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news.Nastech Pharmaceutical has reacquired the rights to Teriparatide, a parathyroid hormone nasal spray for the treatment of osteoporosis, from its collaboration partner, Procter & Gamble Pharmaceuticals. The reacquisition follows Procter & Gamble's decision to terminate the development and commercialization agreement for the nasal spray.
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Nastech will immediately advance Teriparatide (PTH1-34) nasal spray into a Phase II clinical study to evaluate the change in bone mineral density, which the FDA has previously indicated will be the primary endpoint for approval. Patient enrollment for this trial is expected in Q1 of 2008.
Steven Quay, chairman, president and CEO of Nastech, said: “Nastech’s technology enabled the delivery of a novel, patient-friendly Teriparatide nasal spray formulation that produced statistically significant changes in biomarkers of both bone growth as well as resorption. Academic experts in both nasal delivery and osteoporosis who were given the opportunity to review the data under confidentiality all came to the same conclusion, a Phase II efficacy study with bone mineral density as the endpoint is the appropriate next step in clinical development.”