Palatin Technologies and King Pharmaceuticals Announce Plan To Present Results of Bremelanotide Phase 2b Studies in Men With Erectile Dysfunction
CRANBURY, N.J. and BRISTOL, Tenn., May 09, 2007 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. and King Pharmaceuticals, Inc. today announced plans to present the results from two bremelanotide Phase 2b studies of men with erectile dysfunction (ED). The presenters are Jed Kaminetsky, MD, Clinical Assistant Professor, Department of Urology, NYU School of Medicine; Stanley E. Althof, PhD, Professor of Psychology, Case Western Reserve School of Medicine and Christopher Steidle, MD, Clinical Associate Professor of Urology, Indiana University School of Medicine.
The companies plan to present the results at the American Urological Association (AUA) Annual Meeting in Anaheim, CA, which takes place May 19-24, 2007. The Phase 2b studies were designed to evaluate the safety and efficacy of bremelanotide for the treatment of male ED using a range of intranasally administered doses in an at-home environment. A total of 726 and 294 patients were enrolled in a non-diabetic ED patient study and a diabetic ED patient study, respectively. Palatin and King announced initial positive results from the Phase 2b trial evaluating bremelanotide for the treatment of male non- diabetic ED patients in November 2006.
Dr. Kaminetsky's presentation, titled "Phase 2b Study of Bremelanotide in the Treatment of ED in Non-Diabetic Males," and Dr. Althof's presentation, titled "Improvement in Sexual Relationship Satisfaction, Confidence, and Self- Esteem in ED Patients Treated with Bremelanotide," will be presented at a podium session titled "Sexual Function/Dysfunction/Andrology: Evaluation (II)" on Monday, May 21st at 1:00 PM PDT. Dr. Steidle's poster, titled "Phase 2b Study of Bremelanotide in the Treatment of ED in Diabetic Males," will be presented at a poster session titled "Sexual Function/Dysfunction/Andrology: Surgical, Medical and Non-surgical Therapy (II)" from 3:30 PM - 5:30 PM PDT on Monday, May 21st.
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.
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, 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.
King Pharmaceuticals, Inc.
Posted: May 2007