Palatin's Vyleesi® Licensee Fosun Pharma Reports First Commercial Sale in China and South Korean Licensee Kwangdong Pharmaceuticals Completes Enrollment in Phase 3 Clinical Study
- First sale of Vyleesi in China reported, strengthening position in Asian marketplace
- Phase 3 trial in South Korea completed with 93% of patients enrolled
- Data from trial expected by year end, potential regulatory submission in first half of 2024
- None.
- 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) inSouth Korea - Data expected later this year
- Supports submission to Korean Ministry of Food & Drug Safety (MFDS) for Marketing Approval
Vyleesi is the first and only as-needed treatment approved by the
"We are excited by this significant achievement and advancement of Vyleesi in HSDD patients in
Fosun's first sale of Vyleesi was dispensed through a medical institution in the
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
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
Under the terms of the 2017 agreement with Kwangdong, Palatin granted Kwangdong an exclusive license to develop and commercialize bremelanotide (Vyleesi) in the
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
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.