TEMPLATE PRESS RELEASE

VELCADE® (bortezomib) Approved For Previously Untreated Multiple Myeloma
- VELCADE approved across all disease stages for broad spectrum of patients -

On June 2008, Janssen-Cilag / Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, announced the FDA approval of VELCADE for the treatment of previously untreated patients with multiple myeloma (MM), a fatal blood cancer who are not eligible for transplant.  In more than 87 countries worldwide, VELCADE has already been approved for the treatment of relapsed and / or refractory MM in patients who have received at least one prior therapy. 

VELCADE has quickly become one of the most valuable therapies for patients with multiple myeloma for its significant contribution to both increasing survival and improving quality of life.  VELCADE has helped increase the five-year survival rate for multiple myeloma and we hope that rate will continue to rise with patients receiving access to treatment at the earliest stage of disease.

The approval is based on the phase III VISTA trial, which demonstrated highly significant, superiority across all efficacy endpoints, compared to the standard of care.  In particular, complete response (CR) rates were similar to those achieved in the transplant setting and led to improved overall survival. 

VELCADE® as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone (VISTA) Results [from ASH 2007 data presentation]
VISTA is a randomised, international, open-label phase III study which compared VELCADE plus melphalan and prednisone (VMP) with melphalan and prednisone (MP) alone as a treatment for 682 previously untreated patients who were ineligible for stem cell transplantation. The efficacy and overall safety and tolerability of this regimen compared with MP alone was assessed:

1. VMP patients achieved more and greater quality responses (30 percent CR with 40 percent partial response (PR)) compared to MP patients (4 percent CR with 31 percent PR)
2. Patients on the VMP combination achieved a greater overall survival rate at 24 months (85 percent) compared to MP alone (72 percent)
3. At two years, twice as many VMP patients (40 percent) had not progressed versus MP patients (20 percent), translating into a highly statistically significant increase in median time to progression (p <.0001)
4. At two years, 64 percent of VMP patients still had not required second-line treatment compared to MP (42 percent)
5. VMP demonstrates a highly significant duration of response (median 20 months vs 13 months with MP), which was even greater in those patients who achieved a CR (median 24.0 months vs 12.8 months with MP)

?VELCADE continues to play a vital role in effectively managing multiple myeloma at all stages of disease across multiple patient populations. We continue to explore the full potential and unique benefits of VELCADE in multiple myeloma and other disease areas to provide patients with additional treatment options.?

About VELCADE®
VELCADE® (Bortezomib), is a novel agent and first in class. It is a proteasome inhibitor and indicated in Multiple myeloma disease as a first line agent and in mantle cell lymphoma (Non Hodgkin Lymphoma) as a second line treatment.
VELCADE® is approved for the treatment of MM in more than 87 countries worldwide. VELCADE was approved after first relapse and now is indicated for use in patients with previously untreated MM (who are unsuitable for bone marrow transplantation / high dose chemotherapy). Clinical trials are now underway to investigate the potential of VELCADE in additional settings and in combination with other anti-cancer drugs to enhance treatment effects or reverse resistance .

VELCADE has a predictable safety profile and a favourable benefit?risk ratio.
It is the market leader in treating relapsed multiple myeloma with over 85,000 patients treated worldwide.