Roche, Protein Design Labs expand deal to develop daclizumab

By E. Janene Geiss

Philadelphia, Nov. 1 - Roche and Protein Design Labs, Inc. announced Tuesday an expansion to their partnership to co-develop and commercialize daclizumab for organ transplant patients on long-term maintenance therapy.

Roche and Protein Design Labs are developing a new subcutaneous daclizumab formulation (daclizumab s.c.), manufactured by Protein Design Labs for use in phase II clinical trials expected to start in 2006, according to a company news release.

Currently, transplant patients are treated with the combination therapy of Roche's CellCept with a calcineurin inhibitor such as cyclosporine and steroids to prevent organ rejection. But long-term use can cause kidney toxicity, diabetes and cardiovascular disorders.

Officials said 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 currently markets daclizumab for induction transplant therapy as Zenapax.

Roche and Protein Design Labs have amended their current agreements to reflect the scope of daclizumab s.c.'s further development. Under the terms, Protein Design Labs 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, officials said.

Roche and Protein Design Labs will share equally global development costs and Protein Design Labs has the option to co-promote daclizumab s.c. for transplant maintenance in the United States.

Protein Design Labs and Roche will continue with the co-development of daclizumab s.c. in respiratory disorders, as announced in September 2004.

Outside the United States, Protein Design Labs will receive royalties on net sales of the product in transplant maintenance.

As part of the arrangement, the parties agree that Protein Design Labs will not exercise its option to promote Zenapax for prevention of acute kidney transplant rejection and Protein Design Labs is no longer required to make the payment, which would otherwise be due in 2007 for such right.

Basel, Switzerland-based Roche is a pharmaceutical company. Fremont, Calif.-based Protein Design Labs is a biopharmaceutical company.

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