VELCADE Receives Positive Regulatory Recommendation in the European Union for Subcutaneous Administration

New route of administration provides improved safety and greater convenience for patients and healthcare professionals

Beerse, Belgium (June 26, 2012) Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of subcutaneous (under the skin) administration of VELCADE® (bortezomib). VELCADE® is indicated for the treatment of multiple myeloma, a type of blood cancer. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib. VELCADE® plays a central role in effectively managing multiple myeloma across different patient types and lines of therapy.[1,2]

The CHMP positive opinion is based on a Phase 3 study comparing subcutaneous and intravenous administration of bortezomib for relapsed myeloma patients. The results showed that subcutaneous bortezomib is as effective as intravenous (directly into a vein) bortezomib, but subcutaneous administration reduces the frequency and seriousness of side effects. In particular, subcutaneous bortezomib causes significantly less peripheral neuropathy, pain and tingling in the extremities, a common side effect of bortezomib.[1]

The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The CHMP’s positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in mid-2012.

Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented “This positive opinion is a decisive step in making subcutaneous bortezomib available to all patients who suffer from multiple myeloma. If approved, subcutaneous administration will be the administration of choice versus intravenous, combining better tolerability with maintained high efficacy.”

Subcutaneous bortezomib also offers an alternative choice for patients with poor venous accessibility or those at risk of, or with pre-existing, peripheral neuropathy, for whom bortezomib IV may previously not have been an option.

Subcutaneous bortezomib was approved in the USA by the Food and Drug Administration (FDA) for the treatment of multiple myeloma and relapsed mantle cell lymphoma in January 2012, and by Health Canada for the treatment of multiple myeloma in March 2012.


About the MMY-3021 Phase 3 study1
The CHMP positive opinion is based on the results of an open-label, randomized, phase 3 non-inferiority study conducted in 222 patients with relapsed multiple myeloma randomly assigned to receive subcutaneous or intravenous bortezomib. The study found that patients receiving bortezomib subcutaneously achieved a four-cycle ORR of 42 per cent and CR rate of seven per cent, while patients receiving bortezomib intravenously achieved an ORR of 42 per cent and a CR rate of eight per cent. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, seven per cent of patients experienced PN of grade three or higher, compared with 16 per cent in the intravenous arm. In the subcutaneous arm, 38 per cent of patients experienced PN of all grades, compared with 53 per cent of patients in the intravenous arm. Bortezomib subcutaneous administration was also shown to reduce discontinuation and dose reduction rates compared to intravenous.


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.[5]

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 multiple myeloma (MM)
Multiple Myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excess proliferation of abnormal plasma cells.[3]  MM is the second most frequent form of malignant bone marrow diseases. It is a relatively rare form of cancer that accounts for roughly one percent of all cancers and roughly two percent of all deaths from cancer. In Europe, around 60,000 people are living with the disease and there are 21,420 new cases and 15,000 deaths every year.[4]


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

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections Janssen and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

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References

[1]Moreau MMY3021 Mateos Commentary Lancet Oncology, Published online April 19, 2011. Available at: www.thelancet.com/oncology
[2]VELCADE EPAR http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000539/human_med_001130.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 [Last accessed March 2012].
[3]http://www.myeloma-euronet.org/en/multiple-myeloma/what-is.php [Last accessed March 2012].
[4]http://www.myeloma-euronet.org/en/multiple-myeloma/faq.php [Last accessed March 2012].
[5]Adams J, Kauffman M. Development of the proteasome inhibitor VELCADE (bortezomib). Informa Healthcare 2004, 22(2); 304-311 http://informahealthcare.com/doi/abs/10.1081/CNV-120030218 [Last accessed March 2012].

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

MEDIA CONTACT:
Satu Glawe, Janssen
Communications & Public Affairs EMEA
+49 172 294 6264

INVESTOR RELATIONS:
Stan Panasewicz
+1 732-524-2524
Louise Mehrotra
+1 732-524-6491
 

Posted: June 2012


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