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The Company submitted a supplemental New Drug Application (sNDA) to theU.S. Food and Drug Administration (FDA) in December 2007 for the use ofVELCADE to treat patients with newly diagnosed MM. The filing is based on datafrom the landmark Phase III VISTA trial. The FDA granted the sNDA priorityreview and a decision is expected by June 20, 2008. VELCADE is currently themarket leader in relapsed multiple myeloma and the only drug approved for thetreatment of relapsed mantle cell lymphoma.
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"VELCADE based therapies continue to demonstrate unprecedented completeremission rates and survival benefits for patients with newly diagnosedmultiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer,Millennium. "Data to be presented at ASCO are expected to support that deepand durable complete remissions are an important indicator for long-termpatient outcomes. The continued strength of clinical trial data, combined withthe pending FDA approval, will further solidify VELCADE as a key component ofthe standard of care for this disease."
Newly Diagnosed Multiple Myeloma
Data to be featured at ASCO include the use of VELCADE in both newlydiagnosed transplant and non-transplant MM patients. The data from a total offive studies (four Phase II and one Phase III) will highlight how VELCADEbased therapies consistently deliver high complete remission (CR) rates andsurvival benefits to patients with newly diagnosed MM. Oral presentationhighlights are scheduled to include:
Relapsed/Refractory Multiple Myeloma
Data will be presented from several studies of VELCADE based therapies forthe treatment of relapsed MM. These data are expected to support the value ofadding VELCADE in combination with emerging and established agents, includingpatients with renal insufficiency.
Non-Hodgkin's Lymphoma (NHL)
Beyond multiple myeloma, the Company continues to pursue and supporttrials in NHL, which is expected to be the next potential growth opportunityfor VELCADE. Currently, VELCADE is the only approved therapy for patients withpreviously treated mantle cell lymphoma (MCL), the most aggressive form ofNHL. ASCO-related data will be featured for VELCADE in combination withestablished agents in patients with relapsed MCL, indolent NHL andWaldenstrom's Macroglobulinemia, including:
In addition to these highlighted trials, the Company is expected to fullyaccrue patients by the first half of this year for a large,registration-enabling Phase III trial in follicular lymphoma. The trial isdesigned under a special protocol assessment (SPA) with the FDA of VELCADE andrituximab versus rituximab alone in patients with relapsed follicularlymphoma. Final data are expected in 2010. These trials support the Company'scomprehensive development program in NHL.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy andalthough the disease is predominantly a cancer of the elderly (the median ageof onset is 70 years), recent statistics indicate both increasing incidenceand younger age of onset. In the U.S., more than 50,000 individuals have MMand 20,000 new cases are diagnosed each year. Worldwide there areapproximately 74,000 new cases and over 45,000 deaths annually.
About Non-Hodgkin's Lymphoma (NHL) and Mantle Cell Lymphoma (MCL)
NHL is the most common hematological cancer, the fifth lea
