Swiss giant Roche this morning said it has signed an expanded deal with partner Protein Design Labs for the antibody therapy daclizumab in a new indication, for organ transplant patients receiving long-term maintenance therapy. Roche already sells daclizumab as Zenapax for initial use in organ transplant patients.

Currently, patients on long-term therapy are given Roche’s Cellcept (mycophenolate mofetil) plus a calcineurin inhibitors such as cyclosporine or steroids. However, such long-term use of calcineurin inhibitors is linked to kidney toxicity, diabetes and cardiovascular disorders, says the firm, a side effect that is significantly reduced or eliminated by the combination of Zenapax plus CellCept.

As part and parcel of this new development, Roche and PDL plan to develop a subcutaneous version of Zenapax, with Phase II trials expected to begin next year. Said Peter Hug, Roche’s Global Head of Pharma Partnering: “With the potential to use CellCept and daclizumab sc as the centrepiece for long-term transplant therapy, we could offer patients a safer, more tolerable option.”

Under the terms of the deal, PDL will receive an additional $10 million in upfront payment and up to $145 million on completion of certain milestones. The US biopharmaceutical company has also agreed to give up its option to promote Zenapax in acute kidney transplant rejection, which would otherwise come into effect in 2007.

Roche and PDL are also exploring the use of daclizumab in asthma and other respiratory diseases, while PDL also has links with Biogen Idec for daclizumab in multiple sclerosis [[16/09/04h]], [[04/08/05b]].