Both clinical trials will
involve an "at home" three-month treatment period
conducted at approximately 35 clinical trial sites
throughout the United
States. The nasal formulation of PT-141 currently under development is
presented
in a convenient and non-invasive application. Clinical data indicates that PT-141
has a rapid onset
of action and may be effective in treating a broad range of
patients suffering from ED. To-date
,
the Company has formed partnerships with Mallinckrodt, a subsidiary of Tyco
Healthcare, and King
Pharmaceuticals.
discomfort revive
Carl Spana, CEO and President of
Palatin Technologies. Some important factors which
may cause results to differ materially from such forward-looking statements
include dependence
on the companies' abilities to carry out their respective
business plans; dependence on the successful
development and commercial
acceptance of PT-141; dependence on the companies' abilities to fund
development
of PT-141; dependence on whether a commercial product results from
PT-141 development activities;
dependence on the companies' abilities to
establish and successfully complete clinical trials necessary
for approval of
PT-141 as a treatment for sexual dysfunction; dependence on the actual results
of
the Phase IIb clinical program and the actual amount of time it takes to
complete the program; dependence
on the companies' abilities to successfully
collaborate in the development and commercialization
of PT-141; dependence on
the availability and cost of raw materials; dependence on the unpredictability
of the duration and results of the U. and BRISTOL, Tenn.,
Palatin Technologies, Inc.destroying viagra
After
receiving
PT-141, some patients have experienced prolonged erections lasting
over 4 hours. In addition, certain
prescription drugs and psychogenic issues
may contribute to ED.viagra impotence
Although the current ED market
is primarily served by PDE-5 inhibitors
which target the vascular system, a substantial unmet medical
need for
alternative sexual dysfunction therapies exists. Palatin's
strategy is to develop products
and then form marketing collaborations with
industry leaders in order to maximize their commercial
potential.com. Securities
and Exchange Commission.
About Palatin Technologies, Inc.
Palatin Technologies, Inc.erections discomfort
J.endure erectile
The condition is correlated with
increasing age, cardiovascular
disease, hypertension, diabetes, hyperlipidemia
and smoking. is a biopharmaceutical company developing
melanocortin-based therapeutics.medically dysfunction
Some side effects that
research participants have experienced
include facial flushing, nausea, bad
taste, post-nasal drip and runny nose, headache, and vomiting
. To date,
the Company has formed partnerships with Mallinckrodt, a subsidiary of Tyco
Healthcare
, and King Pharmaceuticals. Food and Drug Administration's ("FDA")
review of Investigational New Drug
Applications ("IND"), New Drug Applications
("NDA"), and supplemental New Drug Applications, ("sNDA
") and/or the review of
other regulatory agencies worldwide; dependence on compliance with FDA and
other government regulations that relate to King's and Palatin's respective
businesses; dependence
on King's and Palatin's abilities to successfully
manufacture PT-141; and dependence on changes in
general economic and business
conditions; changes in current pricing levels; changes in federal and
state
laws and regulations; changes in competition; unexpected changes in
technologies and technological
advances; and manufacturing capacity
constraints. CRANBURY, N. (Amex: PTNKG)
announced today
publication of the manuscript entitled "Co-administration Of
Low Doses Of Intranasal PT-141, A Melanocortin
Receptor Agonist, and
Sildenafil to Men with Erectile Dysfunction Results in an Enhanced Erectile
Response" in the April 2005 issue of the Urology journal. We anticipate that the nasal formulation
of PT-
141 currently under development will be as convenient as oral treatments and
more patient
-friendly than invasive treatments for ED, such as injections and
trans-urethral pellets.veromax discomfort
S. The mechanism
of action of PT-141 may offer
important benefits over currently available products for the treatment
of ED
because it appears to act on the pathway that controls sexual function without
acting directly
on the vascular system. The
companies do not undertake to publicly update or revise any of their
forward-
looking statements even if experience or future changes show that the
indicated results
or events will not be realized.
destroying discomfort
The Company has one product on the market
generating
revenue and a pipeline of product opportunities in development.
The Company's internal research and
development capabilities, anchored by its
proprietary MIDAS(TM) technology, are fueling product development
. This
new chemical entity is being evaluated in Phase 2 clinical trials to assess
the efficacy
and safety profiles of varying doses of this novel compound in
men experiencing erectile dysfunction
("ED") and women experiencing female
sexual dysfunction ("FSD"). The condition is correlated with
increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidemia
and smoking.
The
Company's internal research and development capabilities, anchored by its
proprietary MIDAS(TM) technology
, are fueling product development.com. King, an S+P 500 Index company, seeks to
capitalize on opportunities
in the pharmaceutical industry through the
development, including through in-licensing arrangements
and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing
and product life-cycle management.clinically endure
The main objectives of these studies are to
further evaluate
safety, treatment duration, patient populations and a range
of doses that will be incorporated into
Phase III pivotal trials.
"The initiation of these two double-blind, placebo-controlled Phase
IIb
clinical trials is a major milestone in the development of PT-141.
Although the current
ED market is primarily served by PDE-5 inhibitors
which target the vascular system, a substantial
unmet medical need exists for
alternative sexual dysfunction therapies that are effective, well-tolerated
and easy to use. Based on early clinical data, we
believe that PT-141 should not be contraindicated
in patients taking nitrates.erect veromax
For additional information regarding
Palatin, please visit Palatin
Technologies' website at http://www. These forward-looking statements reflect
managements' current
views of future events and operations, including, but not
limited to, statements pertaining to the
potential development and
commercialization of PT-141, and anticipated results and scheduled completion
of the Phase IIb clinical program for PT-141.
Dr. Some important factors which may cause
results
to differ materially from such forward-looking statements include dependence
on the companies
' abilities to carry out their respective business plans;
dependence on the successful development
and commercial acceptance of PT-141;
dependence on the companies' abilities to fund development of
PT-141;
dependence on whether a commercial product results from PT-141 development
activities;
dependence on the companies' abilities to establish and
successfully complete clinical trials necessary
for approval of PT-141 as a
treatment for sexual dysfunction; dependence on the companies' abilities
to
successfully collaborate in the development and commercialization of PT-141;
dependence on
the availability and cost of raw materials; dependence on the
unpredictability of the duration and
results of the U.S.clinically intim
Michael King Jolly, Executive Vice President, Research and Development
of King
, stated, "Together with our colleagues at Palatin, we are excited to
begin this important next step
in the clinical development program for PT-141. In addition, certain prescription drugs and psychogenic
issues
may contribute to ED.
About King Pharmaceuticals
King, headquartered in
Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company.
EXECUTIVE OFFICES
KING PHARMACEUTICALS, INC. For
example, PDE-5 inhibitors may not be effective in up to
30% of patients and are contraindicated in
patients taking nitrates, primarily
for the treatment of cardiovascular disease.
Forward
-looking Statements
This release contains forward-looking statements within the meaning of
Section
27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that
term is defined in the Private Securities
Litigation Reform Act of 1995.viagra intim
King Pharmaceuticals and
Palatin Technologies Initiate Phase IIb Clinical Trials Evaluating PT-141 in Patients Suffering from
Erectile Dysfunction
About PT-141
PT-141 is the first compound in a new drug class
called melanocortin
receptor agonists under development to treat sexual dysfunction.
4 CEDAR BROOK DRIVE, CRANBURY, NEW JERSEY 08512
The Company has one product on the
market
generating revenue and a pipeline of product opportunities in development.clinically organism
The continued
successful development of PT-141 is one of the highest
priorities of our research and development
team and is progressing as
planned.
Forward-looking Statements
This release contains
forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section
21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995.Palatin Technologies and King Pharmaceuticals Announce Publication
of Clinical Study Results of Co-Administration of PT-141 and Viagra(R)
J. Carl Spana, President and
Chief Executive Officer of Palatin, stated,
"The results of this preliminary evaluation are consistent
with the concept
that co-administration of these two therapies, each with a different yet
complementary
mechanism of action, may constitute a treatment alternative for
ED patients for whom higher doses
of a single therapy are not effective or are
not well-tolerated.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical
company.veromax erect
BRISTOL, Tenn."
The non-diabetic Phase IIb clinical trial is scheduled to conclude
in
mid-2006, while the conclusion of the diabetic Phase IIb clinical is scheduled
to follow in
the second half of 2006. It is estimated that some degree of ED affects one half
of all men over
the age of 40 and that 150 million men worldwide suffer from
ED. The mechanism of action of PT-141
may offer important
benefits over currently available products for the treatment of ED because it
acts on the pathway that controls sexual function without acting directly on
the vascular system
. Clinical data indicates that PT-141 may be effective in
treating a broad range of patients suffering
from ED.inconvenience impotence
Additionally, the clinical trials will evaluate a range of PT-141
intranasal doses between
5 mg and 15 mg.
About ED
ED is defined as the consistent inability to attain and maintain
an
erection sufficient for sexual intercourse.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual
intercourse. These forward-looking statements reflect
managements' current views of future events
and operations, including, but not
limited to, statements pertaining to the potential development
and
commercialization of PT-141. Food and Drug
Administration's ("FDA") review of Investigational
New Drug Applications
("IND"), New Drug Applications ("NDA"), and supplemental New Drug
Applications
, ("sNDA") and/or the review of other regulatory agencies
worldwide; dependence on compliance with
FDA and other government regulations
that relate to King's and Palatin's respective businesses; dependence
on
King's and Palatin's abilities to successfully manufacture PT-141; and
dependence on changes
in general economic and business conditions; changes in
current pricing levels; changes in federal
and state laws and regulations;
changes in competition; unexpected changes in technologies and technological
advances; and manufacturing capacity constraints.inconvenience destroying
The
second clinical trial will similarly evaluate
265 diabetic patients with ED. We believe
the data from this extensive Phase IIb program will allow
us to confidently
select doses, end points and treatment periods for use in the design of the
pivotal
Phase III trials," commented Dr. For example,
unlike PDE-5 inhibitors which are contraindicated
in patients taking nitrates,
primarily for the treatment of cardiovascular disease, current animal
data
indicates that PT-141 may not be contraindicated in patients taking nitrates. King, an S+P
500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription
pharmaceutical products in attractive markets and
the strategic acquisition of branded products that
can benefit from focused
promotion and marketing and product life-cycle management. The companies
do not undertake to publicly update or
revise any of their forward-looking statements even if experience
or future
changes show that the indicated results or events will not be realized. Co-
administration
therapy resulted in a significantly enhanced duration and
quality of erectile activity, compared
to Viagra monotherapy, as measured by
both RigiScan(R) and by patient self-assessment scores, respectively
. In this
group of nineteen patients, co-administration did not result in new side
effects or
in an increase in frequency or severity of side effects compared to
monotherapy.impotence premature
, King
Pharmaceuticals
(NYSE: KGPTN)
announced today that they have initiated patient enrollment in two double-
blind
, placebo-controlled Phase IIb clinical trials of PT-141 in patients with
erectile dysfunction (ED
). Many patients are
contraindicated for, or non-responsive to, PDE-5 inhibitors.S.erections premature
is a biopharmaceutical
company developing
melanocortin-based therapeutics.S.erectile fraction
PT-141 is a
melanocortin agonist that King
and Palatin are jointly developing for the
treatment of male and female sexual dysfunction.viagra clinically
The first Phase IIb clinical trial will evaluate the safety and efficacy
of PT-141 in 560 non-diabetic
patients suffering from mild to severe ED. Other important factors that may cause actual results to
differ
materially from the forward-looking statements are discussed in the "Risk
Factors" section
and other sections of King's Form 10-K for the year ended
December 31, 2004 and Form 10-Q for the
first quarter ended March 31, 2005,
and Palatin's Form 10-K for the year ended June 30, 2004 and
Form 10-Q for the
third quarter ended March 31, 2005, which are on file with the U. Preliminary
results
of this clinical trial were previously released by Palatin Technologies on
June 8, 2004
. Palatin's
strategy is to develop products and then form marketing collaborations with
industry
leaders in order to maximize their commercial potential. Other important factors
that may cause
actual results to differ materially from the forward-looking
statements are discussed in the "Risk
Factors" section and other sections of
King's Form 10-K for the year ended December 31, 2004 and
Form 10-Q for the
second quarter ended September 30, 2004, and Palatin's Form 10-K for the year
ended
June 30, 2004 and Form 10-Q for the second quarter ended December 31,
2004, which are on file with
the U.vaage erectile
and CRANBURY, N.
Dr.
501 FIFTH STREET, BRISTOL, TENNESSEE 37620
PALATIN TECHNOLOGIES, INC."
About PT-141
PT-141 is
the first compound in a new drug class called melanocortin
receptor agonists and is under development
to treat sexual dysfunction. About 150 million men worldwide and 30 million American men
suffer
from ED.palatin.ejaculation vaage
palatin.
The purpose of this initial nineteen-patient, co-administration study
was
to evaluate the potential additive effect of co-administration of Viagra(R)
(sildenafil) and
PT-141 to men with erectile dysfunction (ED).
Current literature indicates that about 40% of all
patients who receive an
initial prescription for a PDE-5 inhibitor do not renew the prescription
due
chiefly to adverse side effects, drug interaction issues, and/or the lack of
an acceptable
level of response. It is estimated that 50% of all men over the age of 40
suffer from ED. For additional
information regarding
Palatin, please visit Palatin Technologies' website at http://www.revive erections
This new
chemical entity is being evaluated in Phase IIb clinical trials studying the
efficacy and safety
profile of varying doses of this novel compound in men
experiencing erectile dysfunction ("ED") and
women experiencing female sexual
dysfunction ("FSD"). Securities and Exchange Commission.medically clinically
Current
literature indicates that about one half of all patients who receive
an initial prescription for
a PDE-5 inhibitor do not renew the prescription
due chiefly to adverse side effects, drug interaction
issues, and/or the lack
of an acceptable level of responsiveness.
About Palatin
Palatin Technologies, Inc.organism impotent
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