BOTHELL, WA (October 25, 2004) – Nastech Pharmaceutical Co. Inc. has entered into an exclusive license and supply agreement with Par Pharmaceutical, Inc. for United States distribution and marketing of Nastech’s calcitonin-salmon nasal spray for the treatment of osteoporosis.
“This agreement has the potential to make a considerable, ongoing financial contribution to Nastech following the approval of this product,” according Dr. Steven C. Quay, chairman, president and chief executive officer of Nastech.
The collaboration combines Nastech’s abilities in preclinical and clinical productdevelopment, nasal drug formulation and delivery, and commercial-scale nasalmanufacturing with Par’s experience in the sales and marketing of generic pharmaceutical products, Nastech said.
Under the terms of the agreement, Nastech is responsible for obtaining regulatory approval and will manufacture the product in its New York and Washington facilities, providing finished calcitonin-salmon nasal spray product to Par in accordance with the license and supply agreement.
Par will exclusively market, sell and distribute the product in the U.S. market. Thefinancial terms of the agreement include an upfront payment, regulatory andpost-approval milestone payments, payments for final manufactured product, anda profit sharing arrangement following commercial launch.
In February 2004, Nastech announced that the U.S. Food & Drug Administration (FDA) accepted for filing Nastech’s Abbreviated New Drug Application (ANDA) for the product. In June, Nastech announced that the FDA had conducted a successful Pre-Approval Inspection of its calcitonin manufacturing facility with no cited deviations from current Good Manufacturing Practices.
“We look forward to working with Nastech to advance this product intocommercialization, “ said Scott Tarriff, president and chief executive officer of Par Pharmaceutical.
Novartis AG currently markets calcitonin-salmon nasal spray under the brand name Miacalcin. The product is indicated for the treatment of postmenopausal osteoporosis and aggregate pharmaceutical sales estimates for the osteoporosis market were roughly $8 billion in 2003. If successful, the Nastech product will compete with the branded formulation of calcitonin-salmon nasal spray, with current annual sales estimated at approximately $240 million in the U.S.
Par Pharmaceutical Cos., Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical,Inc., and its recently acquired subsidiary, Kali Laboratories, Inc. Thecompany is also developing an additional line of branded pharmaceuticalproducts for specialty markets and expects to introduce the first of these in2005. Par currently manufactures, markets or licenses more than 80prescription drugs.
Nastech Pharmaceutical Co. Inc. develops and commercializes drug delivery technologies and products. The company’s proprietary technologies focus onthe delivery of small and large molecule drugs by nasal administration. Nastech is developing a product portfolio across multiple therapeutic areas, including products targeted for the treatment of obesity, sexual dysfunction, pain management, and osteoporosis.