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 III clinical data required for approval of bremelanotide for female sexual dysfunction in the EU.
An extension to 30 April 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 $1.0m, non-refundable option fee under the option agreement.
Palatin president and CEO Dr Carl Spana noted that the company believes that the two largest potential markets for bremelanotide as a treatment for FSD are the US and the EU, and that the most effective strategy is to have separate partners for each region.
"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," Dr Spana added.