Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc.
(NYSE: KG) announced today that the companies have completed enrollment in
the pre-menopausal cohort of a Phase 2 "at-home" clinical trial evaluating
bremelanotide in pre- and post-menopausal patients experiencing female
sexual dysfunction (FSD). The FSD clinical trial is designed to evaluate
the initial multiple-dose safety and efficacy of bremelanotide in both pre-
and post- menopausal women, and will provide the companies with information
that will guide selection of clinical endpoints and estimates of treatment
effect size for future clinical trials. The results from this trial are
anticipated to be released in calendar year 2007. Bremelanotide is a drug
candidate for the treatment of male and female sexual dysfunction and is
being developed for regulatory approval and commercialization by Palatin
and King Pharmaceuticals.
"Based on positive results from a pilot safety/clinical pharmacology
study evaluating bremelanotide in FSD patients, Palatin and King
Pharmaceuticals are jointly committed to advancing the clinical development
of bremelanotide for FSD and are pleased to report continued progress in
the execution of our development program," said Trevor Hallam, Ph.D.,
Palatin's Executive Vice President of Research & Development. "Both female
sexual dysfunction and male sexual dysfunction represent significant market
opportunities where we believe bremelanotide has the potential to address
unmet medical needs."
About Female Sexual Dysfunction (FSD)
FSD consists of four components, hypoactive sexual desire disorder,
female sexual arousal disorder, dyspareunia or painful intercourse and
anorgasmia. To establish a diagnosis of FSD, these components must be
associated with personal distress, as determined by the affected woman. A
February 10, 1999 study published in the Journal of the American Medical
Association, JAMA, titled, "Sexual Dysfunction in the United States:
Prevalence and Predictors," states that some form of FSD appears to be
prevalent in approximately 43 percent of the female population.
About Bremelanotide (formerly PT-141)
Bremelanotide is the first compound in a new drug class called
melanocortin receptor agonists under development to treat sexual
dysfunction. This new chemical entity is being evaluated in Phase 2
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). The mechanism of action
of bremelanotide 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 bremelanotide may be effective in treating a
broad range of patients suffering from ED.
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. Many patients are
contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition,
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 ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. 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.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company primarily
engaged in the development of melanocortin-based therapeutics. The Company
has a pipeline of product candidates in development. The Company's internal
research and development capabilities, anchored by its proprietary
MIDAS(TM) technology, are fueling product development. Palatin's strategy
is to develop products and then form marketing collaborations with industry
leaders in order to maximize their commercial potential. To date, the
Company has formed partnerships with Tyco Healthcare Mallinckrodt and King
Pharmaceuticals. For additional information regarding Palatin, please visit
Palatin Technologies' website at palatin.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. 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.
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. These forward-looking statements reflect
managements' current views of future events and operations, including, but
not limited to, statements pertaining to the anticipated data of release of
the clinical trial results; proposed indications for bremelanotide; the
significance of the results from the clinical trials of bremelanotide; and
the conduct of future clinical trials. Some important factors which may
cause results to differ materially from such forward-looking statements
include dependence on the actual results of the companies' bremelanotide
development activities; dependence on the companies' abilities to fund
development of bremelanotide; dependence on the companies' abilities to
complete clinical trials as anticipated; dependence on the availability and
cost of raw materials; dependence on the unpredictability of the duration
and results of the U.S. Food and Drug Administration's ("FDA") review of
Investigational New Drug Applications ("IND"), New Drug Applications
("NDA"), and supplemental New Drug Applications ("sNDAs"), 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 bremelanotide; 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. 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, 2005 and Form 10-Q for
the quarter ended September 30, 2006, and Palatin's Form 10-K for the year
ended June 30, 2006, which are on file with the U.S. Securities and
Exchange Commission. 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.
King Pharmaceuticals, Inc.
palatin
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