VELCADE(R) (bortezomib) Findings Reinforce Efficacy and Survival Across Multiple Patient Populations

Beerse, Belgium (ots/PRNewswire) -

- Preliminary Phase II Re-treatment Results and two new Analyses
From Phase III VISTA Presented at ASH Annual Meeting

Janssen-Cilag today announced preliminary results from a
prospective, international, multicenter, open-label, phase II study
showing re-treatment with VELCADE(R) (bortezomib) is an effective and
well-tolerated treatment option for patients with relapsed multiple
myeloma (MM) who had previously responded to VELCADE-based treatment.
The patient response after re-treatment was similar when VELCADE was
used alone or in combination with dexamethasone. These data were
presented in San Francisco, CA at the 50th American Society of
Hematology (ASH) Annual Meeting & Exposition.

The data demonstrate how VELCADE can play a role throughout the
treatment sequence, which is especially important since relapsed MM
patients often build a resistance to therapy. After a treatment-free
interval, response to VELCADE is shown to be high and follows an
established safety profile.

The primary objective of the study was to determine the best
response to VELCADE re-treatment in patients with relapsed MM. Among
the study patients, the best response to previous VELCADE treatment
was complete response (CR) in 34 patients (27 percent) and partial
response (PR) in 94 patients (73 percent). Re-treatment with VELCADE
alone or in combination with dexamethasone resulted in 60 percent
overall response rate (ORR) including 34 percent CR by single best
urine M-protein analysis. The safety profile of VELCADE during
re-treatment was consistent with that seen in phase II and III
studies in patients with relapsed MM.(i),(ii),(iii)

In addition, results from two new follow-up analyses of the VISTA
(VELCADE as Initial Standard Therapy in Multiple Myeloma: Assessment
with Melphalan and Prednisone) Phase III clinical trial were
presented at the ASH meeting. An analysis of the three-year survival
rate (median follow up of 25.9 months) reinforces the statistically
significant survival benefit for the VELCADE arm, which had been seen
in earlier analyses. The VELCADE melphalan-prednisone (VMP) arm had a
three-year survival rate of 72 percent versus 59 percent in the
melphalan-prednisone (MP) arm. The other analysis demonstrates
VELCADE efficacy in patients with renal impairment showing a reversal
of renal impairment in a significant number of patients.

About VELCADE(R)

VELCADE is the first proteasome inhibitor to receive worldwide
regulatory approval for the treatment of multiple myeloma (MM). In
2005, VELCADE was approved in the European Union for MM after first
relapse and has now received a positive opinion from the CHMP
recommending approval for VELCADE in combination with melphalan and
prednisone for the treatment of patients with previously untreated MM
who are not eligible for high-dose chemotherapy with bone marrow
transplant.

Clinical trials are 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. 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.

VELCADE is the market leader in treating relapsed multiple
myeloma with over 100,000 patients treated worldwide. VELCADE is
being co-developed by Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD) and Millennium: The Takeda Oncology
Company. Millennium is responsible for commercialisation of 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.

The Janssen-Cilag companies have a long and successful track
record in developing and marketing treatments for a wide variety of
conditions such as cancer, HIV, pain management, multiple myeloma,
gastroenterological disorders, epilepsy, Alzheimer's disease,
schizophrenia, acute bipolar mania, behavioural psychological
symptoms of dementia, disruptive behaviour disorders and autism. More
information can be found at http://www.janssen-cilag.com.

Notes to Editors:
- ASH Abstract Numbers: 3690, 650 and 1727.
- Multiple myeloma (MM) is the second most common blood cancer,
representing approximately one percent of all cancers and two percent
of all cancer deaths(iv).
- In 2002, there were approximately 85,700 cases of MM worldwide(v).
- Only 30 percent of MM patients survive longer than five years(vi),
with more than 18,000 people in the European Union dying each year from
the disease(vii).
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(i) Richardson PG, et al. N Eng J Med 2005;352:2487-2498.
(ii) Richardson PG, et al. N Eng J Med 2003;348:2609-2617.
(iii) Jagannath S, et al. Br J Haematol 2004;127:165-172.
(iv) http://www.multiplemyeloma.org.
(v) GLOBOCAN 2002, www-dep.iarc.fr.
(vi) Brenner H. Lancet 2002; 360:1131-1135.
(vii) GLOBOCAN 2002, www-dep.iarc.fr. the high proportion of this patient
population had advanced disease and poor prognostic factors,
achieving

ots Originaltext: Janssen-Cilag
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information, please contact: Jennifer Tear, Director,
Internal Medicine & Bio Pharmaceutical Communications EMEA, Tel:
+32-14-60-26-38, Email: JTear1@its.jnj.com