Healthcare Industry News:  denufosol 

Biopharmaceuticals Ophthalmology

 News Release - December 13, 2010

Inspire Announces Launch of DIQUASTM by Santen in Japan

Inspire to Receive Milestone Payment from Santen

DURHAM, N.C.--(Healthcare Sales & Marketing Network)-- Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH ) announced that DIQUASTM Ophthalmic Solution 3% (diquafosol tetrasodium) received pricing approval and was launched for sale today in Japan by its partner, Santen Pharmaceutical Co., Ltd. Inspire will receive a related milestone payment of $1.25 million in the fourth quarter of 2010 and is also entitled to receive payments based upon a tiered royalty rate on net sales of DIQUAS in Japan, with a minimum rate in the high single digits and a maximum rate in the low double digits.

“We are pleased that DIQUAS is now available as a new treatment option for dry eye patients in Japan,” said Adrian Adams, President and CEO of Inspire. “We are completing this year with continued strong operational momentum. In addition to the DIQUAS launch and milestone payment, as a result of our prudent cash flow management throughout 2010, we recently paid off our term loan facility and expect to end the year with a strong balance sheet with no debt. This provides a solid foundation as we enter a potentially transformational year in 2011, beginning with the anticipated first quarter release of results from TIGER-2, our second Phase 3 trial of denufosol tetrasodium for cystic fibrosis.”

Pursuant to an agreement between the companies, Santen may develop and commercialize diquafosol tetrasodium for the therapeutic treatment of ocular surface diseases, such as dry eye disease, in Japan and nine other Asian countries. Diquafosol tetrasodium is currently in Phase 3 clinical testing by Santen in China.

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire’s goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. Inspire's clinical pipeline includes denufosol tetrasodium for cystic fibrosis in Phase 3 development and AZASITE® (azithromycin ophthalmic solution) 1% for blepharitis in Phase 2 development. Inspire receives revenues related to the promotion of AZASITE for bacterial conjunctivitis, the co-promotion of ELESTAT® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. 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, no assurances can be made with respect to: whether or not Santen will pay the $1.25 million milestone; the timing of the Company’s receipt of the $1.25 million milestone payment, if paid; the amount and timing of future royalty payments, if any, received by the Company relating to net sales of DIQUAS; the Company’s ability to end the year ending December 31, 2010 with a strong balance sheet with no debt; whether or not 2011 will be a transformational year for the Company; the timing or outcome of TIGER-2, the second Phase 3 trial of denufosol tetrasodium for cystic fibrosis; and the Company’s ability to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. 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 introduction of a generic form of epinastine, intellectual property rights, 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. 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.


Source: Inspire Pharmaceuticals

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