FP01 is already marketed as an oral drug product in a disease unrelated to cough, has been administered chronically to more than 4.5 million patients worldwide and in 2010 generated US revenues well in excess of $1.2 billion. Given its unique mechanism of action, FP01 has a clinical profile that is remarkable for the absence of adverse effects and the abuse liability that plague currently available antitussives. The currently marketed form of FP01 has a long lag time to peak effect - limiting its potential utility in acute cough. Our intellectual property portfolio consists of patent applications which cover cough method-of–use, in addition to synergistic combinations and cough formulations of FP01 which enable its utility in cough and provide the opportunity to build a patented portfolio of new cough and cold products. By license agreement with JHMI, Cerecor possesses the exclusive worldwide rights to develop and market FP01 in cough, and itself owns the formulation and combination IP. We have recently demonstrated that FP01 is an extremely potent antitussive in animals, much more than the ubiquitous cough drug dextromethorphan and produces no observable signs of sedation or behavioral changes, unlike dextromethorphan.
FP01 represents a rare opportunity to develop and commercialize a platform of new treatments for cough within a short period of time. We intend to register multiple improved FP01 cough products using our patented cough formulations focusing on product enhancement and on filling unmet patient needs: fast acting melts, cough syrup and combination cough and cold products.