Biogen Idec will leverage its multiple sclerosis and oncology franchises to co-develop Protein Design Labs' daclizumab and volociximab for MS and cancer applications under a deal worth up to $800 mil.

The deal, announced Aug. 2, also includes PDL's HuZaf (fontolizumab) for a variety of autoimmune diseases.

All three agents currently are in Phase II studies, including an MS trial with daclizumab.

Daclizumab is marketed by Roche as Zenapax for prevention of organ rejection in patients receiving renal transplants. After licensing the interleukin-2 antibody to Roche, PDL reacquired rights for all non-transplantation indications in September 2003.

Roche subsequently gained rights to asthma and related respiratory disease applications under a September 2004 co-development deal (¹ Also see "PDL/Roche Targeting Broad Zenapax Asthma Indication Under Development Deal" - Pink Sheet, 16 September, 2004.).

The Biogen Idec agreement includes all daclizumab applications other than transplant and respiratory diseases.

A failed Phase II study caused PDL to discontinue development of daclizumab for ulcerative colitis in May 2004 (² Also see "Protein Design Labs Discontinues Daclizumab Development For Colitis; Asthma Is “Top Priority” Indication" - Pink Sheet, 17 May, 2004.).

Biogen Idec's MS franchise includes Avonex (interferon beta-1a), which generated 2004 sales of $1.42 bil.

The firm is continuing its work to bring Tysabri (natalizumab) back to market for MS following its voluntary withdrawal in February due to safety concerns (³ Also see "Biogen Idec Refocusing On U.S. Avonex Sales While Awaiting Tysabri's Fate" - Pink Sheet, 27 July, 2005.).

Biogen Idec maintains the daclizumab effort is unrelated to its Tysabri strategy.

MS "is a lifelong disease and people afflicted with [the disease] are likely to use a number of products developed by Biogen over their lifetime," CEO Jim Mullen said during a same-day conference call.

"This partnership will expand our oncology presence in solid tumors, while strengthening our position as a leader in [MS] research and development."

Volociximab, also known as M200, is in Phase II trials for renal cell carcinoma, melanoma and pancreatic cancers. An additional Phase II study in non-small cell lung cancer is slated to begin in August.

The interferon-gamma antibody fontolizumab is in Phase II for Crohn's disease; PDL is planning a pilot study in rheumatoid arthritis.

Under the terms of the deal, PDL will receive $40 mil. up front and Biogen Idec will purchase $100 mil. in PDL stock. PDL also could receive up to $660 mil. in milestone payments under the agreement.

Biogen Idec and PDL will share development costs and profits, and will have co-promotion rights in the U.S. and Europe.

- Jon Dobson

Biogen Idec Gains Phase II MS, Cancer Biologics Through PDL Deal

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