Palatin Technologies and King Pharmaceuticals Announce Presentation Regarding Clinical Study Evaluating Bremelanotide in Post-Menopausal Female Sexual Dysfunction Patients
CRANBURY, N.J. and BRISTOL, Tenn., February 26, 2007 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. and King Pharmaceuticals, Inc. announced that data from Part 2 of a Phase IIa pilot study evaluating the effects of bremelanotide in post-menopausal women diagnosed with female sexual arousal disorder (FSAD) was presented yesterday, February 25, 2007, at the International Society for the Study of Women's Sexual Health (ISSWSH) 2007 Annual Meeting. The presentation titled "Randomized, Placebo- Controlled, Crossover Study to Evaluate the Effects of Intranasal Bremelanotide on Perceptions of Desire and Arousal in Postmenopausal Women With Sexual Arousal Disorder" was presented by Dr. Michael Perelman of the NY- Presbyterian Weill Cornell Medical Center in New York. Dr. Stephen B. Levine of School of Medicine, Cleveland, Ohio, was a co-author of the presentation.
The Companies previously reported preliminary data from this study in a press release on August 3, 2006. The results of this Phase IIa study showed that on a 14-item questionnaire, 73 percent of the women reported an increased level of genital arousal while on bremelanotide compared with 23 percent of women on placebo. Also, 46 percent of women on bremelanotide reported an increased level of sexual desire while only 19 percent of women responded similarly after placebo treatment. Additionally, subjects receiving bremelanotide reported a higher incidence of engaging in sexual activity compared to placebo. The current study follows a similarly designed clinical study conducted with pre-menopausal patients with FSAD, the results of which were recently published in the July 2006 issue of The Journal of Sexual Medicine.
Twenty-seven women with a diagnosis of FSAD were enrolled at two investigational sites in this double-blind, randomized, placebo-controlled, single dose, cross-over clinical study. All subjects enrolled in this clinical study were evaluated by an experienced clinical psychologist and were confirmed to have a diagnosis of FSAD. Subjects were administered a 20 mg dose (2 x 10 mg) of intranasal bremelanotide or placebo spray in a randomized manner and were monitored and evaluated for three hours post-dose before being discharged from the clinic. All subjects completed a Treatment Satisfaction Index questionnaire at 24-hours post-dose as a means of measuring their levels of sexual desire, genital arousal and, if applicable, satisfaction with sexual activity. Adverse events reported include nausea, headache and nasal congestion and were comparable to adverse events reported for other clinical studies evaluating this dose.
"The data strongly favor and support the companies' development program for bremelanotide," states Dr. Michael A. Perelman, Co-Director of the Human Sexuality Program at Weill Medical College of , New York. "I enthusiastically await data from larger clinical trials which are underway."
Palatin Technologies and King Pharmaceuticals are currently enrolling 150 post-menopausal FSAD patients in a Phase IIb at-home clinical trial at approximately 20 clinical sites throughout the United States. The enrollment of pre-menopausal FSAD patients for this study has completed.
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.
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 AstraZeneca, King Pharmaceuticals and Tyco Healthcare Mallinckrodt.
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.
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 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 and Form 10-Q for the quarters ended September 30, 2006 and December 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.
Posted: February 2007