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Biotech / Medical : HuMAB companies

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From: Icebrg8/2/2005 4:19:30 PM
   of 1022
 
Biogen Idec and PDL Form Global Alliance to Develop and Commercialize Three Phase II Antibody Products
Tuesday August 2, 4:03 pm ET
Agreement Covers Daclizumab for Multiple Sclerosis; M200 and HuZAF(TM) in Multiple Indications
Companies to Conduct Conference Call and Webcast at 4:30 p.m. Eastern Time

[There is gold in those mAbs, evidently. A good move for PDLI. We'll see if there is any carry-over of good feelings to MEDX and ABGX tomorrow].

CAMBRIDGE, Mass. and FREMONT, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Biogen Idec (Nasdaq: BIIB - News) and Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) today announced a broad collaboration for the joint development, manufacture and commercialization of three Phase II antibody products. The agreement provides for shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases, and for shared development and commercialization of M200 (volociximab) and HuZAF(TM) (fontolizumab) in all indications.

Under terms of the agreement, PDL will receive an upfront payment of $40 million, and Biogen Idec will purchase $100 million of common stock from PDL. If multiple products were developed successfully in multiple indications and all milestones were achieved, PDL could receive certain development and commercialization milestone payments totaling up to $660 million. Of these, $560 million are related to development and $100 million are related to commercialization of collaboration products.

Biogen Idec and PDL will share equally the costs of all development activities and all operating profits from each collaboration product within the United States and Europe. The companies will jointly oversee development, manufacturing and commercialization plans for collaboration products and intend to divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the United States and Europe. Outside the United States and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.

"We are very pleased to forge a comprehensive global collaboration on these three products with PDL," said Jim Mullen, President and CEO of Biogen Idec. "This partnership will expand our oncology presence in solid tumors, while strengthening our position as a leader in multiple sclerosis research and development."

Mark McDade, Chief Executive Officer, PDL, said, "As a world leader in the treatment of multiple sclerosis and the originator of the successful cancer treatment, Rituxan® (rituximab), we believe Biogen Idec is an outstanding partner with whom to globally develop and commercialize these three novel antibody products. We are obviously excited to forge this collaboration that advances our pipeline, accelerates our path to sustainable positive cash flow and paves the way to commercialization of the next wave of PDL products. From our perspective, this alliance enables both companies to share costs and risks of developing products that address large market opportunities, while leveraging our respective development, manufacturing and commercial strengths."

The closing of the transaction, including the stock purchase, will be subject to antitrust review and approval, and other standard closing conditions. The purchase of the stock will be at fair market value. The stock purchase agreement also provides for a registration statement to be filed for the common stock and the re-sale of the stock is subject to certain limitations.

About Daclizumab

Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune and related diseases. A Phase II clinical trial of daclizumab in multiple sclerosis is ongoing. Rights to daclizumab in transplantation, asthma and related respiratory diseases are in partnership with Roche.

About M200 (volociximab)

Volociximab is a novel anti-angiogenic chimeric antibody directed against alpha5 beta1 integrin. Binding of the antibody to alpha5 beta1 integrin inhibits the formation of new blood vessels, a process necessary for tumor growth. Results from a Phase I study in advanced solid tumors suggest that volociximab was well tolerated and did not identify dose-limiting toxicities. Three Phase II clinical trials of volociximab in renal cell carcinoma, melanoma and pancreatic cancers were initiated in the first half of 2005. A fourth Phase II study in non-small cell lung cancer is anticipated to begin shortly. Preclinical data with volociximab suggest the antibody may also have potential as a treatment for age-related macular degeneration.

About HuZAF(TM) (fontolizumab)

Fontolizumab is a humanized antibody that binds to interferon-gamma, an important immunoregulatory cytokine with multiple activities, including up- regulation of MHC Class II molecule expression. Blocking interferon-gamma may be useful in treating a variety of autoimmune diseases.
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