About Bacterial Conjunctivitis

Bacterial conjunctivitis is a common ocular surface microbial microbial

pertaining to or emanating from a microbe.


microbial digestion
the breakdown of organic material, especially feedstuffs, by microbial organisms.
 infection characterized by inflammation of the conjunctivae Conjunctivae
The clear membranes that line the inside of the eyelids and cover the white part (sclera) of the eyeballs.

Mentioned in: Exophthalmos, Kawasaki Syndrome
, which are the mucous membranes covering the whites of the eyes and the inner side of the eyelids eyelids,
n.pl a moveable fold of thin skin over the eye. The orbicularis oculi muscle and the oculomotor nerve control the opening and closing of the eyelid.
. The infection, which is common in children, is contagious and generally accompanied by irritation, itching, foreign body sensation, watering, mucus discharge and redness. The most common bacterial species associated with acute conjunctivitis are Hemophilus influenzae, Streptococcus streptococcus (strĕp'təkŏk`əs), any of a group of gram-positive bacteria, genus Streptococcus, some of which cause disease.  pnuemoniae, and Staphylococcus staphylococcus (stăf'ələkŏk`əs), any of the pathogenic bacteria, parasitic to humans, that belong to the genus Staphylococcus. The spherical bacterial cells (cocci) typically occur in irregular clusters [Gr.  species.

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. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis. Inspire's U.S. specialty sales force promotes Elestat([R]) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis([R]) (cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion

Sandimmun (UK), Restasis

Pharmacologic class: Polypeptide antibiotic

Therapeutic class: Immunosuppressant

Pregnancy risk category C

FDA Boxed Warning

) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. AzaSite[TM] and DuraSite([R])are trademarks owned by InSite Vision Inc. 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, the achievement and timing of regulatory review and approval by the FDA and Canadian regulatory authorities, sales estimates, the timing of a product launch, the timing and scope of an expansion to Inspire's sales and marketing force, the nature of the target physician group for the product if approved, Inspire's expectations regarding the impact of any sales force enhancement on its ability to co-promote existing products and position the Company for future potential launches of product candidates and the timing and effectiveness of patent coverage, are forward-looking statements involving risks and uncertainties. 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, adverse developments in ongoing trials, successful manufacture of any approved product, Inspire's ability to launch any product, adverse litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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, dependence on development and commercial acceptance of AzaSite, changes in the competition in the ocular infection market, general lack of experience in managed care and government contracting, the unpredictability of the duration and results of the FDA's review of regulatory submissions, changes in current and future pricing levels, changes in federal and state laws and regulations, 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. Inspire can make no assurance that the FDA or the Canadian regulatory authorities will approve AzaSite or, if approved, the timing of such approval. If AzaSite is approved, Inspire will be subject to various regulatory requirements, including requirements relating to pricing, managed care, reimbursement, rebates, adverse event reporting and manufacturing, that have not previously been applicable to Inspire. In addition, Inspire will be responsible for manufacturing, supply, labeling and distribution in relation to the product, if approved. Inspire will need to create appropriate infrastructure to meet these regulatory and business requirements. If AzaSite is approved, Inspire expects to market the product to primary care physicians, which Inspire has not previously done. There is significant competition amongst biotechnology and pharmaceutical companies for the time and attention of primary care physicians. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 16, 2007
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