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DATED AUGUST 30, 2007 N E W S R E L E A S E

Key Takeaway: FOR RELEASE August 30, 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 Pharmaceuti

Full Press Release Details

FOR RELEASE August 30,
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.
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.
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.
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
PALATIN TECHNOLOGIES,
4C CEDAR BROOK DRIVE, CRANBURY, NEW JERSEY 08512
KING PHARMACEUTICALS,
501 FIFTH STREET, BRISTOL, TENNESSEE 37620
Last updated: Aug 30, 2007