Nastech Pharmaceutical Company Inc and Merck & Co Inc have entered into a global alliance to develop and commercialize Peptide YY 3-36 Nasal Spray (PYY), Nastech's phase I product for the treatment of obesity.
Under the terms of the agreement, Nastech will receive an initial cash payment of $5 million and will be eligible to receive up to $131 million if all development milestones and approval milestones are achieved and up to $210 million in sales-related milestones. Nastech will also receive royalties on product sales. In addition, Merck will reimburse Nastech for manufacturing-related development activities and will purchase finished product from Nastech upon commercialization. Additional financial terms were not disclosed, release from Nastech said.
Nastech and Merck will jointly develop PYY. Merck will assume primary responsibility for clinical and non-clinical studies and regulatory approval, while Nastech will be responsible for all manufacturing of PYY-related product. Merck will lead and fund commercialization, with Nastech having an option to co-promote the product in the United States.
"Nastech's innovative research and development capabilities are reflected in its rapid advancement of PYY," said Peter S Kim, president of Merck Research Laboratories. "Our alliance with Nastech recognizes the potential of PYY as a possible treatment for obesity, a disease with significant unmet medical need," he added.
"It is extremely encouraging to see groundbreaking research in obesity applied toward the development of potential treatments to target this epidemic," said Barbara Corkey, president of the North American Association for the Study of Obesity, the nation's leading scientific society dedicated to advancing research and treatment of obesity.
The investigational PYY3-36 Nasal Spray, currently in phase I development, is designed to deliver the natural, appetite-regulating hormone PYY directly to the bloodstream. Nastech has completed three Phase I clinical trials, each designed to answer specific questions regarding safety, tolerability, dosing and scheduling. Peptide YY is a naturally occurring hormone that has been implicated as a physiologic inhibitor of food intake. PYY is produced by specialized endocrine cells (L-cells) in the gut after a person eats and is believed to trigger the feeling of satiety, or fullness. Because PYY is a protein, initial studies focused on PYY delivery by injection.