DURECT, Nycomed amend POSIDUR Development and License Agreement

DURECT Corporation (Nasdaq: DRRX) announced today that Nycomed and DURECT have amended the Development and License Agreement entered into between the parties in 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.

The amendment provides DURECT with final decision-making authority over clinical trials intended for the U.S. registration of POSIDUR and Nycomed with decision-making authority over clinical trials for the E.U. and other countries licensed to it. DURECT will have funding responsibility for all current and future clinical trials intended for U.S. registration of POSIDUR and, commencing April 1, 2010, Nycomed will have sole funding responsibility for all clinical trials intended for E.U. 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. The amendment further expands the territories licensed to Nycomed to include China, Hong Kong, Malaysia, Philippines, Singapore, Taiwan, Vietnam, Thailand, Indonesia, India and Venezuela. DURECT retains full ownership of POSIDUR in the U.S., Canada, Japan and other territories not granted to Nycomed.

"Nycomed has been a strong partner for DURECT since the inception of our relationship, and the early portions of the U.S. and E.U. development programs have benefited from the joint guidance and co-funding by the parties. However, at this later stage of development, given the divergence between the clinical development programs required for regulatory approval as between the U.S. and E.U., and our aspirations to partner POSIDUR in the U.S., this amendment provides greater flexibility for both parties in their respective territories while at the same time preserving the close cooperation and sharing of data for our mutual benefit," stated James E. Brown, President and CEO of DURECT Corporation. "We also believe that Nycomed will diligently exploit the additional countries granted to them, from which we will benefit under the same favorable commercial terms as in our original agreement."

DURECT recently commenced BESST (Bupivacaine Effectiveness and Safety in SABER™ Trial), which is intended to be the pivotal Phase III clinical trial in the U.S. In Europe, Nycomed is currently conducting two Phase IIb clinical trials (in hysterectomy and in shoulder surgery) with OPTESIA™.

SOURCE DURECT Corporation