http://news.excite.com/news/pr/011213/ny-nastech-results
Updated: Thu, Dec 13 7:00 AM EST
HAUPPAUGE, N.Y., Dec. 13 /PRNewswire/
-- Nastech Pharmaceutical Company Inc. (NASDAQ:NSTK) reported today the
results of a Phase II clinical trial in 184 men with erectile dysfunction
(ED) that concluded its nasally administered apomorphine formulation demonstrated
excellent efficacy, was well tolerated with minimal side effects, and has
an onset of action, about 15 minutes after dosing, that uniquely matches
normal human sexual response physiology. The study supports the final stages
of the clinical development of the product and Nastech expects the pivotal
Phase III trials to begin early next year.
"These results support our belief
that nasally administered apomorphine may be an attractive alternative
to the PDE-5 inhibitor class of therapies in the treatment of erectile
dysfunction, and thus represents a significant commercial opportunity to
address the multi-billion dollar worldwide ED market," said Steven C. Quay,
M.D., Ph.D., Chairman, President and Chief Executive Officer of Nastech.
"We are currently in negotiations to complete a worldwide development and
marketing agreement for this product and we believe the results of this
study strongly support these commercialization efforts."
SITE OF ACTION
Normal human sexual response begins
with sensory input to the brain. The focus of this "central" input is the
hypothalamus, a region of the brain that, among other functions, controls
erectile function via nerves from the brain via the spinal cord to blood
vessels in the penile tissue. 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. Nastech's nasally
administered formulation is the subject of numerous patent applications
in the U.S., European Union countries, Japan, and other major countries.
TIME OF ONSET
Prior pharmacokinetic trials indicated
that nasally administered apomorphine has a maximum blood level about 15
minutes after dosing and also appears in the cerebral spinal fluid at high
levels within 20 minutes after administration. Therefore, this trial was
designed to obtain efficacy data 15 minutes after dosing. Research begun
in the 1950s by Masters and Johnson and others demonstrate that this time
of onset coincides with normal human sexual response physiology.
EFFICACY
The study involved men up to 75 years
of age with ED of all etiologies (50% psychogenic, 26% mixed organic, and
24% diabetic) and severities (64% were moderate or severe at baseline as
judged by the IIEF domain score). There were no patient restrictions as
to prior use of ED medications nor was pre-qualification with use of a
RigiScan(R) (indicative of mild erectile dysfunction) needed for inclusion
in the study. The men were randomly placed in four dosage groups: placebo,
0.25 mg, 0.50 mg, and 1.0 mg apomorphine with treatment consisting of up
to 18 doses and efficacy recorded after every administration and after
every eight doses using validated ED efficacy questionnaires. The treatment
group demographics were not different with respect to age (mean of 56 to
60 years), ethnicity, ED etiology, or ED severity.
The ability to achieve some erection
was found in 81%, 89%, and 91% of the men treated with 0.25 mg, 0.50 mg,
and 1.0 mg nasally administered apomorphine, respectively. With respect
to erections sufficient for vaginal penetration, 69%, 73%, and 82% of men
reported success in the three-apomorphine dosage groups compared to 35%
for the placebo group (1.0 mg vs. placebo, p < 0.0001). Nasally administered
apomorphine compared to placebo also demonstrated statistically significant
improvements in erectile function (including erection sufficient to complete
sexual intercourse with ejaculation), confidence in erection, orgasmic
function, and intercourse satisfaction.
SAFETY
No significant adverse events were
reported among the 184 patients enrolled in the study. Side effects were
infrequent, mild to moderate in intensity, of short duration, and resolved
without intervention. Side effects above 1% were unusual taste (5%) and
dizziness (3%). There were no reported instances of hypotension, syncope
or pre-syncopal events, including vomiting, sweating, flushing or vasodilatation,
hot flashes, or pallor.
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
here, is forecast to achieve peak sales of over $850 million (Defined Health,
December 2001). See Safe Harbor Statement below concerning these forward-looking
statements.
FEMALE SEXUAL DYSFUNCTION
In addition to developing nasally
administered apomorphine for treatment of ED, Nastech is currently conducting
a randomized, double blind, placebo-controlled Phase II clinical trial
in approximately 75 women suffering from female sexual dysfunction (FSD).
The study is designed to assess the safety and efficacy of nasally administered
apomorphine in increasing sexual satisfaction in women.
NASTECH CONFERENCE CALL AND WEBCAST
- TODAY
Management will discuss Nastech's
Phase II Apomorphine data during a conference call, which will be broadcast
live over the Internet, at 11 a.m. EST today, December 13, 2001. To access
the call, please dial: 1-800-592-3872. The reservation number is 20095307.
In conjunction with Nastech's conference call, you are invited to listen
to its conference call and view an on-line slide presentation that will
be simultaneously broadcast live over the Internet at: http://www.videonewswire.com/event.asp?id=2434
ABOUT NASTECH
Nastech Pharmaceutical Company Inc.,
recognized worldwide as a leader in nasal drug delivery technology, is
dedicated to improving patient care by using "Formulation Science," a systematic
approach to drug development using biophysics, physical chemistry, and
pharmacology to maximize therapeutic efficacy and safety, and provide new
therapeutic options. Additional information on 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 and Section 21E of the Securities
Exchange Act of 1934, that are subject to a variety of risks and uncertainties.
Total market size projections reported herein were obtained from third
parties and are forward-looking statements. Apomorphine market size projections
reported herein were contained in a study commissioned and paid for by
the Company and are forward-looking statements. Furthermore, the Company
has performed no independent verification of these forward-looking statements.
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 those factors discussed under the caption "Risk Factors" in the
Company's most recent Annual Report on Form 10-K.
Contact: Matthew D. Haines
Noonan/Russo Communications
©2001 At Home Corporation
Director, Corporate Communications
(631) 273-0101, ext. 329
(212) 696-4455
Ellie Kline, ext. 254 (media)
David Walsey, ext. 230 (investors)