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FDA Grants Priority Review to Velcade(R) (Bortezomib) for Injection for Treatment of Relapsed Mantle Cell Lymphoma Acceptance of application marks another step forward in the expansion of Velcade CAMBRIDGE, MA -- August 9, 2006 -- Millennium Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation to its supplemental new drug application (sNDA) for Velcade for the treatment of relapsed mantle cell lymphoma (MCL), an aggressive, incurable subtype of non-Hodgkin's lymphoma (NHL) for which there is no current standard of care. Priority Review is granted to a pharmaceutical compound that addresses an unmet medical need and would be a significant improvement in treatment compared to existing therapies. The FDA expedites the approval process for such a sNDA and targets a decision by six months. Acceptance of the filing indicates the FDA has determined that the sNDA is sufficiently complete to permit a substantive review. "Receiving Priority Review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma," said Deborah Dunsire, MD, President and CEO, Millennium. "Our mantle cell lymphoma application, for which we can expect a decision from the FDA by December 9, 2006, is the first step in an advanced NHL development program exploring the use of Velcade in this large and growing patient population in need of new treatment options." The sNDA submission was based on final Phase II data from the PINNACLE study, one of the largest multi-center studies in relapsed MCL to date, which showed a 33% overall response rate and an 8% complete response rate. Importantly, the median duration of response was 9.2 months, and 13.5 months in patients who achieved a complete response. These results are similar to those of four investigator initiated Phase II clinical trials where overall response rates of 30 to 40% with single-agent Velcade were established. PINNACLE Study In the prospective, single-arm study, 155 patients with relapsed or refractory MCL with a maximum of two prior therapies, received single-agent Velcade 1.3mg/m2 twice weekly for two weeks every 21 days for up to one year. Patients achieving complete response, unconfirmed complete response or partial response received a median of eight treatment cycles, and all patients in the study received a median of four cycles. Study results included: * Overall response rate of 33% * Complete response rate of 8% * Median duration of response of 9.2 months; 13.5 months in patients achieving a complete response * Median time to progression of 6.2 months * Median treatment-free interval of 13.8 months in patients achieving a complete response * Treatment was well tolerated. The most common non-hematologic adverse events were fatigue, gastrointestinal events and peripheral neuropathy. Hematologic toxicities were mild to moderate and consistent with those previously seen with Velcade. Velcade is approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy and is the market leader in relapsed multiple myeloma with over 44,000 patients treated worldwide including clinical trials. Earlier this year, Millennium and co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated a Phase III, randomized clinical trial with Velcade in combination with rituximab in patients with relapsed or refractory follicular lymphoma, a common subtype of non-Hodgkin's lymphoma. About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 10,000 with mantle cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually (2),(3). Mantle cell lymphoma is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. Because there is no generally accepted treatment approach and options often are limited, there is a need for new therapies. The average life expectancy for a patient with relapsed mantle cell lymphoma is one to two years. About Velcade Velcade is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. Risks associated with Velcade therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with Velcade. In 331 patients who were treated with Velcade in a Phase III study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). Fourteen% of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on Velcade (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%), and vomiting (3%). Velcade is the market leader in relapsed multiple myeloma with over 44,000 patients treated worldwide, including clinical trials. Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD). Millennium is responsible for commercialization of Velcade in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. Velcade is approved in more than 75 countries worldwide. Velcade also is approved in the European Union as a treatment at first relapse. SOURCE: Millennium Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version