Nastech signs PTH1-34 accord with P&G

Drug delivery specialist Nastech Pharmaceutical and fellow USA-based Procter & Gamble Pharmaceuticals have entered a development and commercialization accord on the former's parathyroid hormone (PTH1-34) nasal spray for the treatment of osteoporosis, which is about to enter Phase III development.

Under the terms of the deal, Nastech will grant P&G worldwide rights to the product, in exchange for an upfront fee, milestones and royalties on product sales. These include a $10.0 million initial payment upon execution of the agreement with the potential for additional milestones of up to $22.0 million in the first year. Nastech says it could receive as much as $577.0 million over the life of the project depending upon the successful completion of specified development, regulatory and commercialization goals. The Washington-based firm will receive double-digit royalties, with the rate escalating on the achievement of varying sales targets. No other financial terms were disclosed.

Nastech and P&G will jointly develop PTH1-34 nasal spray, and P&G will pay for any development activities and assume responsibility for clinical and non-clinical studies, as well as regulatory approval. Nastech will be responsible for the chemistry, manufacturing and controls sections of regulatory submissions. If a supply agreement is reached between the companies, Nastech will be responsible for all manufacturing of the intranasal PTH1-34 and will supply clinical and commercial product to P&G. The latter will direct worldwide sales, marketing and promotion.