Palatin Technologies, Inc. Reports Positive Data From An At Home Study Of Pre And Postmenopausal Women With Female Sexual Arousal Disorder

Palatin Technologies, Inc.
(Amex: PTN) announced positive results from an at home Phase 2 trial
evaluating bremelanotide for the treatment of female sexual arousal
disorder (FSAD). The objective of this exploratory study was to identify
potential efficacy endpoints for future studies and to evaluate the safety
of intranasal (IN) bremelanotide, relative to placebo and under the
conditions of home use, for the treatment of FSAD in pre and
postmenopausal women.



"We are pleased with the overall data from this exploratory trial. The
efficacy response was consistent and robust across all domains,
particularly desire and arousal. We look forward to discussing the
program's further development with the FDA, including future dose-ranging
studies to improve the drug's benefit/risk profile," stated Dr. Trevor
Hallam, Executive Vice President of Research & Development for Palatin.



Study Highlights



The trial was double-blinded, placebo-controlled and enrolled 76
premenopausal and 87 postmenopausal women who were followed for one month
to determine their baseline level of sexual dysfunction. The patients were
then randomized to receive IN doses of either placebo or 10 mg of
bremelanotide. Changes in their level of sexual function were assessed over
a two month period using the Female Sexual Encounter Profile (FSEP), the
Female Sexual Function Index (FSFI) and the Female Sexual Distress Score
(FSDS). The first dose was given in the clinic. Prespecified changes in
blood pressure, as well as emesis, led to mandatory discontinuation. All
endpoints were exploratory without preset statistical goals.



Postmenopausal Patient Efficacy Results



In the Intention to Treat Population, the bremelanotide treated
postmenopausal women showed statistically significant improvements,
compared to baseline and placebo, in desire and arousal success rates, and
overall satisfaction at one and two months. In these patients, the FSFI
domains of arousal, desire and orgasm were statistically significantly
improved compared to placebo at one month. The arousal and orgasm domains
were statistically significantly improved compared to placebo at one and
two months.



Premenopausal Patient Efficacy Results



In the Intention-to-Treat Population, the bremelanotide treated
premenopausal women showed statistically significant improvements, compared
to baseline, in desire and arousal success rates, and overall satisfaction
at one and two months. However, while there was a consistent trend to
greater improvement in these measures in bremelanotide patients compared to
placebo treated patients, the differences were not statistically
significant between bremelanotide and placebo treated patients because the
placebo responses were themselves statistically significantly improved
compared to baseline.



Pre and Postmenopausal Safety Results
















Adverse events where the incidence was higher than the incidence
associated with placebo primarily included nausea, emesis, flushing, blood
pressure increase, headache and nasal symptoms. There were no serious
adverse events related to bremelanotide. The most common cause for
mandatory discontinuation was protocol-specified blood pressure increase
criteria.



Preliminary Conclusions



Based on these data, Palatin is encouraged about the use of
bremelanotide for FSAD and believes that future studies in patients with
FSAD are warranted. Future dose-ranging studies at 10 mg and lower will be
necessary to improve the drug's benefit/risk ratio. Palatin plans to engage
the FDA in discussions regarding future development later this calendar
year.



Dr. Eileen Palace, The Center for Sexual Health, Metairie, LA, stated,
"With no approved medical therapies to treat patients with FSAD, I believe
the results of the clinical trials with bremelanotide warrant further
development." Dr. Palace is an investigator who enrolled patients in the
study and a member of the Bremelanotide Scientific Advisory Board.




Palatin's executive management will present additional detail of the
results of this study at future scientific meetings.



About Female Sexual Dysfunction (FSD)



FSD includes four disorders, hypoactive sexual desire disorder, female
sexual arousal disorder, dyspareunia and anorgasmia. To establish a
diagnosis of FSD, these syndromes 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, titled,
"Sexual Dysfunction in the United States: Prevalence and Predictors,"
states that approximately 43 percent of the postmenopausal female
population suffers from some form of FSD.



About Palatin Technologies, Inc.



Palatin Technologies, Inc. is a biopharmaceutical company focused on
discovering and developing targeted, receptor-specific small molecule and
peptide therapeutics. 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. The Company currently has collaborations with
AstraZeneca and the Mallinckrodt division of Covidien. For additional
information regarding Palatin, please visit the Company's website at
palatin.



Forward-looking Statements



Statements about the Company's future expectations, including
statements about its development programs, the significance of the results
of clinical trials, the conduct of future clinical trials, proposed
indications for its product candidates, pre-clinical activities, marketing
collaborations, and all other statements in this document other than
historical facts, are "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. The Company intends that such
forward-looking statements shall be subject to the safe harbors created
thereby. Palatin's actual results may differ materially from those
discussed in the forward-looking statements for various reasons, including,
but not limited to the Company's ability to fund development of its
technology, ability to establish and successfully complete clinical trials
and pre-clinical studies and the results of those trials and studies,
dependence on its partners for certain development activities, need for
regulatory approvals and commercial acceptance of its products, ability to
recommence marketing and gain commercial acceptance of NeutroSpec(R),
ability to protect its intellectual property, and other factors discussed
in the Company's annual report and Form 10-K for the year ended June 30,
3007 and other periodic filings with the Securities and Exchange
Commission. The Company is not responsible for updating for events that
occur after the date of this press release.


Palatin Technologies, Inc.

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