Palatin Technologies, Inc., a biopharmaceutical company, develops receptor-specific peptide therapeutics for the treatment of diseases. The company’s programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. In addition, the company has drug candidates or development programs for obesity, erectile dysfunction, cardiovascular diseases, pulmonary diseases, inflammatory diseases and dermatologic diseases. Drug Development Programs The company’s primary product in clinical development is bremelanotide for the treatment of female sexual dysfunction (FSD). Bremelanotide is an on-demand subcutaneous injectable peptide melanocortin receptor agonist for treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual response. Bremelanotide is in Phase 3 clinical trials. Melanocortin receptor-4 (MC4r) compounds for treatment of obesity and diabetes. PL-3994 is a natriuretic peptide receptor-A (NPR-A) agonist, for treatment of cardiovascular and pulmonary indications. PL-3994 is its lead natriuretic peptide receptor product candidate, and is a synthetic mimetic of the neuropeptide hormone atrial natriuretic peptide (ANP). PL-3994 is in development for treatment of heart failure, acute exacerbations of asthma and refractory hypertension. Melanocortin receptor-1 (MC1r) agonist peptides are for treatment of inflammatory and dermatologic disease indications. The company has selected one of its MC1r peptide drug candidates, designated PL-8177, as a clinical trial candidate. Strategy Main elements of the company’s business strategy include the following: using technology and expertise to develop and commercialize products in its active drug development programs; entering into strategic alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the company is developing; partially funding its product development programs with the cash flow generated from research collaboration and license agreements and any potential future agreements with third parties; and completing development and seeking regulatory approval of bremelanotide for FSD and its other product candidates. Intellectual Property Patent Protection The company owns two issued United States patents claiming the bremelanotide substance and an issued patent claiming the bremelanotide substance in each of Australia, Austria, Belgium, Brazil, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Korea, Luxembourg, Mexico, Monaco, the Netherlands, New Zealand, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. The company has patents and patent applications on an alternative class of melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications, including obesity, consisting of two issued patents in the United States, an issued patent in each of Australia, Canada, China, Russia, Japan, and New Zealand, and pending patent applications on the same class in Brazil, India, Israel, Korea, Mexico, and South Africa and before the European patent office. The company also has patents and pending patent applications for a second class of alternative melanocortin receptor-specific peptides for treatment of sexual dysfunction and other indications, including obesity, consisting of issued patents in the United States, Australia, China, New Zealand, Russia, and South Africa and pending patent applications on the same class in Brazil, Canada, China, India, Israel, Japan, Korea, Mexico and before the European patent office. The company owns issued patents in the United States, New Zealand and South Africa claiming a narrow class of highly selective MC1r agonist peptides for treatment of inflammation-related diseases and disorders and related indications, and pending patent applications on two broader classes of highly selective MC1r agonist peptides in the United States, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, and Mexico and before the European and Eurasian patent offices. The presumptive term of the issued patents and pending patent applications is until 2030. The company owns an issued United States patent claiming the PL-3994 substance and other natriuretic peptide receptor agonist compounds that the company has developed and an issued United States patent claiming a precursor molecule to the PL-3994 substance, both of which expire in 2027. Corresponding patents on the PL-3994 substance and other natriuretic peptide receptor agonist compounds were issued in Australia, Austria, Belgium, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, the Netherlands, Philippines, Russia, South Africa, Spain, Sweden, and Switzerland, with terms until 2027. The company also owns an issued United States patent claiming use of the PL-3994 substance for treatment of acute asthma and chronic obstructive pulmonary disease, which expires in 2031. The company additionally has 29 issued United States patents on melanocortin receptor specific peptides and small molecules. Research and Development The company’s research and development expenses included approximately $24.6 million for the fiscal year ended June 30, 2015. Regulations The products the company is developing are subject to federal regulation in the United States, principally by the United States Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and by state and local governments, as well as regulatory and other authorities in foreign governments that include rigorous preclinical and clinical testing and other approval procedures. History Palatin Technologies, Inc. was founded in 1986. The company was incorporated in Delaware in 1986.
palatin technologies inc (PTN:NYSE Amex)
4B Cedar Brook Drive
Cranbury, NJ 08512
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