Millennium Pharmaceuticals, Inc. and Ortho Biotech Inc. have entered into a two-year agreement to jointly promote Velcade in the US. Velcade is the leading cancer therapeutic used to treat patients with relapsed multiple myeloma.
"With this expanded educational effort behind Velcade, we believe clinicians will be reached more frequently and more patients will have access to this important drug," said Christophe Bianchi, M.D., executive vice president, commercial operations, Millennium. "We have seen that physician education is a key driver of growth for Velcade, as evidenced by the impact of our recently expanded field force. This collaboration, with the well-established Ortho biotech oncology group, will help us to realize the full potential of the product."
Under the terms of the agreement, Ortho biotech will join Millennium in the first quarter of 2007 to promote Velcade to US based physicians who treat multiple myeloma patients who have received at least one prior therapy. The Ortho biotech sales force will dedicate a pre-specified amount of effort selling Velcade. Millennium will pay a percentage of the Velcade related costs for the Ortho biotech sales force. Ortho biotech will be entitled to receive a commission on the incremental sales that exceed pre-specified targets. Millennium will continue to be responsible for commercialization, manufacturing and distribution of Velcade in the US. The current agreement between Millennium and Ortho biotech for the promotion of Velcade outside the US remains unchanged.
Velcade is a first-in-class, market-leading product that provides an unmatched median survival of 29.8 months to relapsed multiple myeloma patients. Millennium was recently granted priority review with a PDUFA date of December 9, 2006 by the FDA for its supplementary new drug application covering Velcade for relapsed mantle cell lymphoma, an aggressive form of NHL for which there is no current standard of treatment. phase III trials are ongoing in newly diagnosed multiple myeloma patients and relapsed follicular and marginal zone lymphoma patients. More than 300 trials are ongoing or planned to explore the potential of Velcade in other cancers.
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 US; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. will co-promote Velcade in the US Velcade is approved in more than 75 countries worldwide. Velcade also is approved in the European Union as a treatment at first relapse.
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 tumour 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 per cent), diarrhoea (57 per cent), nausea (57 per cent), constipation (42 per cent), peripheral neuropathy (36 per cent), vomiting (35 per cent), pyrexia (35 per cent), thrombocytopenia (35 per cent), psychiatric disorders (35 per cent), anorexia and appetite decreased (34 per cent), parasthesia (27 per cent), dysesthesia (27 per cent), anaemia and headache (26 per cent), and cough (21 per cent). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4 per cent), neutropenia (2 percent), and hypercalcemia (2 per cent). A total of 144 patients on Velcade (44 per cent) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6 per cent), diarrhoea (5 per cent), dyspnoea and pneumonia (4 per cent), and vomiting (3 per cent).