CRANBURY, N.J., Dec. 29, 2014 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program. The Company has initiated its phase 3 reconnectstudy in the United States for the treatment of female sexual dysfunction (FSD).
"We are pleased to achieve this major milestone in the bremelanotide program with the initiation of our phase 3 reconnectstudy in the U.S," stated Carl Spana, Ph.D., President and CEO of Palatin. "This is a key step in our global strategy to bring bremelanotide to market for the millions of women who have FSD and are seeking a safe and effective treatment." Dr. Spana further stated that, "Our recent $30 million financing has provided the financial resources to start the bremelanotide phase 3 pivotal registration program and timing flexibility regarding partnering for the U.S. and other non-European territories."
The start of the reconnect study phase 3 clinical trial in the U.S triggers a development milestone payment of €2.5 million (~$3 million) from Gedeon Richter Plc, Palatin's partner in Europe for bremelanotide for FSD. Palatin is also eligible to receive regulatory and sales milestones, and low double-digit royalties on net sales in the European licensed territory.
Protocol 301 of the reconnectstudy is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. It is designed to randomize approximately 550 women in North America to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment. Initial data from the study is anticipated in the middle of calendar year 2016. More information on the trial protocol, including trial design, inclusion/exclusion criteria, etc., can be found at http://clinicaltrials.gov.
About Bremelanotide for Female Sexual Dysfunction Palatin is developing bremelanotide subcutaneous for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
About Female Sexual Dysfunction Female Sexual Dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We will seek approval of bremelanotide for the largest category of FSD, hypoactive sexual desire disorder. To establish a diagnosis of FSD, one or more of the disorders making up FSD must be associated with personal distress, as determined by the affected women.i A study of more than 30,000 U.S. women in 2008 reported an age-adjusted point prevalence of sexual difficulties causing personal distress in 12 percent of respondents.ii
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand, as-needed treatment and has the potential to transform the treatment of patients with FSD.
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 http://www.palatin.com.
About Gedeon Richter Gedeon Richter (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter's consolidated sales were approximately EUR 1.2 billion (USD 1.6 billion) while its market capitalization amounted to EUR 2.8 billion (USD 3.8 billion) in 2013. The product portfolio of Richter covers almost all important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the female healthcare field worldwide. Richter is also active in biosimilar product development.
Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about the prospects of entering into one or more license agreements in European countries or other regions relating to bremelanotide, potential clinical trial results with bremelanotide, potential actions by regulatory agencies in the United States or Europe relating to bremelanotide, regulatory plans, development programs and the market potential of 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, the ability of Palatin to enter into one or more agreements relating to the commercialization of bremelanotide, results of nonclinical, preclinical and toxicology studies, result of clinical trials, regulatory actions by the FDA and other regulatory agencies 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.
i Frank J et al. Diagnosis and Treatment of Female Sexual Dysfunction. AmFam Physician 2008; 77(5): 635-642. ii Shifren JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. ObstetGynecol 2008;112 (5); 968-9.