ZYTIGA® Approved in the EU for Use in the Treatment of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy

  ZYTIGA® Approved in the EU for Use in the Treatment of Metastatic
  Castration-Resistant Prostate Cancer Before Chemotherapy

Business Wire

BEERSE, Belgium -- January 11, 2013

Janssen-Cilag International NV (Janssen) announced today that the European
Commission (EC) has approved an extension to the license of the oral,
once-daily medication ZYTIGA^® (abiraterone acetate). The approved broader
indication for ZYTIGA now includes its use, in combination with prednisone or
prednisolone, for the treatment of metastatic castration-resistant prostate
cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after
failure of androgen deprivation therapy in whom chemotherapy is not yet
clinically indicated.^1

Until now, ZYTIGA with prednisone and prednisolone has only been approved to
treat men with mCRPC whose disease has progressed on or after a
docetaxel-based chemotherapy regimen. This latest approval means that eligible
men will potentially be able to benefit from treatment with ZYTIGA^® earlier
in the treatment pathway.

The EC’s decision follows recommendations from the Committee for Medical
Products for Human Use (CHMP) of the European Medicines Agency^2 that were
based on data from the Phase III COU-AA-302 study.^3 This was the first
randomised study to demonstrate a radiographic progression-free survival
(rPFS) benefit and a strong trend in overall survival (OS) in this patient
population.

Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa,
commented, “This decision by the European Commission is hugely welcomed news.
It marks another important step forward in the treatment of men with advanced
castration-resistant prostate cancer. Treating men with ZYTIGA before they
undergo chemotherapy has been shown to improve outcomes in many patients, both
in terms of extending survival and in bettering quality of life. The fact that
ZYTIGA’s licence has now been extended to include this indication will help
fill a critical medical need and, we hope, serve to significantly improve the
lives of many men across Europe suffering from this disease.”

                                    -ENDS-

NOTES TO EDITORS

About the COU-AA-302 study^3

Study COU-AA-302 is a Phase III, international, randomised, double-blind,
placebo controlled study which evaluated ZYTIGA^® plus prednisone/prednisolone
compared to placebo plus prednisone/prednisolone in 1,088 asymptomatic or
mildly symptomatic men with mCRPC who had not received prior chemotherapy. The
co-primary endpoints of the study were radiographic progression-free survival
(rPFS) and overall survival (OS).

The results were published in The New England Journal of Medicine in December
2012.^4 The data demonstrated a statistically significant improvement in rPFS
in the abiraterone acetate plus prednisone/prednisolone arm (ZYTIGA^® arm) of
the study compared to the placebo plus prednisone/prednisolone (control) arm.
Additionally, treatment with ZYTIGA^® plus prednisone/prednisolone resulted in
a longer OS than with placebo (median OS in the ZYTIGA^® arm was not reached
because progression events occurred more slowly in the ZYTIGA^® arm compared
to the control arm. At the time of the interim analysis, statistical
significance for OS was not reached.

In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously
recommended unblinding of this study after the pre-specified analysis. Based
on the results, the IDMC also recommended that patients in the control arm be
offered treatment with ZYTIGA^®.

Secondary Endpoints^3

Treatment with ZYTIGA^® plus prednisone also demonstrated significant
improvements in secondary study endpoints compared to the control arm.
Specifically, longer time until:

  *Opiate use for cancer pain
  *Initiation of cytotoxic chemotherapy for prostate cancer
  *Deterioration in performance status (Eastern Cooperative Oncology Group
    (ECOG*) performance score of one point or more)
  *PSA progression, based on The Prostate Cancer Clinical Trials Working
    Group (PCWG2) criteria

* The ECOG performance score is a standard measure used to assess functional
status of a patient and is often used to determine prognosis and appropriate
treatment.

Safety Findings in the COU-AA-302 study^3

Patients in the ZYTIGA^® arm of the study experienced more grade 3 and grade 4
adverse events than those in the control arm, including cardiac disorders (6%
vs. 3%) and hypertension (4% vs. 3%), as well as increases in alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) (5.4% vs. 0.8% and
3.0% vs. 0.9%, respectively). Fatigue was the most common adverse event
observed in the study.

About metastatic castration-resistant prostate cancer

Metastatic castration-resistant prostate cancer occurs when cancer has
metastasised (spread) beyond the prostate to other parts of the body and the
disease progresses despite serum testosterone below castrate levels.^5

The prostate is a gland in men that produces part of the seminal fluid and is
located around the urethra (under the bladder). In some cases, cancer of the
prostate can grow slowly. However, depending on factors including
characteristics specific to the patient and the tumour, prostate cancer also
can grow very quickly and spread widely.^6

In 2008, an estimated 370,000 new cases of prostate cancer were diagnosed in
Europe, and nearly 90,000 men died from the disease.^7

About ZYTIGA^®8

Since its approval in 2011, ZYTIGA^® has been approved in more than 60
countries worldwide, many thousands of men have received treatment with it,
and it is quickly becoming one of the cornerstones of our oncology offerings.

ZYTIGA^® is the only approved therapy that inhibits production of androgen,
which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex
present at three sources: the testes, adrenals and the tumour itself.

The U.S. Food and Drug Administration also recently approved an expanded
indication.^9

Side effects:^8

                         IMPORTANT SAFETY INFORMATION

For a full list of side effects and for further information on dosage and
administration, contraindications and other precautions when using ZYTIGA,
please refer to ZYTIGA’s summary of product characteristics, which will be
available at http://www.ema.europa.eu/ema/

Most common: urinary tract infection, hypokalaemia, hypertension, peripheral
oedema

Common: hypertriglyceridaemia, cardiac failure (including congestive heart
failure, left ventricular dysfunction and decreased ejection fraction), angina
pectoris, arrhythmia, atrial fibrillation, tachycardia, increased alanine
aminotransferase, fractures (includes all fractures with the exception of
pathological fracture), dyspepsia, haematuria and rash.

Uncommon: adrenal insufficiency.

About Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our time,
including oncology, immunology, neuroscience, infectious disease, and
cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services
and healthcare solutions to help people throughout the world.

More information can be found at  www.janssen-emea.com

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

References

^1 http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h
[last accessed January 2013]

^2
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/WC500134841.pdf
[last accessed January 2013]

^3 Ryan C.J et al. Interim analysis (IA) results of COU-AA-302, a randomized,
phase III study of abiraterone acetate (AA) in chemotherapy-naive patients
(pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin
Oncol 30, 2012 (suppl; abstr LBA4518)

^4 Ryan C.J et al. Abiraterone in Metastatic Prostate Cancer without Previous
Chemotherapy. N Engl J Med 2012. DOI: 10.1056/NEJMoa1209096

^5 Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer.
Curr Oncol. 2010 September; 17(Supplement 2): S72–S79.

^6 Mayo Clinic. “Prostate Cancer.”
http://www.mayoclinic.com/health/prostate-cancer/DS00043. [last accessed
January 2013]

^7 http://globocan.iarc.fr/factsheet.asp [last accessed January 2013]

^8 ZYTIGA^® summary of product characteristics to be available on the EMA
website: http://www.ema.europa.eu/ema/

^9
http://www.prnewswire.com/news-releases/us-fda-approves-expanded-zytiga-indication-for-treatment-of-metastatic-castration-resistant-prostate-cancer-182852141.html
[last accessed January 2013]

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Contact:

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or
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