Palatin Technologies and King Pharmaceuticals Report Data Showing Improvements in Sexual Relationship and Self-Esteem in Patients with Erectile Dysfunction Treated with Bremelanotide
CRANBURY, N.J., and BRISTOL, Tenn., May 22, 2007 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. and King Pharmaceuticals, Inc. reported today that data from Study 16 and Study 17 of the Phase 2B clinical trial program evaluating bremelanotide in men with erectile dysfunction (ED) were presented yesterday at the American Urological Association (AUA) Annual Meeting (AUA 2007) held in Anaheim, CA. New positive data presented showed that bremelanotide improved both self-esteem and sexual relationship in men with erectile dysfunction (ED). Other positive top line data from the Phase 2B clinical trial program were reported by the companies in November 2006 and at the 9th European Society for Sexual Medicine (ESSM) Congress in Vienna in December 2006.
In order to better understand the effects that bremelanotide may have on improving quality of life and self-esteem, patients in Study 16 were administered the SEAR (Self-Esteem and Relationship), a validated psychological instrument with two major domains: sexual relationship and confidence. The SEAR data were presented at AUA 2007 by Stanley E. Althof, PhD, Professor of Psychology, Case Western Reserve School of Medicine in a session entitled Improvement in Sexual Relationship, Satisfaction, Confidence and Self-Esteem in Erectile Dysfunction Patients Treated with Bremelanotide.
Dr. Althof commented, "Our analysis has shown that treatment with bremelanotide improved both the Self-Esteem and Sexual Relationship domains of the SEAR in non-diabetic ED patients and this was strongly correlated with improvements in erectile function. These results indicate that bremelanotide improves sexual confidence and has the potential to be an important treatment option for patients with ED."
"An increasing focus and attention on the utility of therapy in restoring quality of life and improvements to interpersonal relationships continues to evolve and will drive the need for novel treatment options for ED," Dr. Althof added.
Dr. Althof's presentation highlighted the changes from baseline in the major and minor SEAR domains at each treatment dose and also compared the analysis of the SEAR data to the improvement in erectile function as measured with the International Index of Erectile Dysfunction (IIEF). The IIEF is a clinically validated instrument with multiple domains that measure erectile function. Dr. Althof reported statistically significant correlation of changes between the IIEF and SEAR.
In Study 16, patients were randomized to receive either placebo or one of 5 doses of bremelanotide (5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg). Patients remained on treatment for 12 weeks.
SEAR Data Summary (Study 16)
In the intent-to-treat population (ITT) at 12 weeks, the mean changes in SEAR scores for both major domains are summarized in the table below (a change of 10 from baseline is considered clinically significant):
Placebo Bremelan- Bremelan- Bremelan- Bremelan- Bremelan- otide otide otide otide otide 5mg 7.5mg 10mg 12.5mg 15mg Sexual Relationship (Change from 5.0 11.1 17.1 16.1 17.2 15.0 Baseline) Confidence (Change from 5.6 5.1 10.0 9.6 12.6 11.8 Baseline)
The SEAR instrument confirmed statistically and clinically significant improvements in patient self-esteem and relationships resulting from treatment with bremelanotide. A similar dose response pattern was seen with the two minor domains, self-esteem and overall relationship.
Jed Kaminetsky, MD, Clinical Assistant Professor, Department of Urology, NYU School of Medicine conducted a podium presentation of data from Study 16, a dose ranging Phase 2B study that evaluated the safety and efficacy of bremelanotide in 726 non-diabetic patients with mild to severe ED. New data presented explored the relationship between plasma exposures in patients on bremelanotide treatment related to both efficacy and adverse events.
Christopher Steidle, MD, Clinical Associate Professor of Urology, Indiana University School of Medicine presented a poster of the data from Study 17, a dose ranging Phase 2B study that evaluated the safety and efficacy of bremelanotide in 294 patients with ED and diabetes mellitus.
"We are extremely pleased with the positive reception that our Phase 2B studies received at the AUA meeting," stated Dr. Trevor Hallam, Palatin's Executive Vice President of R&D. Dr. Hallam further commented, "We are looking forward to discussing these results with the FDA at an end of Phase 2 meeting later this year and moving to Phase 3 trials as soon as possible."
Adverse events in Study 16 and 17 across all doses, where the incidence was higher than the incidence associated with placebo, primarily included nausea, emesis, flushing, blood pressure increase, headache, and spontaneous erection, skin darkening and nasal symptoms. Except for flushing and nasal symptoms, the incidence of adverse events was dose related. The primary adverse events leading to patient discontinuation from the study were nausea, emesis and blood pressure increase. Emesis and blood pressure increase were protocol-mandated reasons for patient discontinuation. There was one incident of prolonged erection in Study 16 that was classified as a Serious Adverse Event that was likely related to bremelanotide. There were two Serious Adverse Events in Study 17 that were considered likely related to bremelanotide; an esophageal tear, secondary to emesis, and an incident of prolonged erection.
Bremelanotide is the first in a new class of drugs called melanocortin receptor agonists. It is being developed jointly by Palatin Technologies and King Pharmaceuticals for the treatment of men experiencing erectile dysfunction (ED) and women experiencing female sexual dysfunction (FSD).
Melanocortin receptor agonists work centrally on the area of the brain specific to the pathway that controls sexual function without acting directly on the vascular system. This unique mechanism of action may provide men with a novel alternative to currently available ED treatments.
Bremelanotide is administered in a convenient intranasal formulation. It is being evaluated in clinical trials studying the safety and efficacy profile of various doses in men experiencing ED and in women experiencing FSD.
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 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.
Posted: May 2007