Millennium Pharmaceuticals, Inc. said it would present new data from more than 130 abstracts of Velcade clinical studies at the 49th ASH Annual Meeting in Atlanta, Georgia, to be held from December 8-11, 2007. The data will highlight the significant efficacy of Velcade in multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL).

"Velcade based therapies have unprecedented complete remission rates and survival benefits in multiple myeloma," said Nancy Simonian, M.D., chief medical officer, Millennium. "Data to be presented at ASH from three large, randomized Phase III trials will support the expansion of our market-leading therapy into the front-line multiple myeloma setting."

Data to be featured at ASH will continue to build on the growing body of evidence that supports the use of Velcade in both newly diagnosed transplant and non-transplant patients. The data from a total of 20 phase II and phase III front-line studies will highlight the efficacy of Velcade based therapies with consistently high CR and survival benefits.

Data will be presented from 23 studies of Velcade based therapies for the treatment of relapsed MM. These data, including settings where Velcade is used for retreatment and in patients with renal impairment, support the importance of adding Velcade in combination with numerous emerging and established agents.

Velcade is the only approved therapy in previously treated mantle cell lymphoma (MCL), the most aggressive form of NHL. Data will be featured on Velcade in various subsets of NHL, including follicular and the use of biomarkers as a predictor of patient response.

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 of age), recent statistics indicate both increasing incidence and younger age of onset. In the US, 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.

NHL is the most common haematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the US The prevalence of NHL in the US 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 US 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.

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialisation of Velcade in the US, Janssen-Cilag is responsible for commercialisation in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting Velcade in the US Velcade is approved in more than 80 countries worldwide.

In the US, Velcade is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. Velcade 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. In the European Union and many other countries worldwide, Velcade is approved for patients with multiple myeloma after first relapse.

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 tumour lysis syndrome. The most commonly reported adverse events were asthenic conditions (64 per cent), nausea (55 per cent), diarrhoea (52 per cent), constipation (41 per cent), peripheral neuropathy (39 per cent), thrombocytopenia (36 per cent), appetite decrease, including reports of anorexia (36 per cent), pyrexia (34 per cent), vomiting (33 per cent) and anaemia (29 per cent). Twenty percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (5 per cent) and neutropenia (3 per cent). Fifty percent of patients reported serious adverse events. The most commonly reported serious adverse events were pneumonia (7 per cent), pyrexia (6 per cent), diarrhoea (5 per cent), vomiting (4 per cent), and nausea, dehydration, dyspnoea and thrombocytopenia (each 3 per cent).

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Massachusetts, markets Velcade, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium's research, development and commercialisation activities are focused in two therapeutic areas: oncology and inflammation.