PL-6983 is the lead compound in a new series of melanocortin receptor-specific peptides developed
by Palatin Technologies. PL-6983 has demonstrated efficacy in inducing erections in animal models and in inducing sexual behavior in an animal model of female sexual dysfunction (FSD).
Palatin Technologies is developing PL-6983 primarily for FSD, a major unmet medical need. Depending on results of clinical trials, Palatin Technologies may also seek to develop PL-6983 for erectile dysfunction (ED).
Palatin Technologies discontinued development of bremelanotide for sexual dysfunction fol owing concerns raised by the U.S. Food and Drug Administration (FDA) about the acceptable benefit/risk ratio as a first-line therapy for erectile dysfunction related primarily to increases in blood pressure observed in some patients. Palatin Technologies applied its expertise in the melanocortin field to develop a new series of novel and proprietary peptides specifical y designed to treat sexual dysfunction but with limited effects on systemic blood pressure.
Palatin Technologies has filed patent applications on its new series of peptides. Based on priority dates for the patent applications, patents granted on these applications wil have a patent term through 2029, and may be eligible for patent term extensions. Palatin Technologies intends to seek patent protection both in the United States and international y.
Palatin Technologies has developed a novel screening platform that examined the effectiveness of
peptides both in animal models of sexual response and sexual dysfunction and the cardiovascular effects of the peptides, primarily looking at changes in blood pressure. Based on these studies, Palatin Technologies selected PL-6983 for further development. While PL-6983 has some effect on blood pressure in animal models, the minimum effective dose required to induce an erection in male animals is approximately one-tenth the minimum effective dose required to increase blood pressure. In the same models, bremelanotide induced blood pressure increases at a lower dose than that required to induce erections.
Palatin Technologies is planning preclinical toxicology and other studies required by the FDA prior to initiating human clinical trials.
Initial human clinical trials wil be designed to measure safety parameters, including changes in blood pressure fol owing administration. It is anticipated that these initial studies wil be conducted in men, but assuming favorable efficacy results without significant increases in blood pressure, future studies wil be conducted in women with FSD.
Palatin Technologies, Inc. • 4-C Cedar Brook Drive • Cranbury, NJ 08512 • Phone (609) 495-2200 • Fax (609) 495-2201 • www.palatin.com
Female sexual dysfunction is a multifactorial condition that has anatomical, physiological, medical,
psychological and social components. There are no FDA approved pharmaceutical products for FSD. Studies estimate FSD is prevalent in approximately 50% of women over the age of 30, and that more than 35 mil ion women in the United States may be afflicted with some form of FSD. FSD includes disorders associated with desire, arousal, orgasm and pain.
More About FSDFemale sexual disorder is defined by the American Foundation for Urologic Disease as: “The persistent or recurrent inability to attain or maintain sufficient sexual excitement, causing personal distress. It may be expressed as a lack of subjective excitement or a lack of genital or other somatic responses.” FSD consists of four components, hypoactive sexual desire disorder, female sexual arousal disorder (FSAD), 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.
Erectile dysfunction is defined as the consistent inability of a male 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 50% of all men over the age of 40 and that 150 mil ion men worldwide suffer from ED.
There is tremendous competition and incentive to develop, market and sel drugs for the treatment of
FSD. A number of hormonal therapies, including progestin, androgen and localized estrogen therapies, have been commercialized; however, these are effective in a comparatively smal percentage of cases, and have not gained widespread market acceptance. Despite the fact that a number of drugs are in various stages of research or development for FSD, none utilize melanocortin pathways as their mechanism of action. Clinical trials using bremelanotide conducted by Palatin Technologies validates the potential utility of MC4-R agonists for treatment of FSD.
Although the current ED market is primarily served by PDE-5 inhibitors which target the vascular system, such as Viagra® (sildenafil), Levitra® (vardenafil) and Cialis® (tadalafil), there is a substantial unmet medical need for alternative sexual dysfunction therapies. Many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition, current literature indicates that about one half of al 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.
The statements in this Fact Sheet that relate to future plans, events or performance are forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve significant risks and uncertainties, and actual results, events and performance may differ material y from those expressed or implied in this Fact Sheet. Factors that could cause such differences include, but are not limited to, risks
pertaining to product development, clinical trial outcomes, regulatory requirements and actions, availability of required
financing and other sources of funds, corporate partnering agreements and other risks disclosed in the our most recent Annual
Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. The forward-looking
statements in this presentation do not constitute guarantees of future performance. We undertake no obligation to publicly
update these forward-looking statements to reflect events or circumstances that occur after the date of this Fact Sheet.
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