Nastech Pharmaceutical Company Inc, of Bothell, Washington, announced the receipt of a $7 million payment for attaining a development milestone under its development and commercialization agreement with Procter & Gamble Pharmaceuticals, Inc, pertaining to parathyroid hormone (PTH1-34) nasal spray for the treatment of osteoporosis. Separately, Nastech announced that it has entered into a supply agreement with P&G wherein Nastech will be the exclusive manufacturer of the PTH1-34 nasal spray for P&G and will be responsible for the chemistry, manufacturing, and controls (CMC) sections of the US FDA regulatory submission. Nastech will manufacture the investigational product and supply it to P&G at a transfer price that includes a manufacturing profit. The specific financial terms of the agreement were not disclosed.

Recent pharmacokinetic data from a phase I study of PTH1-34 nasal spray in 12 healthy subjects demonstrated a similar pharmacokinetic profile to the approved subcutaneous product, Forteo® (teriparatide, Eli Lilly). Each subject received a single 20 ug subcutaneous injection of teriparatide followed by successive doses of an intranasal formulation of PTH1-34 to allow for pharmacokinetic comparison in the same subject. In the study, the PTH1-34 nasal spray formulations had bioavailability relative to the subcutaneous injection of up to 15 percent.

PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and significantly reduce both vertebral and nonvertebral fractures in postmenopausal women. Daily injections of PTH1-34 are approved for the treatment of postmenopausal osteoporosis. Nastech had $127 million in sales of PTH1-34 during the first quarter of 2006.

—A. Techman