Roche/Protein Design Labs will pursue a broad moderate to severe asthma indication for Zenapax (daclizumab) under a co-development agreement announced Sept. 16.

The worldwide agreement covers development and commercialization of Zenapax "for asthma and related respiratory diseases." Roche currently markets Zenapax for prevention of organ rejection in patients receiving renal transplants.

PDL will receive $17.5 mil. upfront and could receive up to $187.5 mil. in milestones. PDL, which licensed daclizumab to Roche, reacquired rights to all non-transplantation indications in September 2003 for $80 mil., with an option to add the transplantation indications in 2007.

The firms are initially targeting an indication for treatment of moderate to severe persistent asthma; the agreement is based on positive Phase II data in that indication that was reported in March.

A moderate to severe persistent asthma indication would be a broader indication than that carried by Genentech/Novartis' monoclonal antibody Xolair (omalizumab), which is indicated for use in allergic patients with moderate to severe asthma.

In addition to the potential for a broader indication, Chief Medical Officer Steven Benner, MD, pointed to several other advantages over Xolair during a Sept. 16 conference call. PDL is developing a subcutaneous formulation that does not require reconstitution, he noted, and "we do not have to test for allergy nor adjust the dose based on IgE levels."

Going forward, a Phase I trial of subcutaneous daclizumab in healthy volunteers is expected to begin by the fourth quarter 2004, and a Phase IIb dose-ranging study in asthmatics is slated for the third quarter of 2005.

Zenapax is PDL's second highest priority after the firm's Nuvion for ulcerative colitis, CEO Mark McDade told investors.

"Because of the patient needs and the potential size of the market, the continued development of daclizumab in asthma is among PDL's highest clinical development priorities, second only to Nuvion," he said.

PDL discontinued development of daclizumab for ulcerative colitis in May following a failed Phase II study (¹ Also see "Protein Design Labs Discontinues Daclizumab Development For Colitis; Asthma Is “Top Priority” Indication" - Pink Sheet, 17 May, 2004.).

The firm is conducting an ongoing, open-label Phase I/II study of Nuvion (visilizumab) in patients with severe ulcerative colitis whose disease has not responded to treatment with intravenous steroids.

- Lee Szilagyi

PDL/Roche Targeting Broad Zenapax Asthma Indication Under Development Deal

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