ZYTIGA®* Now Reimbursed in Québec for Use Prior to Chemotherapy in Men with Metastatic Prostate Cancer

February 6, 2014

TORONTO, Feb. 6, 2014 /CNW/ – Men with metastatic castration-resistant
prostate cancer (mCRPC) in Québec now have access to a therapy that can
be used prior to chemotherapy. Effective February 3, 2014, the province
has added ZYTIGA(®) (abiraterone acetate) to the public drug formulary for the treatment of
mCRPC in men who are asymptomatic or mildly symptomatic after failure
of androgen deprivation therapy (ADT).(1)

“ZYTIGA(® )provides men and health care professionals with a proven treatment
option after failure of androgen deprivation therapy, helping delay the
progression of metastatic prostate cancer and improving overall quality
of life. It also gives urologists like myself, the opportunity to
ensure patients will benefit from our expertise for longer and maintain
continuity of care,” says Dr. Lorne Aaron* Urologist, Charles-Lemoyne
Hospital. “I applaud the decision to add ZYTIGA(®) to the Québec public drug formulary for treatment earlier in advanced

In July 2011, ZYTIGA(® )was approved by Health Canada for the treatment of men with mCRPC who
had received prior chemotherapy containing docetaxel after failure of
ADT.(2) Health Canada approved a second indication for ZYTIGA(®) in May 2013 for the treatment of men with mCRPC who are asymptomatic or
mildly symptomatic after failure of ADT.(3)

Québec joins British Columbia as the second province to add ZYTIGA(®) to its public formulary for men with mCRPC who are asymptomatic or
mildly symptomatic after failure of ADT.

Men with advanced prostate cancer, their caregivers and health care
professionals in Québec are encouraged to learn more about the specific
eligibility criteria that are required to be met for reimbursement of
ZYTIGA(®) by accessing the published list of medications covered by the Québec
public drug formulary found on the Régie de l’assurance maladie du Québec (RAMQ) website.

About Prostate Cancer in Canada

Prostate cancer is the most common cancer to afflict men in Canada.
According to the Canadian Cancer Society, approximately 4,800 men in
Québec are diagnosed with prostate cancer annually, and approximately
860 will die of the disease.(4) Prostate cancer has a great impact on quality of life, affecting men
physically, psychologically and socially.(5) Approximately 10 to 20 per cent of prostate cancer cases will present
with metastatic disease, in which the tumour spreads beyond the
prostate.(6) Fortunately, death rates have been declining since the mid-1990s.(7)

About ZYTIGA(®)

ZYTIGA(®) selectively inhibits the enzyme complex that is required for the
production of androgens. Androgens are hormones that promote the
development and maintenance of male sex characteristics; however, in
prostate cancer androgens can work to fuel tumour growth.

ZYTIGA(® )is the first oral treatment that inhibits androgen production at all
three sources – the testes, adrenal glands and in the tumour itself. In
combined data from the Phase 3 pivotal trials, the most common adverse
reactions seen with ZYTIGA(®) are fluid in the legs, low blood potassium, urinary tract infection,
liver function test increases, indigestion, presence of blood in the
urine, high blood pressure, and bone fractures.(8)

About Janssen Inc.

At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, metabolic and chronic
diseases and women’s health. Driven by our commitment to patients, we
bring innovative products, services and solutions to people throughout
the world. Janssen Inc. is part of the Janssen Pharmaceutical
Companies. Please visit www.janssen.ca for more information.

*All trademark rights used under license.

**Dr. Lorne Aaron was not compensated for any media work. He has been a
paid consultant to Janssen Inc.



(1) ZYTIGA(®) Canadian Product Monograph. Page 3. September 6, 2013.

(2) Ibid.

(3) Ibid.

(4) Canadian Cancer Society. Canadian Cancer Statistics 2013. Available at:
http://www.cancer.ca/~/media/cancer.ca/CW/publications/Canadian%20Cancer%20Statistics/canadian-cancer-statistics-2013-EN.pdf. Last accessed January 31, 2014.

(5) The “Prostate Cancer – Quality of Life Patient and Caregiver Study” was
conducted through an online survey by Leger Marketing between June 21st
and July 7th, 2013 with 517 Canadian men who currently have or have had
prostate cancer and 256 caregivers.

(6) Bellmunt J, Charles J, Albanell J. Predictive modelling in
hormone-refractory prostate cancer (HRPC). Clin Transl Oncol. 2009

(7) Canadian Cancer Society. Prostate Cancer Statistics at a glance.
Available at: http://www.cancer.ca/en/cancer-information/cancer-type/prostate/statistics/?region=sk. Last accessed January 28, 2014.

(8) ZYTIGA(®) Canadian Product Monograph. Page 7. September 6, 2013.

SOURCE Janssen Inc.

Source: PR Newswire

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