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Inspire Pharma stock hits new high on FDA nod

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Inspire Pharmaceuticals Inc.’s (Nasdaq: ISPH) stock hit a new 52-week-high this morning on Friday’s news that its AzaSite treatment has received the green light from the U.S. Food and Drug Administration.

The FDA approved AzaSite, an eye-drop therapy for the treatment of bacterial conjunctivitis, Inspire announced late Friday. Bacterial conjunctivitis is more commonly known as “pink eye” in the United States.

Durham, N.C.-based Inspire said it plans to launch AzaSite in the latter part of the 2007 third quarter. It expects the drug to generate $30 million to $45 million in sales in 2008.

In light of federal approval, Inspire said it will provide revised 2007 financial guidance in its first quarter 2007 financial results release on May 9. The new results will include estimated changes in 2007 revenue and expenses based on the upcoming AzaSite launch.

In February, Inspire had estimated it would record aggregate revenue in the range of $40 million to $47 million in 2007.

Christy L. Shaffer, president and CEO of Inspire, said also that the biopharmaceutical firm will be expanding its existing sales force 50% to a total of 98 representatives who will call on targeted specialists and select pediatricians and primary care providers.

Inspire acquired exclusive rights to commercialize AzaSite for ocular infections in the United States and Canada from InSite Vision Inc. in February 2007. The product has patent coverage until 2019.

Inspire’s stock was up $0.55, or 7.5%, to $7.93 by 11:32 ET, after reaching a new 52-week-high of $8.70 earlier in the day. Previously, shares had traded between $3.92 (on June 27, 2006) and $8.29 (on Feb. 16) in the past year. Volume was 10 times more than normal – about 2.6 million shares had changed hands compared with an average three-month daily volume of 226,811 shares.