Roche currently markets daclizumab for induction transplant therapy as Zenapax. Roche and Protein are developing a new subcutaneous daclizumab (daclizumab s.c.) formulation for use in phase II clinical trials expected to start in 2006.
Currently, transplant patients are treated with the combination therapy of Roche’s CellCept (mycophenolate mofetil) with a calcineurin inhibitor such as cyclosporine and steroids to prevent organ rejection. However, the long-term use of the current calcineurin inhibitors can cause kidney toxicity, diabetes and cardiovascular disorders.
Using daclizumab s.c. as maintenance treatment in combination with CellCept may allow for the reduction, and potential elimination, of the more toxic drugs from transplant patient maintenance regimens.
Roche and Protein have amended their current agreements to reflect the scope of daclizumab s.c.’s further development. Under the terms of this agreement, Protein will receive a $10 million upfront payment and may be eligible to receive payments up to $145 million if certain milestones are satisfied and if the indication is successfully developed.
Roche will continue to manufacture and promote Zenapax exclusively on a worldwide basis. Both companies will share equally global development costs, and Protein has the option to co-promote daclizumab s.c. for transplant maintenance in the US.