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Landmark VISTA Trial Shows Significant Long-Term Overall Survival Benefit of VELCADE (Bortezomib) in Patients With Previously Untreated Multiple Myeloma.

BEERSE, Belgium, December 12, 2011 /PRNewswire/ --

[c]ABenefit of bortezomib, in combination with melphalan and prednisone (VMP), seen across multiple patient subgroups regardless of subsequent extensive therapy

Janssen-Cilag International NV announced today that treatment with VELCADE(bortezomib), in combination with melphalan and prednisone (VMP), delivered a significant long-term overall survival (OS) benefit of 13.3 months (HR 0.695, p=0.0004), compared to treatment with melphalan-prednisone (MP), in patients with previously untreated multiple myeloma (MM), a fatal blood cancer.[sup.[] [sup.1]] The data, the result of the updated OS analysis of the landmark VISTA trial after 5 years of follow-up, are being presented today at the 53rd American Society for Hematology (ASH) annual meeting in San Diego.

In patients who received the bortezomib regimen the long-term OS benefit was observed across multiple patient subgroups, including those aged ≥ 75 years (median 50.7 vs 32.9 months, HR 0.71), regardless of extensive subsequent therapy.[sup.[] [sup.1]] In addition, the study concluded that there was no increased risk of secondary primary malignancies identified with VPM versus expected background rates, an important issue for MM patients receiving long-term therapy.[sup.[] [sup.1]]

"This is an important and clinically significant trial with implications for the way we manage patients," said Professor Jesus F. San Miguel, head of the department of haematology of the University Hospital of Salamanca and principal investigator of the VISTA trial. "The results demonstrate that treatment with VELCADE can help patients with previously untreated multiple myeloma to live significantly longer, which is very exciting."

This long term, five-year follow-up analysis, reported median overall survival of nearly 5 years (56.4 months) for patients randomised to VMP compared to 3.6 years (43.1 months) [HR 0.695, p=0.0004] for patients randomised to MP, reflecting a 13.3 month increase in median overall survival and a 31% reduced risk of death with VMP.[sup.[] [sup.1]] The median OS of 56.4 month achieved with VMP is comparable to the median OS achieved previously only with high dose chemotherapy and autologous stem cell transplant (50-55 month).[sup.[] [sup.2,3,4]] Time to next treatment (median 27.0 vs 19.2 months; HR 0.557, p<0.0001) and treatment-free interval (median 16.6 vs 8.3 months, HR 0.573, p<0.0001) were also superior with VMP vs MP.[sup.[] [sup.1]]

"This is fantastic news for patients affected by this fatal blood cancer," commented Anita Waldmann, president of Myeloma Patients Europe. "Patients' hopes for an extended life can now move closer towards reality."

Bortezomib has a predictable safety profile and a favourable benefit-risk ratio. The most common side effects reported with bortezomib include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.[sup.[] [sup.1]]

"VELCADE has been rapidly established as the most significant treatment to effectively manage multiple myeloma across all patient populations," said William N. Hait, M.D., Ph.D., Global Head, Oncology R&D, Janssen Research & Development. "We are delighted to be able to communicate these new findings which will further enhance the lives of patients who suffer with multiple myeloma."

About the VISTA trial

The VISTA trial is the largest Phase III registration study to report long-term OS in previously untreated multiple myeloma patients. This multicenter, international 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM who were not eligible for stem cell transplantation. The safety profile of bortezomib in combination with MP was consistent with the known safety profiles of both bortezomib and MP. This study was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development (J&JPRD).

About VELCADE[sup.] (bortezomib)

VELCADE[sup.] (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.

VELCADEhas a predictable safety profile and a favourable benefit-risk ratio. The most common side effects reported with VELCADEinclude fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.[sup.[] [sup.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 http://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.[sup.[] [sup.7]]

* In 2002, there were approximately 85,700 cases of MM worldwide.[sup.[] [sup.8]]

* 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.[sup.[] [sup.8,9]]

* 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 0.01 (p =0.01) 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.[sup.[] [sup.10]]

* Overall survival rate is the percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Median overall survival is the average overall survival rate.[sup.[] [sup.10]]

References

1.) 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. Presented at the 52nd American Society for Hematology (ASH) Annual Meeting, 12.12.11.

2.) Blade, J.et al. Transplantation for multiple myeloma: who, when, how often? Blood 2003;102(10):3469-3470.

3.) Child, A.J. et al. High-Dose Chemotherapy with Hematopoietic Stem-Cell Rescue for Multiple Myeloma. N Engl J Med 2003;348:1875-83.

4.) Harousseau, J.L. et al. Autologous Hematopoietic Stem-Cell Transplantation for Multiple Myeloma. N Engl J Med 2009;360:2645-54.

5.) http://www.ema.europa.eu [last accessed November 2011].

6.) Chiechanover A, Schwartz AL. The ubiquitin system: pathogenesis of human diseases and drug targeting. Biochim Biophys Acta 2004;1695(1-3):3-17.

7.) http://www.themmrf.org [last accessed November 2011].

8.) GLOBOCAN 2002, http://globocan.iarc.fr [last accessed November 2011].

9.) Brenner H. Lancet 2002; 360:1131-1135.

10.) National Cancer Institute. NCI Dictionary of Cancer Terms: P-value. http://www.cancer.gov/dictionary. [last accessed November 2011].

The original language of this press release is English. Translations into French, German, Italian and Spanish are provided by PR Newswire as a courtesy.

For more information, please contact: Satu Kaarina Glawe Communications & Public Affairs EMEA Cell +49-172-294-6264 Kelly Blaney Reynolds-MacKenzie +44(0)20-3427-5812
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