Nastech Pharmaceutical Company has submitted an ANDA for Calcitonin Nasal Spray for osteoporosis to the FDA.

Steven C. Quay, M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech, stated, "We are pleased to have submitted the calcitonin ANDA during the fourth quarter as planned."

Calcitonin is a hormone produced by the thyroid gland that acts primarily on bone. Bone is in a constant state of remodeling, whereby old bone is removed by cells called osteoclasts, and new bone is laid down by cells called osteoblasts. Calcitonin inhibits bone removal by osteoclasts, and promotes bone formation by osteoblasts. A currently approved and marketed intranasal calcitonin has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis. Human calcitonin has a very short half-life in the blood stream and therefore the longer acting salmon calcitonin is used therapeutically.

The osteoporosis pharmaceutical market is currently $7 billion and is expected to grow to $14 billion by 2011. The only currently available formulation has worldwide sales of nearly $400 million, of which the U.S. accounts for approximately $240 million.

Nastech has developed a platform technology for delivering both small and large molecule medicines by nasal administration.