Inspire Initiates Phase 3 Clinical Trial of Denufosol Tetrasodium in Cystic Fibrosis Patients

The initial Phase 3 clinical trial, which will be referred to asTIGER-1 (Transport of Ions to Generate Epithelial Rehydration), isdesigned to include a 24-week efficacy treatment period, followed by a24-week safety extension period. The efficacy portion of the trial isa randomized, double-blind comparison of 60 mg of denufosol to placeboby inhalation three times daily in approximately 350 patients withmild cystic fibrosis lung disease at approximately 70 clinical centersacross the United States. The trial will enroll CF patients aged fiveyears and above. Use of standard CF therapies approved by the U.S.Food and Drug Administration (FDA), including dornase alfa,tobramycin, macrolides and digestive enzymes, will be permitted in thetrial.

For the purposes of the Phase 3 program, Inspire has defined mildcystic fibrosis lung disease as measured by the standard pulmonaryfunction test, FEV1 (Forced Expiratory Volume in one second) greaterthan or equal to 75% of predicted normal. In this trial, the primaryefficacy endpoint is change from baseline in FEV1 (liters) at the24-week time point. Secondary endpoints include other lung functionparameters, pulmonary exacerbations, requirements for concomitant CFmedications and quality of life.

"I am pleased to be working with Inspire on this novel approachfor the treatment of CF lung disease," stated Frank J. Accurso, M.D.,Professor of Pediatrics and Cystic Fibrosis Center Director,University of Colorado and The Children's Hospital Denver, and leadprincipal investigator of the trial. "The potential of denufosol as anearly-intervention therapy could be an exciting step forward in thetreatment of CF."

In cystic fibrosis, chloride builds up in cells lining the airwaysbecause the CF gene makes a faulty ion channel that does not allowchloride to exit. The result is thick, sticky mucus that leads tochronic lung infections. Denufosol tetrasodium is a selective P2Y2agonist designed to enhance the lung's innate mucosal hydration andmucociliary clearance mechanisms by activating an alternative ionchannel that acts in the same way as the defective ion channelnormally would in moving salt and water to the surface of the airways.

"This is a critical development for CF patients and couldrepresent an entirely new way to correct the basic defect in cellsthat line the airways," said Robert J. Beall, Ph.D., president and CEOof the Cystic Fibrosis Foundation. "Reaching Phase 3 is a significantachievement --for any drug -- and we look forward to the study resultsand what it could mean for CF patients' lives."

The Cystic Fibrosis Foundation has invested in the development ofthis treatment, supporting the earliest lab work in the 1990's andmore recently funding a Phase 2 trial. Denufosol was one of the firstcompounds to be studied in the CF Foundation-supported TherapeuticsDevelopment Network (TDN). The network is made up of academic medicalcenters that carry out CF clinical trials.

"We look forward to working with key experts and collaborators inthe CF field, including Dr. Accurso, the TDN, the CF Foundation andthe clinical trial sites participating in TIGER-1," stated Christy L.Shaffer, Ph.D., president and CEO of Inspire. "The initiation of thistrial represents significant progress in our CF program."

For additional information about Inspire's TIGER-1 CF trial or CFdisease, visit www.inspirepharm.com or www.cff.org.

About Denufosol Tetrasodium

Based on pre-clinical and clinical work, denufosol has severalpharmacological actions contributing to its mechanism of action:hydration of the airways by stimulating chloride and liquid secretionson the epithelial cell surface; inhibition of epithelial sodiumabsorption; enhancement of ciliary beat frequency; and stimulation ofmucin secretion. Denufosol for the treatment of cystic fibrosis hasbeen granted Fast Track designation and orphan drug status in theUnited States by the FDA and orphan drug designation in Europe by theEuropean Medicines Agency (EMEA).

About Inspire

Inspire is a biopharmaceutical company dedicated to discovering,developing and commercializing prescription pharmaceutical products indisease areas with significant commercial potential and unmet medicalneeds. The research and development programs of Inspire are driven byextensive scientific experience in the therapeutic areas ofophthalmology and respiratory/allergy, and supported by expertise inthe field of P2 receptors. Inspire is currently developing drugcandidates for dry eye, cystic fibrosis, allergic rhinitis and acutecardiac care. Inspire's U.S. specialty sales force promotes Elestat(R)(epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitisand Restasis(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye,ophthalmology products developed by Allergan, Inc. Elestat andRestasis are trademarks owned by Allergan. For more information, visitwww.inspirepharm.com.

Forward-Looking Statements

The forward-looking statements in this news release relating tomanagement's expectations and beliefs are based on preliminaryinformation and management assumptions. Such forward-lookingstatements are subject to a wide range of risks and uncertainties thatcould cause results to differ in material respects, including thoserelating to product development, revenue, expense and earningsexpectations, the seasonality of Elestat, intellectual propertyrights, adverse litigation developments, adverse developments in theU.S. Securities and Exchange Commission (SEC) investigation,competitive products, results and timing of clinical trials, successof marketing efforts, the need for additional research and testing,delays in manufacturing, funding, and the timing and content ofdecisions made by regulatory authorities, including the U.S. Food andDrug Administration. Inspire cannot guarantee the outcome or timing ofthe TIGER-1 CF trial or the Phase 3 program for denufosol for CF. Asignificant amount of work will be required to advance denufosolthrough clinical testing, including satisfactory completion ofadditional clinical trials and toxicology and carcinogenicity studies.There can be no assurance that Inspire, either alone or with thesupport of any other third party, will be able to recruit sufficientpatients for any clinical trial. The clinical trials and studies fordenufosol for CF, including the TIGER-1 trial, may not be successful.Even if such trials are successful, Inspire cannot predict when, orif, the FDA or other regulatory authorities will approve denufosol andallow its commercialization. Further information regarding factorsthat could affect Inspire's results is included in Inspire's filingswith the SEC. Inspire undertakes no obligation to publicly release theresults of any revisions to these forward-looking statements that maybe made to reflect events or circumstances after the date hereof.