Company Will Advance Product into Phase 2 Bone Mineral Density Study in
BOTHELL, Wash., Nov. 7 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today that it has reacquired the rights to teriparatide (Parathyroid Hormone; PTH1-34) nasal spray for the treatment of osteoporosis from its collaboration partner, Procter & Gamble Pharmaceuticals, Inc. The reacquisition follows notification on Nov. 6, 2007, of Procter & Gamble's decision to terminate the development and commercialization agreement for PTH1-34 Nasal Spray.
Nastech will immediately advance PTH1-34 Nasal Spray into a Phase 2 clinical study to evaluate the change in bone mineral density, which the FDA has previously indicated will be the primary endpoint for approval.
"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," stated Steven C. Quay, M.D., Ph.D., Chairman, President and
CEO of Nastech. "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 2 efficacy study with bone mineral
density as the endpoint is the appropriate next step in clinical
development. Although we are disappointed with P&G's decision, we remain
confident that, as the only approved anabolic drug for osteoporosis, PTH is
a very important therapeutic. Therefore, we plan to conduct a Phase 2
clinical study in patients with osteoporosis to examine the effect of
PTH1-34 Nasal Spray on bone mineral density with patient enrollm
|SOURCE Nastech Pharmaceutical Company Inc.|
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