Healthcare Industry News: Mallinckrodt
News Release - November 6, 2006
Palatin Technologies and King Pharmaceuticals Report Results For Two Phase 2B Clinical Trials Evaluating Bremelanotide in Male Erectile Dysfunction PatientsTrials Demonstrate Potential Effectiveness of Bremelanotide in Both Diabetic and Non-diabetic ED Patients
CRANBURY, N.J. and BRISTOL, Tenn., Nov. 6 (HSMN NewsFeed) -- Palatin Technologies, Inc. (Amex: PTN ) and King Pharmaceuticals, Inc. (NYSE: KG ) announced today positive results from two Phase 2B trials evaluating bremelanotide for the treatment of male erectile dysfunction (ED). The two Phase 2B clinical trials were double-blind, placebo-controlled, parallel dose trials that included a one month run-in period and a three-month treatment period.
Dr. King Jolly, Executive Vice President of Research & Development for King, stated, "Together with our colleagues at Palatin, we are pleased with the data from these two trials, which demonstrate the potential effectiveness of bremelanotide as a treatment option for patients with ED. Accordingly, we look forward to further assessing the data from these two trials and our other Phase 2 investigations as we move forward with our development plan."
"The trial met its objectives and I feel confident we can develop a scientifically rigorous Phase 3 clinical program incorporating doses that have both adequate efficacy and acceptable tolerability to discuss with the FDA at an upcoming end-of-Phase 2 meeting," said Dr. Trevor Hallam, Executive Vice President, Research and Development of Palatin.
The primary efficacy endpoint for both trials was the change in the Erectile Function domain of the International Index of Erectile Function (IIEF-ED) from baseline to the end of the three-month treatment period. Study 16 was a clinical trial evaluating the safety and efficacy of bremelanotide in 726 non-diabetic patients with mild to severe ED. Study 17 similarly evaluated 294 patients with ED and diabetes mellitus. The primary objective of the studies was to characterize the efficacy and safety of bremelanotide in these two ED populations and to identify the dose(s) to use in further development. Data from these and other studies will be the basis for discussions with the U.S. Food and Drug Administration (FDA) at an end-of- Phase 2 meeting.
Study 16 Highlights
726 non-diabetic ED patients were randomized to receive placebo or bremelanotide doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg. These patients were followed for 3 months. In the Per Protocol Population and the Intent to Treat Population, four of the five doses evaluated (7.5, 10, 12.5 and 15 mg) had clinically and statistically significant changes in the primary efficacy endpoint, IIEF-ED, relative to placebo.
In the Per Protocol Population, IIEF-ED changes ranged from 5.7 for the 7.5 mg dose to 8.4 for the 15 mg dose, compared to 1.8 for placebo. A change of 4 points from baseline in the IIEF-ED is considered clinically significant. Additionally, these same four doses had clinically and statistically significant changes relative to placebo, as measured by the Sexual Encounter Profile (SEP) Questions #3 and #4 (relating to penetration and ejaculation) and the Global Assessment Questionnaire (GAQ), a subjective questionnaire regarding patient satisfaction with bremelanotide, relative to placebo. SEP Questions #2 and #3 and the GAQ were secondary efficacy endpoints in both Study 16 and Study 17.
Adverse events across all doses, where the incidence was higher than the incidence associated with placebo, primarily included nausea, emesis, flushing, blood pressure increase, headache, spontaneous erection and nasal symptoms. Except for flushing and nasal symptoms, the incidence of adverse events was dose related. The primary adverse events causing 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 that was classified as a Serious Adverse Event that was likely related to bremelanotide.
Study 17 Highlights
294 diabetic ED patients were randomized to receive placebo or bremelanotide doses of 10 mg, 12.5 mg or 15 mg doses. The design of Study 17 was similar to Study 16. In the Per Protocol Population the 12.5 mg and 15 mg doses had a change of 5.9 and 7.1, respectively, in the IIEF-ED that was clinically and statistically significant relative to the placebo change of 2.3. Although none of the doses evaluated (10, 12.5 and 15 mg) were statistically significantly different from placebo for SEP Questions #2 and #3, all three doses were statistically significantly different than placebo for the GAQ.
Adverse events across all doses, where the incidence was higher than the incidence associated with placebo, primarily included nausea, emesis, flushing, blood pressure increase, headache, 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 causing patient discontinuation from the study were nausea, emesis and blood pressure increase. As with Study 16, emesis and blood pressure increase were protocol-mandated reasons for patient discontinuation. There were two Serious Adverse Events that were considered likely related to bremelanotide: an esophageal tear, secondary to emesis, and an incident of prolonged erection.
Based on these and other studies, Palatin and King, in conjunction with a Scientific Advisory Board, have determined to continue data assessments as they prepare for an end-of-Phase 2 meeting with the FDA.
Dr. Christopher Steidle, Clinical Associate Professor of Urology at the Indiana University School of Medicine stated, "There is a need for new agents to treat patients with ED. New agents must achieve both clinically meaningful and statistically significant results for the endpoints established for evaluation of ED drugs. Having achieved such results, bremelanotide has demonstrated its potential as an effective treatment for patients with ED. Additionally, given the ongoing unmet medical need of diabetic patients with ED, the efficacy results of the diabetic study (Study 17) are especially encouraging." Dr. Steidle is an investigator who enrolled patients in both Studies 16 and 17 and a member of the Bremelanotide Scientific Advisory Board.
Palatin's executive management will present additional detail of the results of these two Phase 2 studies at the Rodman & Renshaw 8th Annual Healthcare Conference on Monday, November 6, 2006 at 4:35 PM EST at the New York Palace Hotel, New York, NY, and at the CIBC World Markets 17th Annual Healthcare Conference on Wednesday, November 8, 2006 at 1:15 PM EST at the Waldorf-Astoria, New York, NY. The presentations will be webcast live and can be accessed by logging on to the Investors section of Palatin Technologies' website at http://www.palatin.com on the day of the event. A replay of the presentation will also be available on Palatin's website.
In addition, presentations of these results are planned at future scientific meetings, including a podium presentation at the 9th European Society for Sexual Medicine (ESSM) Congress to be held at the Hofburg Convention Center, Vienna on December 5, 2006.
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 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 June 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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