Nastech Pharmaceutical Company Inc. has announced the issuance of two U.S. patents by the U.S. Patent and Trademark Office.
The patents relate to the Company's Parathyroid Hormone Nasal Spray for treatment of osteoporosis, No. 7,244,709, titled "Compositions and Methods for Enhanced Mucosal Delivery of Parathyroid Hormone," and PYY Nasal Spray for treatment of obesity, No. 7,244,412, titled "Methods for Manipulating Upper Gastrointestinal Transit, Blood Flow, and Satiety, and for Treating Visceral Hyperalgesia."
The patent for PTH Nasal Spray is directed to aqueous formulations of parathyroid hormone and excipients with a specified droplet size that prevents pulmonary exposure to the formulation, an important safety aspect of nasal spray formulation design.
The patent for PYY Nasal Spray broadly covers methods for treating obesity using PYY. The first claim of the patent states "A method for treating obesity in a mammalian subject comprising administering peptide YY to said mammal." Nastech acquired exclusive worldwide rights to this patent and other issued patents and pending applications relating to PYY from Cedars-Sinai Medical Center, Los Angeles, CA in May, 2004.
"The issuance of the first in a family of Parathyroid Hormone, PTH1-34, Nasal Spray patents as well as the issuance of an additional broad patent in the PYY Nasal Spray family of patents provide validation of our strategy and process for creating novel drug development and delivery technologies to benefit both patients and our shareholders," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "These are important achievements that help to protect the significant investment Nastech has made in the development of its formulations for PTH1-34 Nasal Spray, a non- injectable anabolic agent for the treatment of osteoporosis, and PYY Nasal Spray, a novel treatment for obesity."
PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and significantly reduce both vertebral and non-vertebral fractures in postmenopausal women. Daily injections of PTH1-34 are approved for the treatment of postmenopausal osteoporosis and had $594 million in sales during 2006. In February 2006, Nastech and Procter & Gamble entered into a development and commercialization collaboration for PTH1-34 as an investigational nasal spray.
Peptide YY is a naturally occurring hormone that is believed to function as a physiologic inhibitor of food intake. PYY is released into the blood stream from specialized endocrine cells (L-cells) in the gut after a meal and is believed to trigger the feeling of satiety, or fullness. Because PYY is a peptide, initial studies focused on PYY delivery by injection. Utilizing its proprietary drug delivery technology, Nastech developed the nasal spray formulation of PYY as a unique, non-invasive treatment option for obesity.