Bremelanotide Meets Co-Primary Endpoints in

For Immediate Release November 1, 2016

Bremelanotide Meets Co-Primary Endpoints in

Palatin's Phase 3 Trials for Hypoactive Sexual Desire

Both Phase 3 Reconnect Studies of bremelanotide for hypoactive

sexual desire disorder (HSDD) in premenopausal women met the

pre-specified co-primary efficacy endpoints of improvement in

desire and decrease in distress associated with low sexual desire

as measured using validated patient-reported outcome

The Female Sexual Function Index: Desire Domain (FSFI-D) showed a

statistically significant increase for bremelanotide compared to

placebo in both trials

Study 301: Mean change of 0.54 vs. 0.24, median change of 0.60 vs.

0.00, p=0.0002; and,

Study 302: Mean change of 0.63 vs. 0.21, median change of 0.60 vs.

The Female Sexual Distress Scale - Desires/Arousal/Orgasm

(FSDS-DAO) Item 13 showed a statistically significant reduction in

distress related to low sexual desire for bremelanotide compared to

placebo in both trials

Study 301: Mean change of -0.74 vs. -0.35, median change of -1.0

vs. 0.0, p<0.0001; and,

Study 302: Mean change of -0.71 vs. -0.41, median change of -1.0

New Drug Application (NDA) to the FDA targeted for the second half

Conference call and audio webcast at 9:00 am ET tomorrow, November

NJ November 1, 2016 Palatin Technologies, Inc.

(NYSE MKT: PTN), a biopharmaceutical company developing targeted,

receptor-specific peptide therapeutics for the treatment of

diseases with significant unmet medical need and commercial

potential, today announced positive, statistically significant

top-line results from the Reconnect Studies, its Phase 3 clinical

trial program of lead drug candidate bremelanotide. The Reconnect

Studies, investigating bremelanotide as an on-demand treatment for

premenopausal women diagnosed with hypoactive sexual desire

disorder ( HSDD ), met the pre-specified co-primary

efficacy endpoints in both Phase 3 clinical trials.

could not be more pleased with the bremelanotide Phase 3 co-primary

endpoint results. Women with HSDD using bremelanotide had

clinically meaningful and statistically significant improvements in

their desire and associated distress which are the defining

clinical issues for an HSDD diagnosis, said Carl Spana,

Ph.D., President and Chief Executive Officer of Palatin. I

am especially grateful to all of the women who volunteered to be a

part of these studies. I would also like to thank Palatin's

employees and the many consultants and third-parties that

contributed to the advancement of

D. Lucas, M.D., Chief Medical Officer of Palatin, said, In

Phase 3 trials bremelanotide was used as needed by premenopausal

women with HSDD, with a single dose self-administered in

anticipation of sexual activity. The Phase 3 studies demonstrated

that bremelanotide provided a meaningful benefit for those patients

who responded to the drug candidate. We look forward to the

opportunity to provide a new and differentiated treatment option to

the many women suffering from HSDD.

sexual desire disorder is the most prevalent form of female sexual

dysfunction, said Sheryl A. Kingsberg, Ph.D., Professor of

Reproductive Biology at Case Western Reserve University School of

Medicine, Division Chief, OB/GYN Behavioral Medicine, at University

Hospitals Cleveland Medical Center, and a clinical investigator in

the Reconnect Studies. The distress component of HSDD

reflects the profound negative impact that this condition can have

on women's self-image, relationships and quality of life well

outside the bedroom. In the Phase 3 trials we saw significant

reduction in distress with use of

expects to present additional results from the Reconnect Studies at

future sexual medicine and women's health conferences and in

peer reviewed journal publications.

Reconnect Studies Top-line Results Overview

Reconnect Studies consist of two randomized, double-blinded,

placebo-controlled Phase 3 studies, comparing the efficacy and

safety of bremelanotide versus placebo in premenopausal women

diagnosed with HSDD. The Reconnect Studies randomized 1,267 women

with HSDD. The primary efficacy analysis population was the

modified intent-to-treat (MITT) patient population, consisting of

1,202 women with HSDD in the United States and Canada. Patients

self-administered either 1.75 mg of bremelanotide or placebo as

needed in anticipation of sexual activity. The double blind or

efficacy portion of each study consisted of a 24-week treatment

evaluation period. The open-label safety extension portion of the

Reconnect Studies is ongoing.

on discussions with the FDA, it was decided that the co-primary

endpoints for the Phase 3 clinical trials were the Female Sexual

Function Index: Desire Domain (FSFI-D) and Female Sexual Distress

Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13. Satisfying sexual

events is a secondary endpoint. The FSFI-D is a validated patient

reported outcome measurement tool of sexual desire in the context

of overall sexual function. The FSDS-DAO Item 13 is a validated

patient reported outcome measurement tool of distress related to

sexual dysfunction, measuring personal distress associated with low

significance of co-primary endpoint study results was evaluated by

an independent committee using multiple anchors of patient

assessment of benefit, consistent with discussions with the FDA and

Significance for the FSFI-D Subscale: Based on application of three

selected anchors, a median value of 0.6 was set for defining

clinical significance in baseline to endpoints changes in FSFI-D

Significance for the FSDS-DAO Item 13 Score: Based on application

of three selected anchors, a median value of 1.0 point improvement

in FSDS-DAO Item 13 scores was set for defining clinical

preliminary review of the overall safety population (1,247

patients), bremelanotide appeared to be well tolerated. The most

frequent adverse event was nausea, which was generally mild in

nature. The safety profile of bremelanotide was consistent with