Printer Friendly
The Free Library
14,599,653 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Inspire Announces FDA Approval Of AzaSite(TM).


New Product Provides Convenient Treatment for 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  

Conference Call Scheduled for Monday, April 30, 2007 at 9:00 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 that the U.S. Food and Drug Administration (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.
) has approved AzaSite([TM]) (azithromycin ophthalmic solution ophthalmic solution
n.
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops.
) 1% for the treatment of bacterial conjunctivitis. Inspire anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 - $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans.

AzaSite will offer patients a reduced dosing regimen compared to other currently available products for bacterial conjunctivitis. The recommended dosing regimen 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 in the affected eye.

In two Phase 3 clinical studies, AzaSite met the primary efficacy endpoint of clinical resolution in patients with confirmed bacterial conjunctivitis. Clinical resolution 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. The most common adverse event in patients receiving AzaSite was eye irritation, which occurred in 1-2% of patients.

Inspire acquired exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada from InSite Vision Incorporated in February 2007. AzaSite is azithromycin ophthalmic solution formulated in DuraSite([R]), a novel ocular drug delivery system developed by InSite Vision. The product has patent coverage until 2019. Inspire will provide revised 2007 financial guidance in its first quarter 2007 financial results release on May 9th, incorporating estimated changes in 2007 revenues and expenses based on the upcoming AzaSite launch.

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 is a significant new ophthalmic product for the treatment of bacterial conjunctivitis. This unique formulation of the well-known, broad-spectrum antibiotic azithromycin results in a convenient topical dosing regimen, requiring less than half the number of drops for effective treatment compared to currently available products. These attributes are particularly important when treating young children and busy adults."

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, stated, "This is a very exciting time for Inspire as we build on our expertise in ophthalmology with the anticipated commercial launch of AzaSite. To take advantage of this opportunity, we are expanding our existing sales force to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers. This expansion will also help position us for potential future launches of products in our pipeline."

Inspire will discuss this announcement during a conference call scheduled for 9:00 a.m. ET on April 30, 2007. To access the conference call, U.S. participants may call (888) 243-6208 and international participants may call (973) 582-2869. The conference ID number is 8745321. 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 May 14, 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 8745321.

Important Safety Information

AzaSite([TM]) (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis caused by the following organisms: CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
 coryneform coryneform /co·ry·ne·form/ (-form) denoting or resembling organisms of the family Corynebacteriaceae.

coryneform

denoting or resembling organisms of the family Corynebacteriaceae. See also diphtheroid.
 group G, Staphylococcus aureus Staphylococcus au·re·us
n.
A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning.


Staphylococcus aureus Staphylococcus pyogenes
, Streptococcus mitis group, Streptococcus pneumoniae Streptococcus pneu·mo·ni·ae
n.
Pneumococcus.


Streptococcus pneumoniae Microbiology A pathogenic streptococcus with 90 serotypes associated with pneumonia, bacteremia, meningitis Transmission Person to person Incidence
, and Haemophilus influenzae. 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 erythromycin (ĭrĭth'rōmī`sĭn), any of several related antibiotic drugs produced by bacteria of the genus Streptomyces (see antibiotic).  and has been available in an oral form 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, may be 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 Haemophilus 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. Inspire employs a U.S. sales force for the promotion of AzaSite([TM] )(azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, 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. 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 trademarks owned by Allergan, Inc. AzaSite and DuraSite([R]) are trademarks 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, the timing of the AzaSite product launch, the amount of AzaSite sales in 2008, timing and scope of an expansion to Inspire's sales and marketing force, the timing of revised 2007 financial guidance and the impact of estimated changes in 2007 revenues and expenses to such guidance, the nature of the target physician group for the product, 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 duration and effectiveness of AzaSite 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 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. With respect to the approval of AzaSite, 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 and with which Inspire has limited experience. In addition, Inspire will be responsible for various matters relating to AzaSite that Inspire has not previously needed to undertake, including manufacturing, supply, labeling and distribution. Inspire will need to create appropriate infrastructure and hire appropriate personnel to meet these regulatory and business requirements. 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.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Apr 27, 2007
Words:1359
Previous Article:Sequa's Chromalloy Gas Turbine Unit Receives Major Service Agreement Award from Delta Air Lines.
Next Article:Remarks by the First Lady at the Salvation Army National Advisory Organizations Conference.
Topics:



Related Articles
Inspire Announces Receipt of FDA Approvable Letter for Diquafosol.
FDA may require more long-term data to approve psychiatric drugs.(Food and Drug Administration)(Brief Article)
Inspire Announces Outcome of FDA Meeting on Dry Eye Program; Additional Information to be Provided to FDA as Next Step.
Inspire Continues Discussions with FDA on Dry Eye Program.
Inspire Announces Dry Eye Program Update.
InSite Vision Announces License Agreement With Inspire Pharmaceuticals.
Inspire Licenses AzaSite(TM) For Ocular Infections.
InSite Vision Reports 4th Quarter and Fiscal 2006 Financial Results.(Financial report)
Inspire Announces Presentations at 2007 Association for Research in Vision and Ophthalmology Annual Meeting.
Inspire Reports First Quarter 2007 Financial Results.(Financial report)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles