CAMBRIDGE, Mass., Dec. 21 MillenniumPharmaceuticals, Inc. (Nasdaq: MLNM) today announced the submission of asupplemental new drug application (sNDA) with the U.S. Food and DrugAdministration (FDA) for VELCADE in the treatment of patients with previouslyuntreated multiple myeloma (MM). The filing is based on data from the 682patient Phase III VISTA(1) trial, one of the largest, international,randomized clinical trials for patients in this treatment setting. Janssen-Cilag International NV also submitted a Marketing Authorization Application tothe European Medicines Evaluations Agency.
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The VISTA trial compared VELCADE, melphalan and prednisone (VcMP) to thestandard regimen of melphalan and prednisone (MP) alone. For the VcMPtreatment, there was a statistically significant improvement in all efficacyendpoints, including complete remission (CR) rates, time-to-diseaseprogression (TTP) and survival.
"This submission is an important step in expanding the benefits of VELCADEtherapy from patients with relapsed disease to those with previously untreatedmultiple myeloma. We will request a priority review and, if granted, we couldexpect approval by mid-2008," said Deborah Dunsire, M.D., President and ChiefExecutive Officer, Millennium.
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 of age), recent statistics indicate both increasingincidence and younger age of onset. In the U.S., more than 55,000 individualshave MM and approximately 20,000 new cases are diagnosed each year. Worldwidethere are approximately 74,000 new cases and over 45,000 deaths annually.
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. andJohnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium isresponsible for commercialization of VELCADE in the U.S., Janssen-Cilag isresponsible for commercialization in Europe and the rest of the world. JanssenPharmaceutical K.K. is responsible for commercialization in Japan. For alimited period of time, Millennium and Ortho Biotech Inc. currently co-promoteVELCADE in the U.S. VELCADE is approved in 85 countries worldwide. More than85,000 patients have been treated with VELCADE globally.
In the U.S., VELCADE is indicated for the treatment of patients withmultiple myeloma who have received at least one prior therapy. VELCADE isindicated for the treatment of patients with mantle cell lymphoma who havereceived at least one prior therapy. VELCADE is contraindicated in patientswith hypersensitivity to bortezomib, boron, or mannitol. VELCADE should beadministered under the supervision of a physician experienced in the use ofantineoplastic therapy. In the European Union and many other countriesworldwide, VELCADE is approved for patients with multiple myeloma after firstrelapse.
Risks associated with VELCADE therapy include new or worsening peripheralneuropathy, hypotension observed throughout therapy, cardiac and pulmonarydisorders, gastrointestinal adverse events, thrombocytopenia, neutropenia andtumor lysis syndrome. Women of childbearing potential should avoid becomingpregnant while being treated with VELCADE. Cases of severe sensory and motorperipheral neuropathy have been reported. The long-term outcome of peripheralneuropathy has not been studied in mantle cell lymphoma. Acute development orexacerbation of congestive heart failure, and/or new onset of decreased leftventricular ejection fraction has been reported, including reports in patientswith few or no risk factors for decreased left ventricular ejection fraction.There have been rare reports of acute diffuse infiltrative pulmonary diseaseof unknown etiology such as pneumonitis, interstitial