King Pharmaceuticals And Palatin Technologies Announce End-of-Phase 2 Meeting With FDA For Bremelanotide

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Jun 2007 - 0:00 PDT

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Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has scheduled an End-of-Phase 2 meeting to discuss clinical study results with bremelanotide for the treatment of erectile dysfunction (ED). Palatin Technologies submitted a meeting request to FDA in May 2007; FDA has scheduled the meeting for August 2007.

"We look forward to discussing our Phase 2 results and plans for Phase 3 at the upcoming meeting with FDA and moving to Phase 3 trials as soon as possible," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. The purpose of the End-of-Phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies, and to identify any additional information necessary to support a marketing application.

Palatin previously announced positive results of the Phase 2b clinical trials evaluating ED in 726 non-diabetic and 294 diabetic patients at the American Urological Association Annual Meeting and at the 9th European Society for Sexual Medicine Congress. The Phase 2b clinical trials were double blind, placebo-controlled, parallel doses trials that included a 1 month run-in period and a 3 month treatment period. The results showed that up to 50% of ED patients were restored to a normal level of function.

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 focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. Palatin's lead product candidate, bremelanotide, is currently in Phase 2 clinical trials for both male and female sexual dysfunction. Palatin'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, Palatin has entered into collaborations with AstraZeneca, King Pharmaceuticals, and Tyco Healthcare Mallinckrodt. 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 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, 2006 and Form 10-Q for the quarter ended March 31, 2007 and Palatin's Form 10-K for the year ended June 30, 2006 and Form 10-Q for the quarters ended September 30, 2006, December 31, 2006 and March 31, 2007, 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.
http://www.palatin.com