Nastech Pharmaceutical Company Inc. said it 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 of Procter & Gamble's decision to terminate the development and commercialisation 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," said, Steven C. Quay, 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 that 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 enrolment expected in the first quarter of 2008," he added.
Nastech's pipeline, technology and opportunities remain strong with multiple products currently in phase 2 clinical testing. Earlier this quarter, the company announced initiation of two phase 2 programs, one with PYY for obesity and the other with insulin to treat type 2 diabetes.
In February 2006, Nastech and P&G entered into a development and commercialisation collaboration for teriparatide nasal spray as an investigational product. During the collaboration, P&G completed two clinical studies using teriparatide nasal spray: one evaluating the pharmacokinetic profile in healthy normal subjects, and the other demonstrating the response of bone turnover markers. These studies, in addition to the non-clinical work completed, demonstrate that Nastech's patented nasal spray formulation delivers teriparatide to the patient's blood, causes a response in bone turnover markers and was well tolerated. Nastech believes that these data support the continued development of the product.
Nastech expects to recognize approximately $5.5 million in revenue in the fourth quarter due to termination of the agreement.
Nastech is a biopharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies.