June 4, 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.
"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.
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 FEMALE SEXUAL DYSFUNCTION
According to a published survey in The Journal of the American Medical Association, four in ten American women experience some form of sexual dysfunction, a figure likely to increase as the 41 million "baby boomer" women age. Female sexual dysfunction (FSD) currently consists of four recognized components: decreased sexual desire, decreased sexual arousal, dyspareunia (painful sexual intercourse) and persistent difficulty in achieving orgasm. The causes of FSD are complicated and may include psychological problems such as depression, stress and fatigue. The intranasal apomorphine formulation under development is targeted to act on receptors in the central nervous system that may improve sexual arousal and dyspareunia.
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
1933, as amended, and Section 21E of the Securities Exchange Act of
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
made by the Company. These factors include, but are not limited to:
Company's ability to successfully complete product research and development,
including pre-clinical and clinical studies and commercialization;
Company's ability to obtain required governmental approvals, including
and patent approvals; (iii) the Company's ability to attract and/or
manufacturing, sales, distribution and marketing partners; and (iv)
Company's ability to develop and commercialize its products before
competitors. In addition, significant fluctuations in quarterly results
occur as a result of varying milestone payments and the timing of costs
expenses related to the Company's research and development program.
factors that would cause actual results to differ materially from those
projected or suggested in any forward-looking statements are contained
Company's filings with the Securities and Exchange Commission, including,
not limited to, those factors discussed under the caption "Risk Factors"
the Company's most recent Annual Report on Form 10-K and Quarterly
Form 10-Q, which the Company urges investors to consider. The Company
undertakes no obligation to publicly release the revisions to such
looking statements that may be made to reflect events or circumstances
the date hereof or to reflect the occurrences of unanticipated events,
as otherwise required by securities or other applicable laws.
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