CRANBURY, N.J., and BRISTOL, Tenn., Feb. 7 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. and King Pharmaceuticals, Inc. announced today that the companies have initiated enrollment in a double-blind, placebo-controlled Phase IIb clinical trial of PT-141 in patients with female sexual arousal disorder (FSAD). The primary objective of this pilot clinical trial is to evaluate the safety and efficacy of PT-141 in FSAD patients in the "at-home" environment.
This Phase IIb clinical trial is designed to enroll approximately sixty women with a confirmed diagnosis of FSAD. The clinical trial entails a two- month treatment period and will be conducted at approximately ten clinical trial sites throughout the United States.
Dr. Trevor Hallam, Executive Vice President, Research and Development of Palatin, stated, "Together with our colleagues at King, we are very excited to commence this important, initial exploratory trial to evaluate PT-141 in FSAD patients in the 'at-home' environment. The data we gather from this study should prove significant for purposes of determining the future course of development for PT-141 in the treatment of female sexual dysfunction." The companies expect this Phase IIb clinical trial to conclude in the second half of 2006.
About PT-141
PT-141 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 II 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 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. The nasal formulation of PT-141 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
FSD consists of four components, hypoactive sexual desire 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 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'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, 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 significance of the results from the Phase IIb clinical trial of PT-141; and statements pertaining to the expected date of completion of the clinical trial. Some important factors which may cause results to differ materially from such forward-looking statements include dependence on the actual results of the companies' PT-141 development activities; dependence on the companies' abilities to fund development of PT- 141; dependence on the companies' abilities to complete the clinical trial 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 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. 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.
Palatin Technologies, Inc.CONTACT: For Palatin Technologies: Stephen T. Wills, CPA, MST, EVP-Operations / Chief Financial Officer, +1-609-495-2200, info@palatin.com;For Palatin Institutional Investors and Media: Carney Duntsch, BurnsMcClellan, +1-212-213-0006, cduntsch@burnsmc.com; For King Pharmaceuticals:James E. Green (for all King inquiries), Executive Vice President,Corporate Affairs, +1-423-989-8125
Web site: http://www.palatin.com/
