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FDA Accepts ANDA Filing for Calcitonin-Salmon Nasal Spray

BOTHELL, Wash., Feb. 17 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - News) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Abbreviated New Drug Application (ANDA) for a generic Calcitonin-Salmon Nasal Spray for the treatment of osteoporosis. The osteoporosis pharmaceutical market is currently $7 billion and is expected to grow to $14 billion by 2011. According to IMS, a market research firm, worldwide sales of an existing Calcitonin-Salmon Nasal Spray were approximately $389 million in 2003, of which the U.S. accounts for an estimated $240 million.

"We are pleased with the FDA's acceptance of this ANDA filing for an important Nastech product. While we await the FDA's action, we are working to ensure that the necessary marketing and distribution arrangements are in place," stated Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech.

Calcitonin is a polypeptide hormone. Endogenous calcitonin is produced in the parafollicular cells of the thyroid gland of humans. Salmon calcitonin is 40-50 times more potent and has a longer duration of action than human calcitonin. Calcitonin prevents bone loss and fractures and increases bone density in patients with osteoporosis. Calcitonin-Salmon Nasal Spray is used for the treatment of postmenopausal osteoporosis in females and is appropriate in patients in whom estrogens are contraindicated.

Source: Nastech Pharmaceutical Company Inc.

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