- First prescription dispensed in Chinese Hainan Province
- 93% of patients enrolled completed the Phase 3 trial in
premenopausal patients with Hypoactive Sexual Desire Disorder
(HSDD) in South Korea
-
- Data expected later this year
- Supports submission to Korean Ministry of Food & Drug
Safety (MFDS) for Marketing Approval
CRANBURY, N.J., Aug. 8, 2023
/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
receptor system, today announced that Fosun Pharma, the licensee of
Vyleesi in China, reported its
first sale in the Hainan Province
of China. Palatin also announced
that their South Korean licensee, Kwangdong Pharmaceuticals,
completed enrollment in its Phase 3 clinical trial evaluating the
efficacy and safety of Vyleesi in premenopausal women with HSDD.
Data from this trial is anticipated by year end with a potential
regulatory submission in the first half of 2024.
Vyleesi® Licensee Fosun Reports First
Sale in China and S Korean
Licensee Kwangdong Completes Phase 3 Clinical
Study
Vyleesi is the first and only as-needed treatment approved by
the U.S. Food and Drug Administration (FDA) for premenopausal women
with acquired, generalized hypoactive sexual desire disorder
(HSDD). Vyleesi is marketed by Palatin in the U.S. and the Company
recently announced its sixth consecutive quarter of double-digit
growth in Vyleesi prescriptions dispensed.
"We are excited by this significant achievement and advancement
of Vyleesi in HSDD patients in China," stated Carl
Spana, Ph.D., President, and Chief Executive Officer of
Palatin. "This first commercial sale, coupled with the completed
enrollment in the Phase 3 clinical trial in South Korea, strengthens our position in the
Asian marketplace. After the Phase 3 data analysis is complete, we
will be working closely with Kwangdong on the potential marketing
application with the Korean regulatory authorities. We look forward
to increasing patient use in China, to the potential approval in
South Korea and expanding the
availability and use of Vyleesi worldwide."
Fosun's first sale of Vyleesi was dispensed through a medical
institution in the Hainan
Province, a free trade port in China, under which certain imported
pharmaceutical products can be sold in Hainan without first receiving registration
approval from the Chinese National Medical Products Administration
(NMPA). The establishment of the Hainan Free Trade Zone (FTZ) is
expected to further boost the medical tourism zone project and
leverage market opportunities created by the growing demand for
medical products and services.
Kwangdong's Phase 3 study is a bridging, multicenter,
randomized, double-blind, placebo-controlled, parallel-group trial
to evaluate the efficacy and safety of subcutaneously injected
bremelanotide in premenopausal women with hypoactive sexual desire
disorder (with or without decreased arousal). The study enrolled
193 patients with 180 or 93% completing the study. Results of the
study are currently expected later this year and the data will
support a potential first-half 2024 submission to the Korean
Ministry of Food & Drug Safety (MFDS) for potential marketing
approval.
Under the terms of the 2017 agreement with Fosun, Palatin
granted Fosun an exclusive license to develop and commercialize
bremelanotide (Vyleesi) in the territories of mainland China, Taiwan, Hong
Kong and Macau. Palatin received an upfront payment of
$5.0 million and is due a
$7.5 million milestone based on
regulatory approval by the Chinese National Medical Products
Administration (NMPA). Palatin has the potential to receive up to
$92.5 million in sales related
milestones and high single-digit to low double-digit royalties on
annual net sales in the licensed territory. All development,
regulatory, sales, marketing, and commercial activities and
associated costs in the licensed territory are the sole
responsibility of Fosun.
Under the terms of the 2017 agreement with Kwangdong, Palatin
granted Kwangdong an exclusive license to develop and commercialize
bremelanotide (Vyleesi) in the Republic of Korea for HSDD/FSD.
Kwangdong is responsible for all regulatory and other development
and clinical activities necessary for commercialization in the
Republic of Korea. In exchange, Palatin received an upfront payment
of $500,000 and is due a $3.0 million milestone based on the first
commercial sale in Korea. Palatin has the potential to receive up
to $37.5 million in annual sales
related milestones and mid-single-digit to low-double-digit
royalties on net sales in the licensed territory.
About Vyleesi® (bremelanotide injection) for
Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by
the FDA for premenopausal women with acquired, generalized
HSDD.
Palatin is actively seeking Vyleesi collaborations for
the United States and for
territories outside the currently licensed territories of
China and Korea. Vyleesi is
licensed to Fosun Pharma in China
and Kwangdong Pharmaceuticals in South
Korea.
Patients and healthcare providers can learn more about HSDD and
Vyleesi at www.vyleesi.com and www.vyleesipro.com.
About Palatin
Palatin is a biopharmaceutical
company developing first-in-class medicines based on molecules that
modulate the activity of the melanocortin 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 and follow
Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this
press release that are not historical facts, including statements
about future expectations of Palatin, such as statements about
Vyleesi licensees and activities, initiatives, results and
potential market, 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, 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 events that
occur after the date of this press release.
Palatin Technologies® and Vyleesi® are
registered trademarks of Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.