Palatin Technologies, Inc. and King Pharmaceuticals, Inc. Report Posit

CRANBURY, N.J. and BRISTOL, Tenn., Feb. 8 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. and King Pharmaceuticals, Inc. announced today positive results of a Phase 2A pilot clinical study evaluating PT-141 in pre-menopausal women diagnosed with female sexual dysfunction (FSD). Patients in the study receiving PT-141 reported increases in their levels of sexual desire and genital arousal compared to placebo. Additionally, there was a correlation between sexual desire and genital arousal in patients receiving PT-141, an observation that further reinforces the potential importance of these reports.

"We designed this pilot study to take a preliminary look at the effects of PT-141 as a treatment for FSD; that the results showed improvements in both genital arousal and sexual desire in such a small study population are encouraging and warrant the continued investigation of PT-141 in women with FSD," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. "As we collaborate with King Pharmaceuticals to further develop PT-141, we are confident in our collective abilities to efficiently design and complete future clinical trials that more thoroughly explore the potential benefits of PT-141 as a treatment for FSD."

Eighteen women with a diagnosis of FSD were enrolled in this double-blind, randomized, placebo controlled, single dose, cross-over clinical study. All patients enrolled in this clinical study were evaluated by Dr. Michael Perelman, Co-director, Human Sexuality Program, New York Hospital, Cornell University Medical Center and were confirmed by Dr. Perelman to have a diagnosis of FSD. Patients were administered 2 X 10 mg of intra-nasal PT-141 or placebo spray in a randomized manner and were monitored and evaluated for three hours post-dose before being discharged from the clinic. All patients completed a Treatment Satisfaction Index at 24-hours post-dose as a means of measuring their levels of sexual desire, genital arousal and, if applicable, satisfaction with sexual intercourse. Adverse events reported include nausea, headache and nasal congestion.

Palatin Technologies and King Pharmaceuticals plan to more fully present information regarding the potential market for and clinical benefits of PT-141, including the treatment of FSD, at a future conference.

About Female Sexual Dysfunction (FSD)

FSD consists of four components, hypoactive sexual desire disorder, female sexual arousal disorder, dyspareunia or painful intercourse and anorgasmia. To establish a diagnosis of FSD, these components must be associated with personal distress, as determined by the affected woman. A February 10, 1999 study published in the Journal of the American Medical Association, JAMA, titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that some form of FSD appears to be prevalent in approximately 43 percent of the female population.

About PT-141

PT-141 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 PT-141 may offer important benefits over currently available products for the treatment of ED because it appears to act on the pathway that controls sexual function without acting directly on the vascular system. Clinical data indicates that PT-141 may be effective in treating a broad range of patients suffering from ED. We anticipate that the nasal formulation of PT-141 currently under development will be as convenient as oral treatments and more patient-friendly than invasive treatments for ED, such as injections and trans-urethral pellets. It also appears to result in a rapid onset of action.

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. For example, PDE-5 inhibitors are contraindicated in patients taking nitrates, primarily for the treatment of cardiovascular disease. Based on early clinical data, we believe that PT-141 should not be contraindicated in patients taking nitrates. Current literature indicates that about 40% 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.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing melanocortin (MC)-based therapeutics. NeutroSpec(TM), the Company's proprietary radiolabeled monoclonal antibody product for imaging and diagnosing infections, has been approved by the FDA as an imaging agent for the diagnosis of equivocal appendicitis. NeutroSpec is marketed and distributed by Palatin's strategic collaboration partner, Mallinckrodt Imaging, a business unit of Tyco Healthcare. The Company is currently conducting clinical trials with its lead drug candidate, PT-141, an MC receptor agonist, for the treatment of male and female sexual dysfunction. In August 2004, Palatin entered into a strategic collaboration agreement with King Pharmaceuticals, Inc. to jointly develop and commercialize PT-141. Palatin's patented drug discovery platform, MIDAS(TM), streamlines the drug design process with an efficient approach to identifying lead compounds from proteins. For further information, visit the Palatin web site at http://www.palatin.com/.

About King Pharmaceuticals

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.

Forward-looking Statements

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 potential development and commercialization of PT-141. Some important factors which may cause results to differ materially from such forward-looking statements include dependence on the companies' abilities to carry out their respective business plans; dependence on the successful development and commercial acceptance of PT-141; dependence on the companies' abilities to fund development of PT-141; dependence on whether a commercial product results from PT-141 development activities; dependence on the companies' abilities to establish and successfully complete clinical trials necessary for approval of PT-141 as a treatment for sexual dysfunction; dependence on the companies' abilities to successfully collaborate in the development and commercialization of PT-141; 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, ("sNDA") 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 PT-141; 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, 2003 and Form 10-Q for the second quarter ended June 30, 2004, and Palatin's Form 10-K for the year ended June 30, 2004 and Form 10-Q for the first quarter ended September 30, 2004, 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.