As part of the agreement Schering-Plough will be responsible for all forward research and development activities, including clinical studies and regulatory filings, continuing its focus on developing hepatitis treatments and targeted oral antiviral agents.
Valeant licensed pradefovir from Metabasis in 2000 and has been conducting clinical trials to evaluate the safety and efficacy of pradefovir for compensated chronic hepatitis B. Pradefovir is a pro-drug of PMEA that uses Metabasis’ HepDirect technology to enable higher concentrations of the drug in the liver, the primary site of replication for the hepatitis B virus, and lower concentrations elsewhere in the body.
Under the terms of the agreements, Schering-Plough will make upfront payment of $19.2 million to Valeant and $1.8 million to Metabasis and will pay additional fees upon the achievement of certain development and regulatory milestones. Schering-Plough will also pay royalties to in the event that pradefovir is commercialized. The transaction is expected to close in the first quarter of 2007.