CHMP Gives a Positive Opinion for the Use of VELCADE® as Retreatment and for Frontline Induction Therapy before Stem Cell

  CHMP Gives a Positive Opinion for the Use of VELCADE® as Retreatment and for
  Frontline Induction Therapy before Stem Cell Transplantation

Label updates could lead to significantly improved outcomes for patients with
                               multiple myeloma

Business Wire

BEERSE, Belgium -- June 28, 2013

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 on two variations relating to the use of
VELCADE^®.^1 VELCADE^® is indicated for the treatment of multiple myeloma, a
type of blood cancer.

The first recommendation is for the use of VELCADE^® (bortezomib) as
retreatment in adult patients who have previously responded to treatment with
the same medicine.^1 The positive opinion re-enforces the existing data
supporting the use of VELCADE^® in this wider relapsedpatient population in
the European Union. This is now included in the label and does not require an
additional decision from the European Commission.

Concurrently, the CHMP also announced a positive opinion recommending the
approval of VELCADE^® as induction therapy in combination with dexamethasone
(VD) or dexamethasone and thalidomide (VDT). This is for adult patients with
previously untreated multiple myeloma who are eligible for high-dose
chemotherapy with haematological stem cell transplantation.^1 This will now be
^ referred for approval to the European Commission.

VELCADE^® was previously indicated for use in combination with melphalan and
prednisone for the treatment of multiple myeloma in adult patients that are
previously untreated but ineligible for high-dose chemotherapy with
haematological stem cell transplant, and alone in advanced multiple myeloma.
These label updates could mean significantly improved outcomes for many
patients with this disease.

VELCADE^® (bortezomib) as retreatment therapy^2

The submission for use of VELCADE^® in adult patients who have previously been
treated with the medicine but have since relapsed is supported by data from
the Phase II RETRIEVE (MMY2036) study. The primary objective of this study was
best confirmed response at retreatment. This study included heavily
pre-treated VELCADE^® patients, who had previously achieved a partial or
greater response, and had at least six months since their previous VELCADE^®

VELCADE^® as induction therapy prior to stem cell transplantation^3,4

The submission for license extension was based on the analysis of data from
two Phase III trials (IFM-2005-01, PETHEMA/GEM) which demonstrated that
treatment with VELCADE^®-based induction resulted in improvements in
progression-free survival (PFS), and post-induction and post-transplant
response rates.

The trials studied the use of VELCADE^®-based regimens VD and VDT, compared to
non-VELCADE^®-based regimens of vincristine plus doxorubicin and
dexamethasone, and thalidomide and dexamethasone, respectively, as induction
therapy prior to autologous stem cell transplant in adult patients with
previously-untreated multiple myeloma.


The CHMP is the committee responsible for the scientific assessment of
products seeking centralised marketing authorisation throughout the European

The positive opinion on retreatment re-enforces the existing data supporting
the use of VELCADE^® in the relapsedpatient population who have previously
responded to treatment with the same medicine. The positive opinion
recommending VELCADE^® as frontline induction therapy is now referred for
approval to the European Commission (EC) who will decide on whether to follow
its guidance and grant an extension to the current European license for
VELCADE^®. Janssen expects that a decision from the European Commission on
this will be announced in September 2013.

About VELCADE^®5,6

VELCADE^® 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.

Until now, it has been licensed in the EU for use in combination with
melphalan and prednisone in previously untreated adult patients with multiple
myeloma (i.e. the front line setting) who are ineligible for high-dose
chemotherapy with haematological stem cell transplant, and as monotherapy for
the treatment of progressive multiple myeloma in patients who have received at
least one prior therapy and who have already undergone or are unsuitable for
haematological stem cell transplant.

The European Commission recently granted marketing authorisation for the
subcutaneous (under the skin) administration of VELCADE^® (bortezomib) in the
European Union. Subcutaneous bortezomib has fewer side effects and offers
greater convenience for patients, with similar efficacy compared to
intravenous bortezomib.

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.

VELCADE^® is the market leader in the treatment of frontline non-transplant
eligible multiple myeloma with over 400,000 patients treated worldwide.
VELCADE^® is co-developed by Millennium Pharmaceuticals and Janssen
Pharmaceutical Companies. Millennium is responsible for commercialization of
VELCADE^® in the U.S., Janssen Pharmaceutical Companies 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.^7

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.^8

About Janssen

Janssen-Cilag International NV (Janssen) is one of the Janssen Pharmaceutical
Companies of Johnson & Johnson. We 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

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 of Janssen Cilag
International NV, any of the Janssen Pharmaceutical Companies 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 December 30,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at, or on request from Johnson & Johnson. None
of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments.



1. CHMP opinion:

2. Petrucci M,T et al, Br J of Haem, 2013; 160: 649-659

3. Rosiñol L et al. Blood 2012; 120: 1589-1596.

4. Harousseau J-L et al. J Clin Oncol 2010; 28:4630-4635

[Last accessed June 2013].

[Last accessed November 2012].

7. [Last
accessed June 2013].

8. [Last accessed
June 2012].

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


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