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Application Could Provide U.S. and International Patent Coverage for PL9643, Palatin's Lead Compound for Dry Eye Disease
Phase 2/3 Clinical Trial Currently Planned for Mid-2021
CRANBURY, N.J., Feb. 10, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced the filing of an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides.
Palatin recently reported positive results in its Phase 2 study of PL9643 for the treatment of Dry Eye Disease (DED). Detailed study results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. A Phase 2/3 clinical trial with PL9643 for the treatment of DED is currently planned for mid-2021.
The PCT application for PL9643 establishes the base for the presumptive patent term, and if a patent is granted which claims priority to this application, could provide patent protection for PL9643, and any product in which PL9643 is the active pharmaceutical ingredient, out to 2041, excluding any additional term for patent adjustment or patent term extension.
Palatin believes that the structure of PL9643 is novel and inventive. The International Search Authority will conduct a search and issue its Written Opinion on PL9643 and the related family of melanocortin agonist peptides, which will provide additional information on patentability of PL9643 and the related family. We anticipate filing patent applications in the United States, Europe and a number of additional regions and countries throughout the world.
About Dry Eye Disease (DED)
Dry eye disease is a common inflammatory disease that, left untreated, can become extremely painful and lead to permanent damage to the cornea and vision. Dry eye disease affects the cornea and conjunctiva of the eye resulting in irritation, redness, pain, and blurred vision. It is estimated to affect over 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Existing therapy for dry eye disease is generally regarded as inadequate by many physicians and patients, and often requires weeks or months to demonstrate activity.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about patentability of PL9643 and the related family of melanocortin agonist peptides, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, market potential for product candidates, and potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, 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. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, actions by patent offices in the United States and other countries, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.
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SOURCE Palatin Technologies, Inc.