Submission of Marketing Authorization Application for VELCADE® (bortezomib) in Europe

Beerse, Belgium .– Janssen-Cilag International NV, has submitted a Marketing Authorization Application to the European Medicines Evaluations Agency for the use of VELCADE® (Bortezomib) for the treatment of patients with previously untreated multiple myeloma (MM).

Millennium Pharmaceuticals, Inc., the Company’s co-development partner, also submitted a supplemental New Drug Application (sNDA) with the United States Food & Drug Administration (FDA).

The submission is based on data from the randomised, international, open-label phase III VISTA (VELCADE® as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone) study, which compared VcMP with MP as a treatment for previously untreated patients. The study was conducted at 151 centres, enrolling 682 patients in 22 countries across Europe, North and South America, and Asia.

The primary endpoint was time-to-progression, with secondary endpoints including response rates, time to and duration of response, progression-free survival, overall survival, and measures of clinical benefit such as time to next therapy. Patients on the VELCADE®-based regimen experienced a 35 percent complete response rate, defined by complete disappearance of M-protein. Furthermore, responses were durable; median duration of response for complete responders was 24 months. The median time to next therapy or treatment, a measure of clinical benefit has not been reached. This is an important benefit for patients since they have time off medication after completing treatment in contrast to other therapies. After a median of 16.3 months follow-up, a survival benefit has already been demonstrated.

This study was featured earlier this month as an oral presentation at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition in Atlanta, Georgia.

Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths.1

In 2002, there were approximately 85,700 cases of MM worldwide.2

Only 30 percent of MM patients survive longer than five years,3 with more than 18,000 people in the European Union dying each year from the disease.4

About VELCADE®

Currently VELCADE® is indicated in the EU as monotherapy for use in patients with progressive MM who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

VELCADE® is the market leader in treating relapsed multiple myeloma with over 85,000 patients treated worldwide. VELCADE® is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium Pharmaceuticals, Inc. Millennium is responsible for commercialisation of VELCADE® in the U.S. Millennium and Ortho Biotech Inc. currently co-promote VELCADE® in the U.S. Janssen-Cilag companies are responsible for commercialisation in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan.

VELCADE®has a predictable safety profile and a favourable benefit–risk ratio. The most common side effects reported with VELCADE®include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy, which is reversible in the majority of patients.
About Janssen-Cilag

The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at www.janssen-cilag.com.