- Palatin to receive $12 million
upfront, plus sales-based milestones of up to $159 million
- Palatin's focus is solely on its development and clinical
pipeline based on the melanocortin receptor system
CRANBURY, N.J., Dec. 20, 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 the sale of Vyleesi® to Cosette
Pharmaceuticals, a US-based, speciality pharmaceutical company, for
up to $171 million, consisting of an
upfront purchase price of $12 million
plus contingent, sales-based milestone payments of up to
$159 million. Vyleesi is the first
and only as-needed treatment approved by the Food and Drug
Administration (FDA) for premenopausal women with acquired,
generalized hypoactive sexual desire disorder (HSDD).
"The divestiture of Vyleesi is consistent with our strategic
decision to concentrate on our robust development and clinical
pipeline," stated Carl Spana, Ph.D.,
President and Chief Executive Officer of Palatin. "Our focus now is
solely on developing novel therapeutics that modulate the
melanocortin receptor system. Our Phase 3 PL9643 clinical study for
dry eye disease has completed patient enrollment and treatment, and
we look forward to the availability of topline data results in the
near future. Our Phase 2 study of oral PL8177 in patients with
ulcerative colitis is expected to have an interim analysis readout
in the first quarter and topline trial results in the second
quarter of calendar year 2024."
"Vyleesi is an important product for the millions of women
suffering from HSDD. Cosette is committed to women's healthcare,
and we are pleased they will make Vyleesi a priority in their
current product portfolio," concluded Dr. Spana.
"Vyleesi is an important addition to our rapidly expanding
women's health platform," said Apurva
Saraf, President and Chief Executive Officer of Cosette.
"HSDD is the most prevalent form of female sexual dysfunction,
affecting approximately six million premenopausal women in the U.S.
Through this acquisition, our mission is to give hope, support, and
a safe and effective treatment option for millions of women."
Under the terms of the asset purchase agreement with Cosette,
Palatin will receive $12 million
upfront. Palatin is also eligible to receive up to $159 million contingent upon the achievement of
sales milestones ranging from annual net sales of $15 million to $200
million. Palatin will transfer to Cosette all information,
data, and assets related exclusively to Vyleesi. Palatin will
provide certain transitional services to Cosette for a period of
time to ensure continued patient access to Vyleesi while Vyleesi is
operationally separated from Palatin. Cosette will reimburse
Palatin for the costs of the transition services. Palatin is also
eligible to receive regulatory approval milestones of $10.5 million associated with the previous
licensing of Vyleesi, consisting of $7.5
million related to Fosun for China and $3.0
million related to Kwangdong for S. Korea.
About Cosette Pharmaceuticals, Inc,
Cosette
Pharmaceuticals, Inc. ("Cosette") is a US-based, fully integrated
pharmaceutical company with a fast-growing portfolio of branded
pharmaceuticals consisting of products in women's health,
cardiology and dermatology. Cosette has a long history in quality
manufacturing of complex dosage forms including topical creams,
ointments, oral liquids/solutions and suppositories. Cosette has
corporate and manufacturing facilities in New Jersey and North
Carolina and is supported by 300+ dedicated employees across
all functional areas. Cosette is backed by Avista Capital Partners,
a healthcare focused private equity firm.
www.cosettepharma.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
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® is a registered trademark of
Palatin Technologies, Inc.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/palatin-completes-sale-of-vyleesi-to-cosette-pharmaceuticals-for-up-to-171-million-302020026.html
SOURCE Palatin Technologies, Inc.