Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of
Dutasteride for Prostate Cancer Prevention

Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.

Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”

The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.

“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”

The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).

Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.

The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.

“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”

As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.

Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”

About Prostate Cancer

Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.

About Dutasteride

Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.

Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.

In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).

About the Prostate Cancer Roundtable

The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.

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The above statement has been issued on behalf of and endorsed by

American Urological Association Foundation