KemPharm, Inc. has entered into an exclusive supply agreement with Johnson Matthey Inc., for the manufacture of the active pharmaceutical ingredient (API), KP201, KemPharm’s novel hydrocodone prodrug for acute pain. KP201 was identified utilizing KemPharm’s proprietary ligand activated therapy (LAT) approach. In preclinical studies, KP201 exhibited unique abuse deterrent properties that may help address significant abuse liabilities of current marketed narcotic analgesics. Under 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.
“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,” commented Travis Mickle, Ph.D., President and Chief Scientific Officer of KemPharm. “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.” “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,” commented Kate Holt, Ph.D., Senior Director of Business Development for KemPharm. “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.”