DURECT and Nycomed amend Posidur deal to separate funding and control of US and EU clinical programs

Switzerland-headquartered Nycomed and the USA's DURECT have amended the licensing agreement entered into between the parties in November 2006 covering the development and commercialization of Posidur (also known as Saber [bupivacaine] or Optesia), an investigational drug for the treatment of post-surgical pain.

Nycomed bought the exclusive commercialization rights to Posidur in the European Union and select other countries in a deal under which DURECT is eligible to receive future milestone payments from Nycomed of up to $181 million on achievement of defined development, regulatory and sales milestones

The amendment provides DURECT with final decision-making authority over clinical trials intended for the US registration of Posidur and Nycomed with like rights for the EU and other countries licensed to it. DURECT will have funding responsibility for all current and future clinical trials intended for US registration, commencing April 1, 2010, Nycomed will have sole funding responsibility for all clinical trials intended for EU registration of Optesia (Nycomed's brand name for this drug candidate). The parties are not altering the final decision making authority and financial responsibility for the remainder of the development activities, such as the non-clinical and CMC activities, which will continue to be jointly managed and funded by DURECT and Nycomed.