Navigation Links
King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program With Bremelanotide for Erectile Dysfunction
Date:8/30/2007

CRANBURY, N.J. and BRISTOL, Tenn., Aug. 30 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that they have delayed plans for the initiation of Phase 3 clinical trials with bremelanotide, a first in class melanocortin agonist drug candidate, for the treatment of male erectile dysfunction (ED). The decision follows responses from representatives of the U.S. Food and Drug Administration (FDA), which raised serious concerns about the acceptable benefit/risk ratio to support the progression of the proposed program into Phase 3 studies for ED.

After reviewing the data generated in the Phase 1 and 2 studies, the FDA questioned the overall efficacy results and the clinical benefit of this product in both the general and diabetic ED populations, and cited blood pressure increases as its greatest safety concern. Though not supportive of the proposed Phase 3 studies for ED with bremelanotide, the FDA stated that it was amenable to proposals for a different drug development pathway, such as for a second-line therapy in non-responders to currently approved PDE-5 inhibitors.

"The safety of patients in our clinical program has always been our number one priority and we will work closely with the FDA, King, and our advisors to determine the next steps for the program," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin.

Palatin and King plan to review the FDA comments in the overall context of the program in order to determine next steps related to the further development of bremelanotide for the treatment of ED.

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 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.


'/>"/>
SOURCE Palatin Technologies, Inc.; King Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
6. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
7. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
8. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Global Blood Therapeutics, ... company developing novel therapeutics for the treatment of ... announced the closing of its previously announced underwritten ... at the public offering price of $18.75 per ... were offered by GBT. GBT estimates net proceeds ...
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... today announced the appointment of Dr. Edward ... as a Non-Executive Director, effective June 23, 2016.Dr. ... Compensation and Nominations and Governance Committees.  As a ... will provide independent expertise and strategic counsel to ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
Breaking Medicine News(10 mins):