Source: Nastech Pharmaceutical Company Inc.
Wednesday, June 04, 2003
Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK), a leader in nasal drug
delivery technology, today announced initiation of a Phase II multi-center,
double-blind, randomized, placebo-controlled, dose-ranging safety study using
its investigational intranasal apomorphine hydrochloride for treatment of male
erectile dysfunction (ED). Approximately 120 subjects ages 50 and over with or
without erectile dysfunction will be included in the study. The purpose of the
study is to investigate incremental doses of intranasal apomorphine in order
to establish the maximum tolerated safe dose and to determine specific doses
to be investigated in future clinical studies. No efficacy assessments will be
made in this study.
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"We have received a clear road map from the FDA for the development of
intranasal apomorphine for the treatment of erectile dysfunction and we are
moving the clinical trial program forward with a CRO," stated Steven C. Quay,
M.D., Ph.D., Chairman, President and Chief Executive Officer. "This
dose-ranging safety study is one of several studies designed by Nastech and
Pharmacia in accordance with our discussions with the FDA to advance the ED
program toward pivotal Phase III trials and commercialization."
Dr. Quay continued, "Intranasal apomorphine has shown promising Phase II
clinical trial results in both men and women. By working on the sexual
response centers in the brain, intranasal apomorphine represents an important
new class of drugs that are distinguished from the PDE-5 class of compounds,
which work only on the peripheral circulation. We are pleased with the
continuing progress of the intranasal apomorphine program and our ongoing
discussions with potential pharmaceutical partners. With its novel mechanism
of action and positive Phase II clinical trial data, we believe intranasal
apomorphine has the potential to be a significant competitor in the rapidly
expanding worldwide sexual dysfunction market."
In April 2003, Nastech reacquired all development and commercialization
rights for intranasal apomorphine from Pharmacia following the
Pfizer-Pharmacia merger. The divestiture was the result of the Federal Trade
Commission's (FTC) investigation of the pending merger between Pfizer and
Pharmacia. The divestiture was intended to address FTC Staff concerns that the
merger could inhibit innovation and competition in the sexual dysfunction
marketplace. Nastech is currently in discussions with certain major
pharmaceutical companies to re-partner the product for worldwide development
and commercialization.
ABOUT APOMORPHINE
Apomorphine is a potent dopamine agonist that promotes erectile function
by stimulating receptors in the hypothalamus. The PDE-5 inhibitor class of ED
therapies does not function in the brain but only on the final step in
erectile function. In addition, unlike the class of PDE-5 inhibitors that
produce hypotension, headaches, and other side effects due to non-specific
interactions in the body, apomorphine acts specifically on the D1/D2 class of
dopamine receptors that are responsible for the initiation of the erectile
response in the brain.
ABOUT ERECTILE DYSFUNCTION
ED is defined as the inability to achieve and/or maintain an erection
adequate for satisfactory sexual function. Approximately 30 million men in the
U.S. and 150 million men worldwide suffer from ED (Deutsche Banc Alex. Brown,
June 2001). The ED market is expected to have peak sales of over six billion
dollars worldwide. The condition is correlated with increasing age,
cardiovascular disease, hypertension, diabetes, hyperlipidemia and smoking. In
addition, neurogenic risk factors such as radical prostatectomy, spinal cord
injury and multiple sclerosis, certain prescription drugs, and psychogenic
issues may contribute to ED. The U.S. market for nasally administered
apomorphine for ED treatment, based on the product profile achieved in the
At-Home Phase II Study reported in December 2001, is forecast to achieve peak
sales of over $850 million (Defined Health, December 2001).
ABOUT NASTECH
Nastech Pharmaceutical Company Inc. is a formulation science company and
is recognized as a leader in nasal drug delivery technology. Formulation
science is a systematic approach to drug development using biophysics,
physical chemistry and pharmacology to maximize therapeutic efficacy and
safety, which sometimes involves a change in route of administration.
Nastech's nasal drug delivery technology is essential in designing an
optimized, customizable dosage form and in delivering proteins and
large-molecule drugs that can currently only be delivered by injection or
other non-optimized routes. Additional information about Nastech is available
at http://www.nastech.com/.
NASTECH SAFE HARBOR STATEMENT
Statements contained herein that are not historical fact may be forward-
looking statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, that are subject to a variety of risks and uncertainties. There are a
number of important factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking statement
made by the Company. These factors include, but are not limited to: (i) the
Company's ability to successfully complete product research and development,
including pre-clinical and clinical studies and commercialization; (ii) the
Company's ability to obtain required governmental approvals, including product
and patent approvals; (iii) the Company's ability to attract and/or maintain
manufacturing, sales, distribution and marketing partners; and (iv) the
Company's ability to develop and commercialize its products before its
competitors. In addition, significant fluctuations in quarterly results may
occur as a result of varying milestone payments and the timing of costs and
expenses related to the Company's research and development program. Additional
factors that would cause actual results to differ materially from those
projected or suggested in any forward-looking statements are contained in the
Company's filings with the Securities and Exchange Commission, including, but
not limited to, those factors discussed under the caption "Risk Factors" in
the Company's most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, which the Company urges investors to consider. The Company
undertakes no obligation to publicly release the revisions to such forward-
looking statements that may be made to reflect events or circumstances after
the date hereof or to reflect the occurrences of unanticipated events, except
as otherwise required by securities or other applicable laws.