Company Will Advance Product into Phase 2 Bone Mineral Density Study in 1Q08
BOTHELL, Wash., Nov. 7 /PRNewswire-FirstCall/ -- Nastech Pharmaceutical
Company Inc. (Nasdaq: NSTK) announced today that it has reacquired the rights
to teriparatide (Parathyroid Hormone; PTH1-34) nasal spray for the treatment
of osteoporosis from its collaboration partner, Procter & Gamble
Pharmaceuticals, Inc. The reacquisition follows notification on Nov. 6, 2007,
of Procter & Gamble's decision to terminate the development and
commercialization agreement for PTH1-34 Nasal Spray.
Nastech will immediately advance PTH1-34 Nasal Spray into a Phase 2
clinical study to evaluate the change in bone mineral density, which the FDA
has previously indicated will be the primary endpoint for approval.
"Nastech's technology enabled the delivery of a novel, patient-friendly
teriparatide nasal spray formulation that produced statistically significant
changes in biomarkers of both bone growth as well as resorption," stated
Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "Academic
experts in both nasal delivery and osteoporosis who were given the opportunity
to review the data under confidentiality all came to the same conclusion: A
Phase 2 efficacy study with bone mineral density as the endpoint is the
appropriate next step in clinical development. Although we are disappointed
with P&G's decision, we remain confident that, as the only approved anabolic
drug for osteoporosis, PTH is a very important therapeutic. Therefore, we
plan to conduct a Phase 2 clinical study in patients with osteoporosis to
examine the effect of PTH1-34 Nasal Spray on bone mineral density with patient
enrollment expected in the first quarter of 2008."
Nastech's pipeline, technology and opportunities remain strong with
multiple products currently in Phase 2 clinical testing. Earlier this
quarter, the company announced initiation of two phase 2 programs, one with
PYY for obesity and the other with insulin to treat type 2 diabetes.
In February 2006, Nastech and P&G entered into a development and
commercialization collaboration for teriparatide nasal spray as an
investigational product. During the collaboration, P&G completed two clinical
studies using teriparatide nasal spray: one evaluating the pharmacokinetic
profile in healthy normal subjects, and the other demonstrating the response
of bone turnover markers. These studies, in addition to the non-clinical work
completed, demonstrate that Nastech's patented nasal spray formulation
delivers teriparatide to the patient's blood, causes a response in bone
turnover markers and was well-tolerated. Nastech believes that these data
support the continued development of the product.
Nastech expects to recognize approximately $5.5 million in revenue in the
fourth quarter due to termination of the agreement.
Conference Call and Webcast Information
Nastech management will host a conference call to discuss its development
plans for teriparatide nasal spray. The call is scheduled for 8 a.m. EST/5
a.m. PST today, Wednesday, Nov. 7. To participate in the live conference
call, U.S. callers should dial (866) 510-0711, and international callers
should dial (617) 597-5379. The access code for the live conference call is
61597824. To access the 24-hour telephone replay, U.S. callers should dial
(888) 286-8010, and international callers should dial (617) 801-6888. The
access code for the replay is 80585364.
Alternatively, one can log on to http://www.nastech.com to access a live
Webcast or the subsequent 30-day archive. Please connect to the Investor
section of Nastech's Website several minutes prior to the start of the live
conference call to ensure adequate time for any software download that may be
About Teriparatide (Parathyroid Hormone; PTH1-34)
Teriparatide 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 generated $594 million in sales
Nastech is a biopharmaceutical company developing innovative products
based on proprietary molecular biology-based drug delivery technologies.
Nastech and our collaboration partners are developing products for multiple
therapeutic areas including osteoporosis, obesity, diabetes, autism,
respiratory diseases and inflammatory conditions. Additional information about
Nastech is available at http://www.nastech.com.
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.
Director, Investor Relations
Russo Partners, LLC
David Schull (Media)
SOURCE Nastech Pharmaceutical Company Inc.
CONTACT: Ed Bell, Director, Investor Relations of Nastech,
+1-425-908-3639, firstname.lastname@example.org; or Media: David Schull of Russo Partners,
LLC, +1-212-845-4271, for Nastech
Web site: http://www.nastech.com