Evidence Base for VELCADE Builds as new Data is Presented at 53rd American Society of Hematology Annual Meeting

BEERSE, Belgium, December 9, 2011 -

Landmark VELCADE^®  (bortezomib) five-year follow-up data in previously untreated multiple myeloma to be featured in oral presentation

Janssen-Cilag International NV announced today that 9 abstracts, involving both the experimental molecule siltuximab and the established therapy VELCADE, have been accepted for presentation at this year’s American Society of Hematology (ASH) annual meeting, to be held December 10-13, 2011, in San Diego, USA.

VELCADE is set to enjoy a particularly high profile with the five-year follow-up overall survival results from the pivotal, randomised VISTA trial in previously untreated multiple myeloma (MM). Additionally, data on VELCADE-based combinations in the consolidation and maintenance settings in MM, as well as relapsed/refractory MM, subcutaneous administration and use in the treatment of non-Hodgkin’s lymphoma will be presented. In total, VELCADE will be highlighted in 7 abstracts, including 2 oral presentations.

“We are very excited to present new evidence demonstrating the benefit offered by VELCADE therapy across various patient groups, modes of administration, and tumor types,” commented William N. Hait, M.D., Ph.D., Global Head, Oncology R&D, Janssen Research & Development.  “The new data to be presented at ASH highlight our continued commitment to VELCADE and our ongoing research programme into its further application.” 

Notable VELCADE presentations at ASH will include:

Continued Overall Survival Benefit After 5 years’ Follow-up with Bortezomib-Melphalan-Prednisone (VMP) versus Melphalan-Prednisone (MP) in Patients with Previously Untreated Multiple Myeloma, and no Increased Risk of Second Primary Malignancies: Final Results of the Phase 3 VISTA Trial

Jesús F. San Miguel et al.

Bortezomib-melphalan-prednisone resulted in a substantial long-term overall survival (OS) benefit vs melphalan-prednisone (median OS of nearly 5 years [56.4 months] vs. 3.6 years [43.1 months], a 13.3 month increase in median OS). This was seen across multiple patient subgroups and was regardless of extensive subsequent therapy.

Identification of Patient Subgroups Demonstrating Longer Progression-Free Survival (PFS) Benefit with Bortezomib-Rituximab Versus Rituximab in Patients with Relapsed or Refractory Follicular Lymphoma (FL): Biomarker Analyses of the Phase 3 LYM3001 Study

Bertrand Coiffier et al.

Analyses of the phase 3 LYM3001 trial identified biomarker combinations present in a third of patients offering a significant progression free survival benefit with bortezomib-rituximab vs rituximab (median 14.2 vs 8.4 months, p=0.0003) and an indication of longer overall survival (HR 0.44, p=0.1291).

Second Malignancies Among Elderly Multiple Myeloma Patients Exposed to Bortezomib and Other Treatments: An Analysis of the US Seer-Medicare Linked Database

Dina Gifkins et al.

Based on more than 9,000 elderly MM patients, there was a lower prevalence of second malignancies among patients exposed to bortezomib (1.4%) compared to those with no documented exposure to bortezomib (4.5%).

About VELCADE® (bortezomib)

VELCADE^® (bortezomib) is a medicine used to treat the blood-based cancer known as multiple myeloma. It contains an active substance called bortezomib and is the first in a new class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die.

It is licensed in the EU for use in combination with melphalan and prednisone in previously untreated patients with multiple myeloma (i.e. the front line setting) who are ineligible for high-dose chemotherapy and bone marrow transplant and as monotherapy for the treatment of progressive multiple myeloma in patients who have received at least 1 prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

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.¹

VELCADE is the market leader in treating relapsed multiple myeloma with over 300,000 patients treated worldwide. VELCADE is co-developed by Millennium Pharmaceuticals and Janssen Pharmaceutical Companies of Johnson & Johnson. Millennium is responsible for commercialization of VELCADE in the U.S., Janssen Pharmaceutical Companies of Johnson & Johnson are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-emea.com

Notes to Editors:

• 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, with more than 18,000 people in the European Union dying each year from the disease. ^[3,4]
• P-value is a statistical term. It is the measure of probability that a difference between groups during an experiment happened by chance.  For example, a p-value of .01 (p = .01) means there is a 1 in 100 chance the result occurred by chance. The lower the p-value, the more likely it is that the difference between groups was caused by treatment.^[5]

References

1. www.multiplemyeloma.org (accessed November 2011)

2. GLOBOCAN 2002, www-dep.iarc.fr (accessed November 2011)

3. Brenner H. Lancet 2002; 360:1131-1135

4. GLOBOCAN 2002, www-dep.iarc.fr (accessed November 2011)

5. National Cancer Institute. NCI Dictionary of Cancer Terms: P-value. www.cancer.gov/dictionary. (accessed 20 November 2007)

For more information, please contact:

Satu Kaarina Glawe
Communications & Public Affairs EMEA
0049-172-294-6264

Kelly Blaney
Reynolds-MacKenzie
0044-(0)-20-3427-5812

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