Healthcare Industry News: female sexual dysfunction
News Release - December 20, 2006
Palatin Technologies and King Pharmaceuticals Complete Enrollment in Pre-Menopausal Cohort of a Phase 2 Clinical Trial Evaluating Bremelanotide in Pre- and Post-Menopausal Female Sexual Dysfunction PatientsCRANBURY, N.J. and BRISTOL, Tenn., Dec. 20 (HSMN NewsFeed) -- 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.
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 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.
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.
Source: Palatin Technologies
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