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.
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SOURCE Palatin Technologies, Inc.