KemPharm, Johnson Matthey Sign Supply Agreement For Acute Pain Prodrug KP201

As per the terms of the agreement, KemPharm will be responsible for drug product, preclinical and clinical studies, along with regulatory filings, while Johnson Matthey will be responsible for manufacturing API for the development and commercialization of KP201.

KemPharm’s KP201 is composed of hydrocodone attached to a ligand. Preclinical studies suggest that KP201 may exhibit abuse deterrent properties based on its physicochemical and pharmacological characteristics as compared with currently approved narcotic analgesics.

KemPharm expects to file an IND for KP201 in the second half of 2010 and may be able to use the 505(b)(2) regulatory pathway for a more rapid development timeline.

Travis Mickle, president and chief scientific officer of KemPharm, said: “We believe Johnson Matthey’s expertise and proven track record in the manufacture of controlled drug substances are a natural fit with our unique approach to improving drugs with high abuse potential that is based on creating inherently abuse resistant molecules through chemical modification.

“We are pleased to mark this milestone for KP201 keeping the program on track with our aggressive development timelines. Importantly, this agreement supports our plan to complete our IND filing for KP201 in the second half of 2010.”

Kate Holt, senior director of business development for KemPharm, said: “It is our belief that this risk-and-reward sharing partnership with Johnson Matthey signals an acknowledgement of the sizable upside potential in KP201 and further validates our LAT prodrug approach. KP201 represents the first of what we anticipate will be a franchise of diverse pain relief prodrugs that are going to emerge from our preclinical LAT pipeline.”