BRISTOL, Tenn., and CRANBURY, N.J., Feb. 8 /PRNewswire-FirstCall/ -- King
Pharmaceuticals, Inc. (NYSE: KG) and Palatin Technologies, Inc. (Amex: PTN)
announced today that the United States Adopted Names (USAN) Council and the
World Health Organization (WHO) have approved the generic name bremelanotide
for PT-141. Bremelanotide is a melanocortin agonist being developed jointly
by King and Palatin for the treatment of male and female sexual dysfunction.
The approval by the USAN Council and WHO formally recognizes melanocortin
agonists as a distinct therapeutic class and makes bremelanotide the first
melanocortin agonist to have an approved generic name.
The purpose of the USAN Council is to select simple, informative and
unique nonproprietary names for drugs based on pharmacological and/or chemical
relationships. The Council is sponsored by the American Medical Association,
the United States Pharmacopeial Convention and the American Pharmacists
Association. The Council works closely with the World Health Organization's
International Nonproprietary Name Program.
"We are pleased that USAN and WHO have recognized this distinct class of
medications, which employ the melanocortin pathway to modify biological
processes," said Steve Andrzejewski, Chief Commercial Officer of King. "We
believe bremelanotide will be an important advance in the treatment of sexual
dysfunction and, with its unique mechanism of action, represents new hope for
patients with this condition."
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 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"). 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. The nasal formulation of bremelanotide currently
under development is as convenient as oral treatments, is more patient-
friendly than invasive treatments for ED, such as injections and trans-
urethral pellets, and appears to result in a rapid onset of action.
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 correlates 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 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 Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company primarily
engaged in the development of melanocortin-based therapeutics. The Company's
internal research and development programs, anchored by its proprietary
MIDAS(TM) technology, have provided product candidates for the treatment of
sexual dysfunction, obesity, congestive heart failure, cachexia and diagnosis
of sites of infection. 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
http://www.palatin.com.
About King Pharmaceuticals
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 potential for bremelanotide as an
advance in the treatment of sexual dysfunction. 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 bremelanotide; dependence on the companies' abilities to fund
development of bremelanotide; dependence on whether a commercial product
results from bremelanotide development activities; dependence on the
companies' abilities to establish and successfully complete clinical trials
necessary for approval of bremelanotide as a treatment for sexual dysfunction;
dependence on the companies' abilities to successfully collaborate in the
development and commercialization of bremelanotide; 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, ("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 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, 2004 and Form 10-Q for the third quarter ended September 30,
2005, and Palatin's Form 10-K for the year ended June 30, 2005 and Form 10-Q
for the first quarter ended September 30, 2005, 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.
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
http://www.palatin.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, +1-423-989-8125; or
Stephen T. Wills, CPA, MST EVP-Operations - Chief Financial
Officer of Palatin Technologies, +1-609-495-2200, or
info@palatin.com; or Carney Duntsch of Burns McClellan,
+1-212-213-0006, or cduntsch@burnsmc.com, for Palatin
Institutional
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