, May 1, 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 need and commercial potential, announced that a potential commercial partner has exercised its option for an exclusive license to bremelanotide for female sexual dysfunction (FSD) indications in the European Union and other European countries.
The option grants the potential commercial partner an exclusive, time-limited right to negotiate, in good faith, the terms of a definitive license agreement with respect to development, distribution and marketing of bremelanotide.
The option agreement is with a European specialty pharmaceutical company with drug manufacturing, research and development, and sales and marketing capabilities. As part of the option agreement, the parties sought and received clear regulatory advice from the European Medicines Agency (EMA) on the phase 3 clinical data required for approval of bremelanotide for female sexual dysfunction in the European Union. An extension to April 30, 2014 was granted to allow the potential optionee to complete its comprehensive market assessment, including qualitative and quantitative surveys, in selected countries. Palatin previously received a $1.0 million, non-refundable option fee under the option agreement.
"We believe that the two largest potential markets for bremelanotide as a treatment for FSD are the United States and the European Union, and that the most effective strategy is to have separate partners for each region," stated Carl Spana, Ph.D., President and CEO of Palatin. "We are extremely pleased with the commitment and expertise of our potential European partner and excited to be entering into discussions on a definitive license agreement. We are also in active discussions with multiple pharmaceutical companies to commercialize bremelanotide in the United States."
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.
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.
SOURCE Palatin Technologies, Inc.