http://prostatecancerinfolink.net/2010/12/29/second-study-confirms-data-on-p
sadt-and-survival-post-surgery/

* Only PSA doubling time (™9.0 months vs 3.0-8.9 months vs < 3.0
months) remained independently predictive of overall and/or metastasis-free
survival in multivariate analysis.

The authors note that - based on this data set - overall and metastasis-free
survival "can be extensive for men with PSA-recurrent prostate cancer, even
in the absence of further therapy before metastasis."

In other words, men with a PSA doubling time > 9 months after initial
biochemical failure have a high probability of long-term metastasis-free
survival, which may call into question the value of any form of second-line
therapy until there is clear evidence of the presence of metastatic disease.

Link is also available on the VPCC Facebook page.

Abiraterone Acetate Update

Marketing application also submitted to European Health Authorities
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.

Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.

Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.

"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."

If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.

About Metastatic Advanced Prostate Cancer

Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.

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. 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 tumor, prostate cancer can also grow very quickly and spread widely.

Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.

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.

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 Johnson & Johnson Pharmaceutical Research & Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.

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

Ortho Biotech Oncology Research & Development, 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 J&JPRD, in the research and development of oncology and supportive care treatments.

(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 materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. 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. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.

Aspirin Therapy and Seniors'\Sexual Activity

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Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief


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Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis

Sex Remains Important to Many Elderly Men

NIH Issues Guidelines on Managing Food Allergies

Featured in Journal Watch: Suicide Attempts in the Population — What Counts?


Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis


Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.


Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)


Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).


In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.


Lancet article (Free abstract)

Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)





Sex Remains Important to Many Elderly Men


Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.


Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)


Among the findings:


Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.

Annals of Internal Medicine article (Free abstract)

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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.

###

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

American Urological Association Foundation