Roche and Protein Design Labs (PDL) announced a worldwide agreement to co-develop and commercialize Zenapax (daclizumab) for asthma and related respiratory diseases, based on recent positive phase II data in patients with moderate to severe asthma.
Under terms of the agreement, PDL will receive a $17.5 million upfront payment as well as up to $187.5 million in development and commercialization milestones for successful further development of daclizumab. Roche and PDL will globally co-develop daclizumab in asthma, share development expenses and co-promote the product in the US. Outside the US, PDL will receive royalties on net sales of the product in asthma.
"This new agreement will strengthen our pipeline in asthma, where we are currently in phase II development of a novel oral treatment," said William M Burns, head of Roche's Pharmaceuticals Division. He added, "We believe that daclizumab will offer patients a significant improvement over today's current therapy. Our long-standing relationship with PDL continues to grow as we develop daclizumab further."
Mark McDade, CEO, PDL, said, "The continued development of daclizumab in asthma is among PDL's highest clinical development priorities. With Roche as our ongoing partner in this indication, we believe daclizumab will obtain the resources needed to develop the full potential of this humanized antibody in asthma."
In 1989, Roche acquired the worldwide rights to daclizumab, a product that has since gained an important position within Roche's transplantation portfolio. In September 2003, Roche resold to PDL all rights to daclizumab, except in transplantation, until 2007 when PDL will have the option to re-acquire the transplantation rights as well. In 2004, PDL approached Roche with compelling phase II data for daclizumab in asthma, leading to today's announcement for the continued co-development of daclizumab in respiratory disorders by Roche and PDL.
Protein Design Labs is involved in developing humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its antibody humanization technology.