PDUFA Target Action Date March 23, 2019
Triggers Milestone Payment to Palatin of $20 Million
CRANBURY, N.J., June 4, 2018 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced today that the U.S. Food and Drug Administration (FDA) has accepted the bremelanotide New Drug Application (NDA) for filing. The NDA was filed on March 23, 2018 by AMAG Pharmaceuticals, the Company’s exclusive North American licensee. Bremelanotide, an investigational melanocortin agonist, is being developed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the bremelanotide NDA is March 23, 2019. If approved, bremelanotide would become the first and only as-desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.
The FDA’s acceptance of the NDA triggers a $20 million milestone payment to Palatin under its license agreement with AMAG Pharmaceuticals, less agreed upon deductions for expenses incurred by AMAG. Under the terms of the agreement, signed in January 2017, Palatin is entitled to receive up to $80 million contingent upon achieving certain regulatory milestones, consisting of $20 million upon the acceptance of the NDA filing by the FDA and up to $60 million upon regulatory approval by the FDA. Palatin is also entitled to receive tiered royalties on net sales ranging from high single-digit to low double-digit percentages and up to $300 million contingent upon meeting certain sales milestones.
“We are very pleased with the FDA’s acceptance of the NDA filing for bremelanotide,” said Carl Spana, Ph.D., CEO and President of Palatin. “This is an important milestone for Palatin and reflects our drive and commitment to the development of novel therapies to treat conditions with significant unmet medical need and commercial potential. We look forward to assisting AMAG during the FDA review process. HSDD is an underserved medical condition and, if approved, bremelanotide has significant potential as an as-desired treatment of HSDD in premenopausal women.”
In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting to discuss this application. The Company will announce the date of the Advisory Committee meeting when it is scheduled.
Palatin previously announced positive results for two Phase 3 trials of bremelanotide for the treatment of HSDD in premenopausal women that met the pre-specified co-primary efficacy endpoints.
About Hypoactive Sexual Desire Disorder (HSDD)
HSDD, the most common type of female sexual dysfunction, affects approximately 12 million women in the U.S. The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues.1 Approximately 6 million pre-menopausal women meet the diagnosis for acquired, generalized HSDD.2 Patient awareness and understanding of the condition remains low, and few women currently seek or receive treatment. Recent industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from HSDD are unaware that it is a treatable medical condition.3
Bremelanotide, an investigational product, is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
The Phase 3 RECONNECT studies for HSDD in premenopausal women consisted of two double-blind placebo-controlled, randomized parallel group studies comparing the as desired use of 1.75 mg of bremelanotide versus placebo, in each case, delivered via a subcutaneous 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 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.
In the Phase 3 clinical trials, the most frequent adverse events were nausea, flushing, and headache, which were generally mild-to-moderate in intensity and were transient.
About Palatin Technologies
Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases and conditions 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.
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about potential actions by regulatory agencies relating to bremelanotide, potential labels and indications for bremelanotide, whether FDA will provide regulatory approval for bremelanotide, whether AMAG will be successful in developing and commercializing bremelanotide in the United States, 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, 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.
1 Shifren et al, Sexual Problems and Distress in United States Women; Obstetrics & Gynecology, Vol. 112, No. 5, November 2008; 2014 U.S. Census data
2 Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016
3 Patient & Economic Flow Study sponsored by Palatin Technologies, Inc. and conducted by Burke Institute, April 2016
SOURCE Palatin Technologies, Inc.