Abiraterone Acetate Significantly Improved Overall Survival for Patients With Metastatic Advanced Prostate Cancer

Note: Data in This Release Correspond to ESMO Abstract LBA5

BEERSE, Belgium, October 11, 2010 - Results from a pre-specified interim analysis of a randomised,
placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients
treated with the investigational agent abiraterone acetate plus low dose
prednisone/prednisolone showed a significant improvement in overall survival
compared to patients treated with prednisone/prednisolone plus placebo. This
study included 1,195 patients with metastatic advanced prostate cancer (also
referred to as castration-resistant prostate cancer, or CRPC) previously
treated with one or two chemotherapy regimens, at least one of which
contained docetaxel.

The results of this randomised, placebo-controlled study were shared
during a late-breaking presentation at the Presidential Symposium today at
the 35th Annual European Society for Medical Oncology (ESMO) Congress.

Treatment with abiraterone acetate resulted in a 35 percent reduction in
the risk of death (HR=0.65; 95 percent CI: 0.54, 0.77; p<0.0001) and a 36
percent increase in median survival (14.8 months vs. 10.9 months) compared
with placebo.

Patients who received abiraterone acetate and low dose
prednisone/prednisolone also showed significant improvements in secondary
study endpoints when compared to the prednisone/prednisolone plus placebo
group: time to PSA progression (TTPP) [median 10.2 months for abiraterone
acetate vs. 6.6 months for placebo, HR=0.58 (95 percent CI: 0.46, 0.73);
p<0.0001] and an increase in radiographic progression free survival (rPFS)
[median 5.6 months for abiraterone acetate vs. 3.6 months for placebo,
HR=0.67 (95 percent CI: 0.58, 0.78); p<0.0001]. Total PSA response, defined
as greater than or equal to a 50 percent decrease from baseline, was achieved
in 38 percent of patients treated with abiraterone acetate vs. 10 percent in
the prednisone/prednisolone plus placebo group [p<0.0001].

Patients in the abiraterone acetate group experienced more
mineralocorticoid-related adverse events than those in the
prednisone/prednisolone plus placebo group. The most frequent adverse events
were fluid retention (30.5 percent vs. 22.3 percent) and hypokalaemia (17.1
percent vs. 8.4 percent). Grade 3/4 hypokalaemia and hypertension were more
frequent in the abiraterone acetate arm than in the placebo arm (3.8 percent
vs. 0.8 percent and 1.3 percent vs. 0.3 percent, respectively). Liver
function test abnormalities were observed in 10.4 percent of abiraterone
acetate treated patients compared to 8.1 percent in the
prednisone/prednisolone plus placebo group. Cardiac disorders were observed
in 12.5 percent of abiraterone acetate patients vs. 9.4 percent of patients
who received placebo. Mechanism-based adverse events were amenable to medical
management and distinct from adverse events commonly associated with
cytotoxic chemotherapy.

"Abiraterone has the potential to meet a significant unmet need so this
news will be incredibly important to prostate cancer patients and their
families," said Johann S. de Bono, MD, FRCP, MSc, PhD, The Institute of
Cancer Research, The Royal Marsden NHS Foundation Trust, one of the lead
COU-AA-301 investigators. "We are very pleased with the definitive results of
this rigorous study, which show that abiraterone acetate may extend survival
for men with metastatic advanced prostate cancer that progressed after
treatment with docetaxel."

The Company plans to file marketing applications for abiraterone acetate
with regulatory authorities in the US and Europe by the end of the year.
Applications in the rest of the world will follow, according to local
regulatory requirements. If approved, abiraterone acetate will be
commercialised and distributed by Centocor Ortho Biotech, Inc. in the United
States and by Janssen Pharmaceutical Companies in all other countries around
the world.

"Globally, prostate cancer, the fifth most common cancer overall, is a
significant public health problem," said Howard I. Scher MD, Memorial
Sloan-Kettering Cancer Center, one of the lead COU-AA-301 investigators.
"These results are important because men with progressive metastatic,
castration-resistant prostate cancer often have a poor prognosis and
currently have few treatment options."

A program that provides early access to abiraterone acetate for eligible
patients is expected to be opened in the United States in October and will be
opened in sites outside the United States in the following months, with the
timing of the program contingent on local health authority and ethics
committee approvals.

"The results of this abiraterone acetate Phase 3 study in patients with
metastatic advanced prostate cancer bring us closer to achieving our goal of
developing extraordinary preventive, diagnostic and therapeutic solutions
based on our tumour microenvironment strategy," said William N. Hait, MD,
PhD, Global Therapeutic Head, Oncology, Ortho Biotech Oncology Research &
Development. "We believe that abiraterone acetate is an important medical
advance, and we look forward to further developing oncology therapeutic
options that may impact patients' lives."

Ortho Biotech Oncology Research & Development, a unit of Cougar
Biotechnology, Inc., previously announced that the Independent Data
Monitoring Committee recommended unblinding this Phase 3 study after a
pre-specified interim analysis demonstrated a statistically significant
improvement in median overall survival and an acceptable safety profile. The
IDMC also recommended that patients in the prednisone/prednisolone plus
placebo group be offered treatment with abiraterone acetate.

Study Design

This randomised, double-blind placebo-controlled Phase 3 study was
conducted in 147 centers in 13 countries. Patients with metastatic advanced
prostate cancer previously treated with docetaxel (N=1,195) were randomly
assigned 2:1 to receive abiraterone acetate (1000 mg once daily) plus
prednisone/prednisolone (5 mg twice daily) (N = 797), or placebo plus
prednisone/prednisolone (N = 398). The primary endpoint was overall survival.

About Abiraterone Acetate

Abiraterone acetate is a novel, targeted, investigational, oral androgen
biosynthesis inhibitor being developed for the treatment of metastatic
advanced prostate cancer that has progressed after developing resistance to
conventional hormonal therapies. This is also known as castration-resistant
prostate cancer (CRPC).

About Prostate Cancer

Prostate cancer occurs when cancer cells form in the tissues of the
prostate. The prostate is a gland located around the urethra (under the
bladder) in men that produces part of the seminal fluid.[1] In some cases,
cancer of the prostate can grow slowly compared with other cancers. However,
depending on factors including characteristics specific to the patient and
the tumour, prostate cancer can also grow very quickly[2] and spread to other
places such as the lymph nodes, bones or other parts of the body. Prostate
cancer is considered to be advanced once it has spread beyond the prostate
region.1

Globally, prostate cancer is the second most frequently diagnosed cancer
in men and the fifth most common cancer overall.[3] More than 900,000 new
cases of prostate cancer were diagnosed in 2008 and more than 258,000 men
died from the disease, a 16 percent increase from 2002. 3,[4] In the United
States, an estimated 217,000 new cases of prostate cancer and 32,000 related
deaths are expected to be reported in 2010.5 Prostate cancer represents
almost one-third of all new cancer diagnoses in men (excluding basal cell
carcinoma) and is the second-leading cause of cancer-related death in men.
[5]

About the Ortho Biotech Oncology Research & Development, unit of Cougar
Biotechnology, Inc.

Ortho Biotech Oncology Research & Development, a unit of Cougar
Biotechnology, Inc. partners with affiliated units and companies in the
Janssen Pharmaceutical Companies of Johnson & Johnson such as Centocor Ortho
Biotech, Inc. and Janssen in the research and development of oncology and
supportive care treatments.

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

About Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology,
nephrology and oncology. The company was formed when Centocor, Inc. and Ortho
Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho
Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc.
harnesses innovations in large-molecule and small-molecule research to create
important new therapeutic options. Beyond its innovative medicines, Centocor
Ortho Biotech is at the forefront of developing education and public policy
initiatives to ensure patients and their families, caregivers, advocates and
healthcare professionals have access to the latest treatment information,
support services and quality care. For more information about Centocor Ortho
Biotech, visit www.centocororthobiotech.com.

(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialise, actual
results could vary materially from J&JPRD and/or Johnson & Johnson's
expectations and projections. Risks and uncertainties include general
industry conditions and competition; economic conditions, such as interest
rate and currency exchange rate fluctuations; technological advances and
patents attained by competitors; challenges inherent in new product
development, including obtaining regulatory approvals; domestic and foreign
health care reforms and governmental laws and regulations; and trends toward
health care cost containment. 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 3,
2010. 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 J&JPRD nor Johnson & Johnson undertake to update any
forward-looking statements as a result of new information or future events
or developments.)

    References

    [1] National Cancer Institute. "What You Need to Know About Prostate
        Cancer." www.cancer.gov/cancertopics/wyntk/prostate/page1
        September 10, 2010 at.
    [2] Mayo Clinic. "Prostate Cancer."
        www.mayoclinic.com/health/prostate-cancer/DS00043. September
        10, 2010 at.
    [3] GLOBOCAN 2008 (IARC). "Prostate Cancer."
        globocan.iarc.fr/factsheets/cancers/prostate.asp. Accessed
        August 1, 2010.
    [4] Parkin, D. et al. "Global Cancer Statistics 2002." CA Cancer J Clin
        (2005) 55;74-108.
    [5] Jemal A, Siegel R, Xu J, and Ward E., et al. "Cancer Statistics,
        2010". CA Cancer J Clin. 2010;60:277-300.

Media contact: Brigitte Byl, Janssen, Public Affairs and Communications, Europe, Middle East & Africa +32(0)14-60-71-72; Anna Radnavale, +44-(0)20-7013-4404, Reynolds-MacKenzie EMEA