NASTECH COMPLETES FDA PAI FOR CALCITONIN-SALMON MANUFACTURE.
In June 2005, Nastech announced the successful completion of a PAI for manufacturing of calcitonin-salmon nasal spray at its Hauppauge, New York facility.
"Successful completion of the FDA Pre-Approval Inspections (PAI) at both of Nastech's manufacturing facilities is a significant achievement for the company and our partner, Par Pharmaceutical. It provides us with the capacity and flexibility necessary to meet the forecast demand for the product launch," stated David E. Wormuth, senior vice president of operations at Nastech. "Geographically separate facilities are also important to Par and our other pharmaceutical partners. This capability provides greater efficiencies in the supply and distribution of our product and enables Nastech to provide for uninterrupted supply of product."
The successful completion of the PAI marks another significant milestone in the approval process necessary to bring Nastech's calcitonin-salmon nasal spray to the market. The FDA's review of our ANDA, which included a bioequivalence study designed to demonstrate the similarity between Novartis' currently marketed calcitonin-salmon nasal spray, Miacalcin and Nastech's nasal spray product, is ongoing and must be completed prior to approval. In September 2005, a Citizens' Petition was filed with the FDA requesting that the FDA not approve any calcitonin NDA or ANDA without additional information to be submitted to the FDA. In October 2005, Nastech filed a response requesting that the FDA deny this Citizen's Petition on the grounds that no additional information is necessary from a scientific or medical perspective and that such additional information is not required under the law. Additionally, Apotex, Inc. has filed a generic application for its intranasal calcitonin-salmon product with a filing date that has priority over Nastech's ANDA for its generic calcitonin-salmon intranasal spray, which may prevent Nastech from marketing the product until 180 days after Apotex commences marketing of its product. In addition, Novartis AG has a pending patent infringement action against Apotex for its intranasal calcitonin-salmon product. At this time, Nastech is not able to determine whether or not the Citizen's Petition will delay FDA approval of Nastech's ANDA or when or how the Apotex priority will be resolved.
If approved and launched, Nastech's product will compete with the branded formulation of calcitonin-salmon nasal spray, which has annual sales in 2005 of approximately $225 million in the U.S. There are currently no generic calcitonin-salmon products on the market.
The decrease in bone mass, known as osteoporosis, in postmenopausal women is well established. Calcitonin is a hormone produced by the thyroid gland that acts primarily on bone. Bone is in a constant state of remodeling, whereby old bone is removed by cells called osteoclasts, and new bone is laid down by cells called osteoblasts. Calcitonin inhibits bone removal by osteoclasts, and promotes bone formation by osteoblasts. A currently approved and marketed intranasal calcitonin has been shown to increase spinal bone mass in postmenopausal women with established osteoporosis and is the only osteoporosis treatment specifically labeled to be used in women in whom estrogens are contraindicated. Human calcitonin has a very short half-life in the blood stream and therefore the longer acting salmon calcitonin is used therapeutically.
Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. They and their collaboration partners are developing products for multiple therapeutic areas including osteoporosis, obesity, respiratory disease and inflammatory conditions.
For more information, visit http://www.nastech.com or call 425/908-3639.
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|Date:||Apr 1, 2006|
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