Inspire - Pipeline

Prolacria™ (diquafosol tetrasodium) for dry eye		Phase 3; Approvable
°	We estimate, based on an extrapolation from U.S. data, that dry eye disease affects over thirty million people in the eight major international pharmaceutical markets, of which over nine million are in North America.
°	Prolacria is being developed by Inspire as an eye drop that stimulates release of the three natural tear components involved in tear secretion - mucin, lipids and fluid.
°	To date, Inspire has completed four Phase 3 clinical trials of Prolacria for the treatment of dry eye disease. In 2003, Inspire filed an NDA with the FDA for Prolacria for the treatment of dry eye disease. Inspire has received two approvable letters from the FDA (December 2003 and December 2005).
°	Inspire initiated additional clinical work under an agreement with Ophthalmic Research Associates (ORA) to study Prolacria using ORA’s proprietary dry eye model. This includes conducting a pilot trial to determine an appropriate trial design to be used in a potential pivotal trial. Based on current plans, Inspire expects to report on the status of the dry eye program by Q3 2008.

Click here for summary of Prolacria™ clinical trials

Click here for more information about dry eye disease

P2Y RECEPTOR - A receptor is a protein molecule on the surface of a cell. Receptors attract certain types of molecules called ligands (drugs), and bind to them. This binding activates specific processes within the cell. A simple way to think of a drug binding to a receptor is the analogy of a key fitting a lock. A drug (a key) binds to a receptor (a lock) and activates (or unlocks) specific processes within the cell. Inspire's drug candidates bind to a particular type of receptor called the P2Y2 receptor (one type of P2Y receptor) and activate (or unlock) the processes of mucosal hydration and mucociliary clearance.

MUCOSAL HYDRATION - The process by which the body moistens and lubricates mucosal surfaces such as the eyes, sinuses and lungs. Specific cells on mucosal surfaces facilitate the movement of fluids (e.g., water, mucin and lipids) onto these surfaces. Proper hydration of mucosal surfaces is essential for the health of the mucosal tissues.

MUCOCILIARY CLEARANCE - The process by which mucosal surfaces such as the lungs and sinuses are cleared of particles such as dust, bacteria and viruses by the action of cilia. Cilia are small, hair-like projections that move in a waving motion to "sweep" debris away from the mucosal surface. The cilia are suspended in a layer of fluid, which allows them to move freely. Both the fluid layer and the movement (or beat) of the cilia are essential for the health of mucosal surfaces such as the lungs and sinuses.

Click here for airway surface animation/audio

ORPHAN DRUG STATUS - A category granted by the FDA for drugs to treat very rare diseases. The designation provides tax and patent incentives to drug companies that develop and market the treatment.

FAST TRACK DESIGNATION - The FDA considers Fast Track designation for products that have the potential to address unmet medical needs for serious or life-threatening conditions. Programs that have Fast Track designation may be considered for priority review or for accelerated approval based on surrogate endpoints. In addition, companies may be allowed to submit portions of an NDA early or to have early consultation with the FDA.

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Denufosol tetrasodium for cystic fibrosis (CF)		Phase 3
°	According to the CF Foundation, the median life expectancy for patients is 37 years. There are approximately 30,000 diagnosed CF patients in the U.S., included in an estimated 75,000 total in the eight major international prescription pharmaceutical markets.
°	Denufosol is designed to enhance the lung's innate mucosal hydration and mucociliary clearance through stimulation of the P2Y2 receptor.
°	Inspire has fast-track and orphan drug status for denufosol in the U.S. and orphan drug status in Europe.
°	In June 2008, Inspire announced top-line results from TIGER-1, its first Phase 3 trial with denufosol for CF. The trial demonstrated statistical significance for its primary endpoint of change in FEV1 from baseline compared to placebo (45 ml treatment group difference, p=0.047).
°	In February 2008, Inspire initiated TIGER-2, the second pivotal Phase 3 trial with denufosol. In July 2008, Inspire announced modifications to the trial’s clinical protocol.TIGER-2 is a 48-week randomized, double-blind comparison of 60 mg of denufosol to placebo in approximately 450 subjects with mild CF lung disease (FEV1 > 75% and < 110%).
°	In November 2006, Inspire initiated a required two-year inhalation carcinogenicity study in one species. The carcinogenicity final study report is expected in the second half of 2009.

Click here for summary of denufosol clinical trials

Click here for more information about cystic fibrosis

RPE - The cellular tissue that lines the back of the eye, directly behind the retina.

INTRAVITREALLY - Into the clear, jelly-like fluid that fills the back of the eye (posterior chamber) behind the lens.

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INS115644 for glaucoma		Phase 1
°	The annual U.S. market for prescription glaucoma products is approximately $1.9 billion, based on IMS date for the 12 months ended December 31, 2007.
°	In November 2004, Inspire licensed several patents for use in developing and commercializing new treatments for glaucoma from the Wisconsin Alumni Research Foundation (WARF).
°	Inspire is evaluating new and existing compounds that are active in disrupting the acto-cytoskeleton of the trabecular meshwork as potential treatments for glaucoma. The scientific hypothesis is that the mechanism of action may result in reduction of intraocular pressure by affecting the primary outflow pathway for aqueous humor.
°	Inspire is conducting a Phase 1 proof-of-concept dose-ranging clinical trial of INS115644 to evaluate the safety, tolerability and changes in intraocular pressure in glaucoma patients. Enrollment is ongoing in this clinical trial and, based upon progress to date, Inspire expects results in 2008.

Click here for Press Release on Licensing Agreement

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Forward-Looking Statements
The forward-looking statements on this website relating to management's expectations and beliefs are based on preliminary information and management assumptions. 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, adverse litigation developments, 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 United States Food and Drug Administration (FDA). Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the Securities and Exchange Commission. 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.

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Page last updated: 31-Jul-2008