Millennium uses its  deep understanding of mechanisms and pathways of disease together with the unique characteristics of the individual to accelerate the prevention, detection and cure of disease. The Company's goal is to redefine diseases on the molecular level so that therapeutics can be targeted to specific patient populations, thereby offering the right treatment, to the right patient. This unique  approach relies on our deep understanding of the human genome and disease biology to focus on developing therapeutic products that target the underlying elements of disease and the molecular profiles of specific patient populations.

This scientific approach  differ than conventional approaches that detect and treat symptoms and/or apparent causes of disease broadly across all patients. They do not take into account that, due to genetic variations, a disease may manifest itself slightly differently in different types of patients.

Millennium relies on its knowledge of genomics and disease biology. It uses genetic tools to define disease endpoints at the molecular rather than phenotypic (combined genetic and environmental) level to determine which groups and subgroups of patients will respond to a treatment from discovery through to development, and which patients will fail to respond. In addition, a better understanding of the human genome offers greater understanding of the mechanisms of drug toxicity, leading to the development of potentially superior drugs that minimize serious adverse reactions.

This is a personalized approachthat yields molecular-based therapeutics. Millennium seeks to increase the efficiency and reduce the risks of the drug development process by identifying novel drug targets that are linked to the fundamental mechanisms of disease and screening compounds with toxicogenomic markers, allowing for inclusion in clinical trials those patients are most likely to benefit from the treatment being tested, as well as those genetically least likely to experience serious side effects. Millennium is uniquely positioned to play a leadership role in the discovery, development and commercialization of drugs.

Marketed drug: Velcade for multiple myeloma and mantle cell lymphoma. In addition, the firm has a rich pipeline of investigational drugs, many alliances and many patents.

NEWS

4/17/07

Findings Published in Blood Highlight Millennium Leadership in Personalized Medicine and Could Strengthen the Role of VELCADE as Foundation of Therapy in Broad Range of Multiple Myeloma Patients  

Findings published in the April 15th issue of Blood show that a team of researchers led by Millennium Pharmaceuticals(MLNM) has discovered biomarkers which may lead to identifying multiple myeloma patients likely to respond to Velcade. Velcade is the U.S. market leading therapy for previously treated multiple myeloma patients with an unsurpassed median survival of 29.8 months as a single agent.
These findings add to the body of evidence that supports the role of Velcade in the treatment of a broad range of multiple myeloma patients and highlight the applicability of genomics research. This research, in combination with similar ongoing studies, may ultimately lead to improved outcomes for patients.

The identification of these biomarkers was the result of a collaborative effort by researchers from Millennium and leading multiple myeloma academic centers. These centers included Dana-Farber Cancer Institute, Boston; Myeloma Institute of Research and Therapy at the University of Arkansas for Medical Services, Little Rock; Mayo Clinic, Scottsdale; and Department of Hematology, Erasmus Medical Center, Rotterdam.

The combined team performed genomics analyses on tumor samples from multiple myeloma patients in Velcade clinical trials. These trials included the APEX Phase 3 study, which demonstrated the superiority of Velcade over standard-of-care dexamethasone in previously treated multiple myeloma patients and is one of the first and largest prospective randomized trials to include genomics analyses.

Findings from the analyses showed that patients with an increased expression of genes in the NFk-B and adhesion molecule pathways may be more sensitive to Velcade therapy. Additionally, these findings showed that the biomarkers did not predict sensitivity to dexamethasone therapy, indicating that the biomarkers may be specific to Velcade.  

"Millennium is recognized as a leader in personalized medicine, and this publication is a testament to the strength of our clinical innovation," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The genomic findings add further knowledge about Velcade efficacy in treating a broad range of multiple myeloma patients."

Millennium and its co-development partner, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) is continuing genomics research on Velcade in additional trials. Studies include a Phase 3 trial conducted by the Dutch and German co-operative groups, HOVON and GMMG, which is evaluating a Velcade based combination in patients with newly diagnosed multiple myeloma. In addition, genomics research is ongoing in a Phase 3 trial evaluating a Velcade-based combination therapy in indolent non-Hodgkin's lymphoma.

"While the published results represent an important step forward in our genomics research, the next critical step is to conduct similar analyses with Velcade in combination with other anti-cancer agents," said George Mulligan PhD, Associate Director, Translational Medicine, Millennium. "We are committed to improving outcomes for multiple myeloma patients and this work should bring us closer to determining optimal treatment strategies."

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