CRANBURY, N.J. and BRISTOL, Tenn., June 22 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced today the publication of a manuscript entitled "An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT-141), a Melanocortin Receptor Agonist" in the Journal of Sexual Medicine July 2006 - Vol. 3, Issue 4.
The purpose of Part 1 of this 2-Part Phase IIa pilot study was to evaluate the effect of bremelanotide, a first-in-class melanocortin agonist, in 18 premenopausal women, ages 22 to 44 years old, diagnosed with female sexual arousal disorder (FSAD). These patients received an intranasal 20 mg dose (2 x 10 mg) of bremelanotide or placebo during the first in-clinic session and the alternate medication in the second in-clinic session. The patient's vaginal pulse amplitude (VPA) was monitored 20 minutes before dosing until 60 minutes following dosing. After a 24-hour at-home period, the patients completed a questionnaire assessing their sexual activity and their subjective evaluation of sexual desire and sexual arousal.
Although there were no changes in VPA during the immediate post-dose period when comparing bremelanotide to placebo, the data indicated a positive correlation between sexual desire and genital arousal in patients receiving bremelanotide treatment in the 24-hour at-home period. Exploratory results showed that on a 14-item questionnaire, 67 percent of women on bremelanotide reported an increased level of sexual desire while only 22 percent of women responded similarly after placebo treatment. Seventy-two percent of the women reported an increased level of genital arousal while on bremelanotide compared with 39 percent of women on placebo. Common adverse events reported included nausea and headache.
"Clinical and pre-clinical data, taken collectively, evoke a cautious optimism leading me to strongly encourage the sponsor to continue evaluation of bremelanotide for the treatment of female sexual dysfunction," states Dr. Michael A. Perelman, Co-Director of the Human Sexuality Program at Weill Medical College of Cornell University, New York. "The potential use of this centrally acting compound to treat FSAD is the most interesting development in sexual medicine research in years. Once concluded, I look forward to reviewing data from the ongoing clinical trials."
Palatin and King plan to jointly announce the results of the second part of the Phase IIa pilot study in 25 post-menopausal FSAD patients in the second-half of 2006. Additionally, the companies have initiated a 100 patient, Phase IIb at-home clinical trial in premenopausal FSAD patients. Patients are currently being enrolled in this Phase IIb study at approximately twenty clinical sites throughout the United States.
About Bremelanotide
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 FSD
Female sexual disorder is defined by the American Foundation for Urologic Disease as: "The persistent or recurrent inability to attain or maintain sufficient sexual excitement, causing personal distress. It may be expressed as a lack of subjective excitement or a lack of genital or other somatic responses." FSD consists of four components, hypoactive sexual desire disorder, female sexual arousal disorder (FSAD), 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, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company developing 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 http://www.palatin.com.
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 proposed indications for bremelanotide; the significance of the results from the clinical trials of bremelanotide; and the expected date of completion of 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 March 31, 2006, and Palatin's Form 10-K for the year ended June 30, 2005 and Form 10-Q for the quarters ended September 30, 2005, December 31, 2005 and March 31, 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.
SOURCE Palatin Technologies, Inc.; King Pharmaceuticals, Inc.