Millennium Pharmaceuticals, Inc. said that it will receive a $40 million payment from a Johnson and Johnson unit for achieving certain sales targets for its cancer drug Velcade.

Velcade is currently promoted in the US by Millennium and Ortho Biotech Products, L.P, a J&J unit. In June 2003, Millennium entered into an agreement with Ortho Biotech Products, L.P. to collaborate on the commercialisation and continued clinical development of Velcade. Under the terms of the agreement, Ortho Biotech and its affiliate, Janssen-Cilag, commercialise Velcade outside of the US and Millennium receives royalties on sales outside of the US. In addition, Millennium may receive payments for achieving clinical, development and regulatory approvals and sales milestones outside of the US.

"Velcade is the market leader in the relapsed multiple myeloma setting with a pending approval in the front-line setting," said Christophe Bianchi, M.D., executive vice president, commercial, Millennium. "This milestone payment represents the continued strong growth of the product worldwide."

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 55,000 individuals have multiple myeloma and approximately 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

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. Velcade is approved in 85 countries worldwide. More than 85,000 patients have been treated with Velcade globally.

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 SAEs included pneumonia (7 per cent ), pyrexia (6 per cent ), diarrhoea (5 per cent ), vomiting (4 per cent ), and nausea, dehydration, dyspnea and thrombocytopenia (each 3 per cent ). Adverse events thought by the investigator to be drug-related and leading to discontinuation occurred in 22 per cent of patients. The reasons for discontinuation included peripheral neuropathy (8 per cent ), asthenic conditions (3 per cent ) and thrombocytopenia and diarrhoea (each 2 per cent). In total, 2 per cent of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the phase III, Velcade plus DOXIL study.

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.