Palatin Technologies expands patent portfolio in the treatment of sexual dysfunction.
Palatin Technologies, Inc. (Cranbury, NJ) said that the European Patent Office has allowed claims on a patent application entitled, "Compositions for Treatment of Sexual Dysfunction sexual dysfunction
Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. " (European Patent 01196184). The European patent application corresponds to Palatin's United States Patents 6,579,968 and 6,794,489 which cover the specific structure and formulation of its lead drug under development, PT-141, for the treatment of male and female sexual dysfunction. The new European and existing United States patents cover both the specific peptide used in PT-141 and use of the pharmaceutical composition for stimulating sexual response. PT-141 was developed by Palatin scientists and the patent is owned solely by Palatin.
Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies, commented, "This patent is important to further strengthen our expansive intellectual property position surrounding our novel sexual dysfunction therapeutic. This new patent complements our existing United States patents and enhances the commercial potential of PT-141 as a treatment for sexual dysfunction."
In August 2004, Palatin entered into a collaboration agreement with King Pharmaceuticals to jointly develop and commercialize PT-141. Pursuant to the terms of the agreement, Palatin and King will share all collaboration development and marketing costs and all collaboration net profits derived from net sales Net Sales
The amount a seller receives from the buyer after costs associated with the sale are deducted.
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of PT-141 in North America based on an agreed percentage. Palatin and King may seek a partner for PT-141 for territories outside of North America and will jointly share in collaboration development and marketing costs and all collaboration revenues generated from those territories.
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 II 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 FSD Female Sexual Dysfunction
FSD File System Driver
FSD Family Support Division
FSD Fire Services Department (Hong Kong)
FSD Full Scale Development
FSD Full Scale Deflection
FSD Federal Systems Division "). The mechanism of action of PT-141 may offer important benefits over currently available products for the treatment of ED because it acts 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. The nasal formulation of PT-141 currently under development is as convenient as oral treatments, is more patient-friendly than invasive treatments for ED, such as injections and trans-urethral pellets, and appears to result in a rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. .
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. Many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors. For example, unlike PDE-5 inhibitors which are contraindicated in patients taking nitrates, primarily for the treatment of cardiovascular disease, current clinical data indicates that PT-141 should not be contraindicated in patients taking nitrates. Current literature indicates that about one half 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.
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 hyperlipidemia /hy·per·lip·id·emia/ (-lip?i-de´me-ah) elevated concentrations of any or all of the lipids in the plasma, including hypertriglyceridemia, hypercholesterolemia, etc. and smoking. In addition, certain prescription drugs and psychogenic psychogenic /psy·cho·gen·ic/ (-jen´ik) having an emotional or psychologic origin.
adj issues may contribute to ED. It is estimated that one half of all men over the age of 40 suffer from ED. About 150 million men worldwide and 30 million American men suffer from ED.
FSD consists of four components, including hypoactive sexual desire disorder, female sexual arousal disorder Female Sexual Arousal Disorder Definition
Female sexual arousal disorder (FSAD) occurs when a woman is continually unable to attain or maintain arousal and lubrication during intercourse, is unable to reach orgasm, or has no desire for sexual , dyspareunia dyspareunia /dys·pa·reu·nia/ (-pah-roo´ne-ah) difficult or painful sexual intercourse.
Difficult or painful sexual intercourse. or painful intercourse and anorgasmia anorgasmia /an·or·gas·mia/ (an?or-gaz´me-ah) inability or failure to experience orgasm.anorgas´mic . A February 10, 1999 study published in the Journal of the American Medical Association JAMA: The Journal of the American Medical Association is an international peer-reviewed general medical journal, published 48 times per year by the American Medical Association. JAMA is the most widely circulated medical journal in the world. , JAMA JAMA
Journal of the American Medical Association , titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that some form of FSD is prevalent in approximately 43 percent of the female population.
Palatin is a biopharmaceutical company focused on discovering and developing melanocortin (MC)-based therapeutics. NeutroSpec, the company's proprietary radiolabeled monoclonal antibody product for imaging and diagnosing infections, has been approved by the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. as an imaging agent for the diagnosis of equivocal appendicitis Appendicitis Definition
Appendicitis is an inflammation of the appendix, which is the worm-shaped pouch attached to the cecum, the beginning of the large intestine. The appendix has no known function in the body, but it can become diseased. . 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 Midas (mī`dəs), in Greek mythology, king of Phrygia. Because he befriended Silenus, the oldest of the satyrs, Dionysus granted him the power to turn everything into gold by touch. , streamlines the drug design process with an efficient approach to identifying lead compounds from proteins.