Inspire provided additional information to the U.S. Food and Drug
Administration (FDA) in November 2006 related to Prolacria™
(the proposed U.S. trade name for diquafosol tetrasodium ophthalmic
solution 2%). Inspire has been granted a meeting with the FDA to
continue discussions regarding Inspire's dry eye clinical program and
expects to provide an update on this program by the end of February 2007.
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®
(epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis
and Restasis®
(cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology
products developed by Allergan, Inc. Elestat and Restasis
are trademarks owned by Allergan. 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 anticipated
timing of Inspire’s update regarding the
meeting granted with the FDA with respect to Inspire’s
dry eye clinical program is a forward-looking statement 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, the seasonality of Elestat,
intellectual property rights, adverse 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, the need for additional research
and testing, delays in manufacturing, funding, and the timing and
content of decisions made by regulatory authorities, including the U.S.
Food and Drug Administration. The FDA may request that the meeting it
has granted regarding Inspire's dry eye clinical program be rescheduled.
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.
