CRANBURY, N.J., Nov. 21, 2017 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN; "Palatin") announced today that it has entered into a collaboration and license agreement with Kwangdong Pharmaceutical Co., Ltd. ("Kwangdong"), for exclusive rights to develop and commercialize bremelanotide for female sexual dysfunction (FSD) indications in the Republic of Korea. Kwangdong, based in Seoul, Korea, is a leading Korean pharmaceutical company with annual sales of approximately $919 million in 2016. A New Drug Application (NDA) is anticipated to be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of calendar year 2018.
"We are extremely pleased to have Kwangdong as our partner for bremelanotide in Korea," stated Carl Spana, Ph.D., President and CEO of Palatin. "Kwangdong's significant resources and commercial capabilities are uniquely suited to raise awareness and understanding of HSDD and the potential benefits of bremelanotide to health care providers and patients in Korea. We look forward to working closely with Kwangdong to assist them in obtaining regulatory approval and have a successful commercial launch of bremelanotide in Korea."
Sung-Won Choi, President and CEO of Kwangdong, commented, "We are pleased to partner with Palatin and further the advancement of the bremelanotide program for the treatment of female sexual dysfunction in Korea. We believe that Palatin's bremelanotide, as a niche market product, has tremendous potential. Our strong marketing and sales capabilities and established relationships with opinion leaders make us an ideal partner to introduce bremelanotide, innovative and first-in-class compounds, to the Korean marketplace."
Under the terms of the agreement, Palatin has granted Kwangdong an exclusive license to develop and commercialize bremelanotide in the Republic of Korea for FSD. Kwangdong will be responsible for all regulatory and other development and clinical activities necessary for commercialization in the Republic of Korea. In exchange, Palatin will receive an upfront payment of $500,000 and a $3.0 million milestone based on first commercial sale in Korea. Palatin has the potential to receive up to $37.5 million in sales related milestones and mid-single-digit to low double-digit royalties on net sales in the licensed territory.
Palatin announced in February 2017 that it entered into an agreement with AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) granting AMAG exclusive North American rights to develop and commercialize bremelanotide and in September 2017 announced that it entered into an agreement with Fosun Pharma granting Fosun exclusive rights to develop and commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong S.A.R. and Macau S.A.R. A New Drug Application (NDA) is anticipated to be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of calendar year 2018.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects approximately 15 million women in the U.S. and is characterized by low sexual desire that causes marked distress or relationship anxiety. Approximately 5.8 million pre-menopausal women have a primary diagnosis of HSDD. Patient awareness and understanding of the condition remain extremely low, and few women currently seek treatment. Recent market research indicates that 95 percent of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition. Furthermore, the majority of these women indicated a willingness to try a product like bremelanotide, if recommended by their doctor.
Bremelanotide, an investigational drug product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
The two Phase 3 studies for HSDD in pre-menopausal women consisted of double-blind placebo-controlled, randomized parallel group studies comparing a single use, subcutaneous dose of 1.75 mg of bremelanotide versus placebo, in each case, delivered via an auto-injector. Each trial consisted of more than 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo with a 24-week evaluation period. In both clinical trials, bremelanotide met the pre-specified co-primary efficacy endpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments.
Women in the trials had the option, after completion of the trial, to continue in an ongoing open-label safety extension study for an additional 52 weeks. Nearly 80% of patients who completed the randomized portion of the study elected to remain in the open-label portion of the study, and all of these patients will continue to receive bremelanotide.
In both Phase 2 and Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in severity.
Bremelanotide has no known alcohol interactions.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics 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 in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com.
About Kwangdong Pharmaceutical Co., Ltd.
Established in 1963 and headquartered in Seoul, Korea, Kwangdong Pharmaceutical Co., Ltd. is a leading Korean-based Pharmaceutical company. The company reported approximately $919 million in annual sales in 2016. Kwangdong has more than 500 sales representatives in Korea. The company has a wide range of business segments with the aim of improving human health.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results with bremelanotide, potential actions by regulatory agencies relating to bremelanotide, potential labels and indications for bremelanotide, and market potential for bremelanotide 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 nonclinical, preclinical and toxicology studies, result of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, regulatory actions by the USPTO, 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.
References Regarding HSDD
U.S Census Bureau, 2014
Shifren et all, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008
U.S. Census Bureau, 2015 American Community Survey 1-Year Estimates
Mayo Clinic Proceedings: "Hypoactive Sexual Desire Disorder: International Society for the Study of Women's Sexual Health (ISSWSH) Expert Consensus Panel Review," Volume 92, Issue 1, January 2017
Burke Institute: Patient and Economic Flow Study, April 2016
Burke Institute: Patient Segmentation Insights, August 2016
SOURCE Palatin Technologies, Inc.