-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IEgY2oKwCMig1w2j/N8hO+p8p+K8OtzzPxq9SGwwZJDMmX0d6kvzL5rNLHELtwdr zczo3EAIiwD47cfi/sYb+w== 0001088020-07-000039.txt : 20070830 0001088020-07-000039.hdr.sgml : 20070830 20070830111034 ACCESSION NUMBER: 0001088020-07-000039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070830 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070830 DATE AS OF CHANGE: 20070830 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PALATIN TECHNOLOGIES INC CENTRAL INDEX KEY: 0000911216 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 954078884 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15543 FILM NUMBER: 071089889 BUSINESS ADDRESS: STREET 1: 4C CEDAR BROOK DRIVE CITY: CRANBURY STATE: NJ ZIP: 08512 BUSINESS PHONE: 609-495-2200 MAIL ADDRESS: STREET 1: 4C CEDAR BROOK DRIVE CITY: CRANBURY STATE: NJ ZIP: 08512 FORMER COMPANY: FORMER CONFORMED NAME: INTERFILM INC DATE OF NAME CHANGE: 19930825 8-K 1 form8k_083007.htm Palatin Technologies, Inc. Form 8-K August 30, 2007

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549




FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act Of 1934

Date of Report (Date of earliest event reported):   August 30, 2007


Palatin Technologies, Inc.
(Exact name of registrant as specified in its charter)


Delaware 001-15543 95-4078884
(State or other jurisdiction (Commission (IRS employer
of incorporation) File Number) identification number)

4C Cedar Brook Drive, Cranbury, NJ 08512
(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code:  (609) 495-2200


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 8.01  Other Events

        On August 30, 2007, we issued a press release concerning our delay of plans for the initiation of Phase 3 clinical trials with bremelanotide for the treatment of male erectile dysfunction. We have included that press release as Exhibit 99 to this report.

        Neither the filing of the press release as an exhibit to this report nor the inclusion in the press release of a reference to our internet address shall, under any circumstances, be deemed to incorporate the information available at our internet address into this report. The information available at our internet address is not part of this report or any other report filed by us with the Securities and Exchange Commission.

Item 9.01  Financial Statements and Exhibits.

(c)   Exhibits:

  99     Press Release dated August 30, 2007



Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


    PALATIN TECHNOLOGIES, INC.
     
     
Date: August 30, 2007   By:  /s/ Stephen T. Wills              
      Stephen T. Wills, CPA, MST
      Executive Vice President - Operations and
      Chief Financial Officer



-2-




EXHIBIT INDEX


  99 Press Release dated August 30, 2007

EX-99 2 ex99.htm PRESS RELEASE DATED AUGUST 30, 2007

N E W S R E L E A S E


LOGO LOGO

FOR RELEASE August 30, 2007 at 8:00 AM EDT

KING PHARMACEUTICALS AND PALATIN TECHNOLOGIES
DELAY IMMEDIATE PLANS FOR PHASE 3 CLINICAL PROGRAM WITH
BREMELANOTIDE FOR ERECTILE DYSFUNCTION

CRANBURY, N.J. and BRISTOL, Tenn., August 30, 2007 — 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


-More-


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™ 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.


Contacts:
For Palatin Technologies:
Stephen T. Wills, CPA, MST
EVP-Operations / Chief Financial Officer
(609) 495-2200
info@palatin.com
 
For Palatin Institutional Investors and Media:
Carney Noensie
Burns McClellan
(212) 213-0006
cnoensie@burnsmc.com
   
For King Pharmaceuticals:
James E. Green (for all King inquiries)
Executive Vice President
Corporate Affairs
423-989-8125
 


EXECUTIVE OFFICES

PALATIN TECHNOLOGIES, INC.
4C CEDAR BROOK DRIVE, CRANBURY, NEW JERSEY 08512

KING PHARMACEUTICALS, INC.
501 FIFTH STREET, BRISTOL, TENNESSEE 37620



###

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