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Millennium Pharmaceuticals, Inc. (South San Francisco, California) (MLNM) New Data Will Be Presented at ASH on VELCADE(R) (Bortezomib) for Injection-Based Therapies in Multiple Myeloma and Non-Hodgkin's Lymphoma


11/18/2008 10:42:36 AM

CAMBRIDGE, Mass., Nov. 18 /PRNewswire/ -- Millennium: The Takeda Oncology Company today announced that 120 data presentations concerning VELCADE research will be featured at the 50th American Society of Hematology (ASH) Annual Meeting in San Francisco, California, December 5-9, 2008. These presentations will include the results on overall survival and efficacy of VELCADE based therapies in patients with previously untreated multiple myeloma (MM). Additional data will be presented on VELCADE based therapies in patients with relapsed MM and non-Hodgkin's lymphoma (NHL).

(Logo: http://www.newscom.com/cgi-bin/prnh/20080827/NEW076LOGO )

"The volume of data on VELCADE, especially in the MM front-line setting demonstrates an exciting and growing interest from the hematology community," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "These data provide further evidence for the longer term benefit of VELCADE multi-drug combinations and for potential of VELCADE in combination with novel agents."

Previously Untreated Multiple Myeloma

Presentations at ASH will include data focusing on the use of VELCADE in previously untreated multiple myeloma. Abstracts are scheduled to highlight efficacy and overall survival data for VELCADE based therapies. Notable oral presentations will include seven Phase III clinical trials and seven Phase I/II studies, including:

-- Updated Follow-up and Results of Subsequent Therapy in the Phase III VISTA trial: Bortezomib Plus Melphalan-Prednisone Versus Melphalan-Prednisone in Newly Diagnosed Multiple Myeloma

-- Superior Complete Response Rate and Progression-Free survival after Autologous Transplantation with Up Front Velcade-Thalidomide-Dexamethasone Compared with Thalidomide-Dexamethasone in Newly Diagnosed Multiple Myeloma

-- VELCADE Dexamethasone (Vc/D) versus VAD as Induction Treatment Prior to Autologous Stem Cell Transplantation (ASCT) in Previously Untreated Multiple Myeloma: Updated Data from IFM 2005/01 Trial

-- Safety and Efficacy of Novel Combination Therapy with Bortezomib, Dexamethasone, Cyclophosphamide, and Lenalidomide in Newly Diagnosed Multiple Myeloma: Initial Results from the Phase I/II Multi-Center EVOLUTION Study

Relapsed Multiple Myeloma

Data will be presented from 27 studies of VELCADE based therapies for patients with relapsed MM. These data include results from VELCADE use in the retreatment setting as well as evaluation of improvement in clinical responses after treatment with other regimens.

-- Phase I/II Results of a Multicenter Trial of Perifosine (KRX-0401) + Bortezomib in Patients with Relapsed or Relapsed / Refractory Multiple Myeloma Who Were Previously Relapsed from or Refractory to Bortezomib

-- Efficacy and Safety of Re-Treatment with Bortezomib (VELCADE) in Patients with Multiple Myeloma: Results from a Prospective International Phase II Trial

-- Vorinostat Plus Bortezomib for the Treatment of Relapsed/Refractory Multiple Myeloma: Early Clinical Experience

-- Preliminary Results of CNTO 328, An Anti-Interleukin-6 Monoclonal Antibody, in Combination with Bortezomib in the Treatment of Relapsed or Refractory Multiple Myeloma

Non-Hodgkin's Lymphoma

Beyond multiple myeloma, Millennium continues to pursue and support trials of VELCADE in NHL. Currently, VELCADE is the only approved therapy for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Data will be featured for VELCADE in combination with established agents in patients with untreated MCL as well as in untreated and relapsed indolent NHL, including:

-- VcR-CVAD Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma: A Phase II Study from the Wisconsin Oncology Network

-- A Phase II Study of Combination Bortezomib (VELCADE) and Rituximab for Untreated "High Tumor Burden" Indolent Non-Hodgkin's Lymphoma

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 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 leading cause of cancer death and the second fastest growing form of cancer in the U.S. The prevalence of NHL in the U.S. is approximately 400,000 patients, including approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000 patients with follicular and marginal zone lymphoma and 10,000 with MCL. There are approximately 54,000 new cases of NHL diagnosed in the U.S. per year, and 19,000 deaths are attributed to the disease annually.

MCL is an aggressive, rapidly progressive subtype of NHL, and is not curable with standard treatment. The median life expectancy for a patient with MCL following first relapse is one to two years.

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE also is indicated for the treatment of patients with mantle cell lymphoma 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 throughout therapy, cardiac and pulmonary disorders, reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic events. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Nursing mothers are advised not to breastfeed while receiving VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. There have been reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy. Patients on oral antidiabetic medication while receiving VELCADE should check blood sugar levels frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m(2)/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of greater than or equal to Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, http://www.millennium.com.

Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com.



CONTACT: Manisha Pai, +1-617-551-7877, Manisha.Pai@mpi.com, or Karen
Gobler, +1-617-444-1392, Karen.Gobler@mpi.com, both of Millennium
Pharmaceuticals

Web site: http://www.millennium.com/

Company News On-Call: http://www.prnewswire.com/comp/114562.html/



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