Palatin Announces U.S. Patent Term Extension for Vyleesi® (bremelanotide injection)

CRANBURY, N.J., May 4, 2021 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced that the United States Patent and Trademark Office (USPTO) issued Notices of Final Determination and Requirement for Election on a patent term extension for two U.S. patents covering the Vyleesi® (bremelanotide injection) drug substance, U.S. patents 6,579,968 and 6,794,489. The term of only one patent may be extended and will have an expiration date of June 25, 2025.

Vyleesi is the only on-demand drug approved by the U.S. Food and Drug Administration for treatment of hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause. For more information on Vyleesi, go to www.vyleesi.com.

The patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years as compensation for patent term lost during drug development and the FDA regulatory review process. An interim extension for a period of one year from the original expiration date of both patents of June 25, 2020, was granted by the USPTO in May 2020.  In the Notices of Final Determination issued by the USPTO, the maximum allowable five-year extension was granted.

Palatin has filed an Election to extend the patent term of U.S. patent 6,794,489.  This Vyleesi patent, which will now expire June 25, 2025, has claims to the bremelanotide composition of matter as well as methods for stimulating sexual response.

Additional United States patents and patent applications claim methods of treating HSDD and female sexual dysfunction with Vyleesi and have terms until November 2033.  Issued patents on methods of treatment using Vyleesi include U.S. patents 10,286,034, 9,700,592 and 9,352,013.

About Palatin

Palatin is a 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.

Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Palatin, such as statements about the market potential of Vyleesi and other Palatin products in development, 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.

SOURCE Palatin Technologies, Inc.