Millennium and Protein Design Labs announce agreement for humanized antibody patent rights

Multiple Antibody Agreement Supports Later Stage Clinical Development

Millennium Pharmaceuticals, Inc. and Protein Design Labs, Inc. (PDL) recently announced an agreement for Millennium to have rights to obtain commercial licenses for multiple humanized antibodies under PDL's antibody humanization patents. The terms of this agreement call for PDL to receive an undisclosed up-front signing fee and royalties on net sales of any resulting antibody products. Access to PDL's technology supports Millennium's advancement of antibody preclinical compounds into later stage clinical development.

There is a five-year option period during which Millennium can acquire commercial product licenses for up to three humanized antibodies from PDL. The term during which Millennium can acquire commercial licenses from PDL can be extended for an additional two-year period for an option extension fee. Millennium will be responsible for product development, manufacturing and marketing of any resulting antibody products. Specific financial terms of the agreement were not disclosed. Millennium is the fifth company to sign a patent rights agreement with PDL covering multiple humanized antibodies.

"We are pleased that a leading biopharmaceutical company, like Millennium, is among the growing number of companies to acknowledge PDL's patent position in the field of humanized antibodies," said Robert Kirkman, MD, PDL's vice president, business development and corporate communications. "Millennium's impressive capabilities in discovery and development of antibody drugs will leverage PDL's humanized antibody assets so that we can participate in potential revenues from multiple therapies that have impact in the marketplace."

"Millennium's robust antibody pipeline continues to mature in downstream clinical development. This agreement with PDL will help us broaden our position as a technology innovator as we build the industry's most comprehensive toolkit for generating novel antibody therapies," said John Maraganore, senior vice president, strategic product development at Millennium. "We are delighted to be working with PDL, a company well known for its technology leadership and intellectual property in the area of humanized antibodies."

PDL's Humanized Antibody Assets

There are currently more than 40 humanized antibodies in clinical development, and PDL has licenses, patent rights agreements, or humanization agreements covering the majority of these antibodies. PDL has granted licenses under its antibody humanization patents for each of the four currently marketed humanized antibodies and receives royalties on their sales. The licensed antibodies, which had combined sales of more than $700 million in 2000, are: Synagis (palivizumab) from MedImmune, Inc., Herceptin (trastuzumab) from Genentech, Inc., Mylotarg (gemtuzumab ozogamicin for injection) from American Home Products Corporation, and Zenapax (daclizumab), which was created by PDL and is licensed to Hoffmann-La Roche Inc.

Millennium's Therapeutic Antibody Pipeline

Millennium is a leader in the discovery and development of therapeutic antibodies. The Company is awaiting final review from the U.S. Food and Drug Administration of the CAMPATH (alemtuzumab) investigational humanized monoclonal antibody for treatment of patients with chronic lymphocytic leukemia who have been treated with alkylating agents and have failed fludarabine therapy. Millennium's pipeline also includes several other antibodies in clinical development. In collaboration with Genentech, Inc., Millennium is conducting Phase II clinical trials with LDP-02 for Crohn's disease and ulcerative colitis. LDP-01 is in Phase I/II clinical trials for stroke.

Protein Design Labs, Inc., is a leader in the development of humanized antibodies to prevent or treat various disease conditions. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents in the U.S., Europe and Japan for its antibody humanization technology.

Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Mass., Millennium currently employs more than 1,200 people.

Source: Millennium Pharmaceuticals, Inc.