VELCADE (Bortezomib) receives European marketing authorisation

04/28/04

First new cancer treatment for multiple myeloma in a decade

Brussels, Belgium, {27 April 2004} – Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has issued a positive decision for VELCADE, a new treatment for multiple myeloma, a form of blood cancer. The novel drug is indicated to treat multiple myeloma patients who have received at least two prior therapies and demonstrated disease progression on their last therapy.

VELCADE is a completely new approach to treating multiple myeloma that acts on a unique target in cells called the proteasome.

Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths. Worldwide in 2000, there were 73,943 cases of multiple myeloma and 57,370 deaths. In Europe there were approximately 19,000 cases in 2000 and just under 15,000 deaths (1). Only 30 percent of multiple myeloma patients survive longer than five years (2).

"The approval of VELCADE by the European Agency for the Evaluation of Medicinal Products (EMEA) represents a breakthrough in our continued battle against multiple myeloma" said Professor Mario Boccadoro, Professor of Hematology, Director of the Section of Hematology, University of Torino, Italy. "With its new and unique mechanism of action, VELCADE represents a new treatment option for patients".

Clinical results from a phase II study have shown that VELCADE can slow, reverse or halt progression of disease in patients who failed on two or more treatments, potentially helping patients live longer. In a study of 202 patients with relapsed and refractory multiple myeloma and who progressed after initial treatments, 35% responded to VELCADE and 10% had a complete remission. This pivotal study was the basis for an accelerated review of VELCADE by U.S. Food and Drug Administration (FDA) and approval within four months of the New Drug Application submission on 13 May 2003.

"We are delighted that marketing authorisation for VELCADE has been granted, as it is the first major advance for patients with multiple myeloma in more than a decade, and marks the company's commitment to Oncology." said Ken Watters, European Medical Director, Ortho Biotech.

"The approval of VELCADE today brings renewed hope to thousands of European multiple myeloma patients and their families" said Eric Low, Executive Director, International Myeloma Foundation (UK). "The multiple myeloma advocacy community has campaigned tirelessly over the years for cutting edge treatments such as VELCADE to be made available to patients, this is a very proud day", he continued.

The findings of a pre-specified interim analysis from an ongoing phase III trial which compared VELCADE to dexamethasone in refractory multiple myeloma patients found a statistically significant improvement in time to disease progression – the primary endpoint of the trial – in patients receiving VELCADE compared to patients receiving high-dose dexamethasone. Patients in the control arm of the trial were given the opportunity to switch to VELCADE as soon as possible based on an interim analysis that found a statistically significant improvement in TTP in patients receiving VELCADE compared to patients receiving dexamethasone.

VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. There are approximately 50 ongoing clinical trials (in Europe and the US) investigating the potential of VELCADE in all stages of multiple myeloma and other cancers.

A single licence has been granted to market VELCADE in the 15 member states of the EU, plus Norway and Iceland. In addition it will be available in the 10 accession countries.

VELCADE is being 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. Ortho Biotech Products L.P. and the Janssen-Cilag group of companies will be responsible for commercialization in the EU and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.

"With a substantial clinical programme already underway, we look forward to further developing this unique and exciting compound and possibly help patients with other types of cancers," said Ken Watters, European Medical Director, Ortho Biotech.

Source: Eurekalert & others

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