BOTHELL, Wash., Feb. 28 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical
Company Inc. (Nasdaq: NSTK), a leader in developing therapeutics using
advanced molecular biology-based drug delivery technologies, announced today
the successful completion of the FDA's Pre-Approval Inspection (PAI) of its
Bothell, Washington facility. Successful completion of this PAI enables
Nastech to manufacture calcitonin-salmon nasal spray for commercial use upon
FDA approval of the Company's ANDA (Abbreviated New Drug Application), which
the FDA accepted for filing in February 2004.
In June 2005, Nastech announced the successful completion of a PAI for
manufacturing of calcitonin-salmon nasal spray at its Hauppauge, New York
"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(R) 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
We are a pharmaceutical company developing innovative products based on
proprietary molecular biology-based drug delivery technologies. We and our
collaboration partners are developing products for multiple therapeutic areas
including osteoporosis, obesity, respiratory disease and inflammatory
conditions. Additional information about Nastech is available at
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements
within the meaning of Federal Securities laws that are subject to certain
risks and uncertainties and involve factors that may cause actual results to
differ materially from those projected or suggested. Factors that could cause
actual results to differ materially from those in forward-looking statements
include, but are not limited to: (i) the ability of Nastech to obtain
additional funding; (ii) the ability of Nastech to attract and/or maintain
manufacturing, research, development and commercialization partners; (iii)
Nastech's and/or a partner's ability to successfully complete product research
and development, including preclinical and clinical studies and
commercialization; (iv) Nastech's and/or a partner's ability to obtain
required governmental approvals; and (v) Nastech's and/or a partner's ability
to develop and commercialize products that can compete favorably with those of
competitors. Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking statements
are contained in Nastech's most recent periodic reports on Form 10-K and Form
10-Q that are filed with the Securities and Exchange Commission. Nastech
assumes no obligation to update and supplement forward-looking statements
because of subsequent events.
Nastech Pharmaceutical Company Inc.
Senior Investor Relations Manager
Matthew Haines (Investors/Media)
SOURCE Nastech Pharmaceutical Company Inc.
CONTACT: Nastech Pharmaceutical Company Inc. - Ed Bell, Senior Investor
Relations Manager, +1-425-908-3639, firstname.lastname@example.org; Noonan Russo - Matthew
Haines (Investors/Media), +1-212-845-4235
02/28/2006 09:00 EST http://www.prnewswire.com