Sorry if this has been posted already but I haven't had time to catch up today.

Moffitt called me yesterday and wanted me to be interviewed by a local cable station running this story. They are also interviewing Dr Anna Giuliano, a HPV researcher at Moffitt. I was interviewed for about 2 hours so I guess they will whittle that down to 2 seconds. lol It will air tonight on Bay News 9 and they usually keep it airing every hour on the hour for 24 hours. I will post it when it is available unless they make me look bad!!

Here's the News Release:

FOR IMMEDIATE RELEASE
Media Contacts: Pam Eisele Investor Contacts: Eva Boratto
(908) 423-5042 (908) 423-5185
Jennifer Allen Carol Ferguson
(215) 652-0572 (908) 423-4465
FDA Advisory Committee Recommends Approval for Use of GARDASIL�
in Boys and Men
Committee Agrees that Clinical Data Support the Efficacy and Safety of Merck�s GARDASIL
in 9- to 26-Year-Old Boys and Men
WHITEHOUSE STATION, N.J., Sept. 9, 2009 � Merck & Co., Inc. announced today that the U.S.
Food and Drug Administration�s (FDA) Vaccines and Related Biological Products Advisory
Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males
support the use of GARDASIL� [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18)
Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital
warts caused by human papillomavirus (HPV) types 6 and 11.
"Merck has been committed to pursuing the use of GARDASIL in both males and females
since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice
president, and president of Merck Research Laboratories. "We are pleased that the Advisory
Committee agrees that the data support the use of GARDASIL in boys and men.�
The committee�s recommendation will be considered by the FDA in its review of the
supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in
December 2008. The FDA is not bound by the committee�s guidance, but takes its advice into
consideration when reviewing vaccines. Merck expects a decision from the FDA in the fourth
quarter of 2009 after the agency has completed its review of Merck's application.
�Today's discussion with the Advisory Committee brings the public health community closer
to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt
Cancer Center.
GARDASIL has been approved for use in the U.S. since June 2006 and is currently
indicated for use in girls and young women 9 through 26 years of age for the prevention of
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cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV
types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
More than 50 million doses have been distributed worldwide through June 2009, although the
number of doses administered is not known.
Data for use of GARDASIL in boys and men presented
Clinical trials presented to the Advisory Committee evaluated the efficacy, immunogenicity
and safety of GARDASIL in boys and men 9 to 26 years of age. Vaccine efficacy in males was
evaluated in a randomized, double-blind, placebo-controlled trial. A total of 4,055 men were
enrolled and received at least one dose of GARDASIL or placebo. Of these, 3,457 were
heterosexual men aged 16 to 23 years and 598 were men who have sex with men aged 16 to 26
years.
The per-protocol efficacy (PPE) population was the predefined primary population for the
demonstration of efficacy in 16- to 26-year-old men. As defined, this population included subjects
who were not infected with HPV vaccine types at the start of the study, nor did they become
infected with HPV vaccine types during the course of the vaccination series. These subjects were
seronegative and HPV DNA negative to HPV vaccine types at day one, and HPV DNA negative
through the vaccination series to month seven. This population also received the three shot series
within a one-year time period and generally did not deviate from the protocol. The cases of the
primary endpoint of external genital lesions (EGL) were counted starting after month seven.
Analyses were also conducted in the Full Analysis Set (FAS) population. The FAS
population included all participants who received at least one dose of vaccine or placebo and
endpoint cases were counted after day one, the day after the first dose of vaccine was given. The
key difference from the PPE population was that the FAS also included participants who had been
previously exposed, were already infected with HPV types, or became infected before the
completion of the three-dose vaccine series (not specific to 6, 11, 16 and 18).
Per protocol efficacy
In the PPE analysis, GARDASIL was 90.4 percent efficacious (95 percent CI: 69.2, 98.1)
against HPV 6, 11, 16 and 18-related EGL. Of 34 cases of EGL, 31 were genital warts. All cases
of genital warts were positive for HPV 6 and/or 11 (three cases in the vaccine group and 28 in the
placebo group). GARDASIL was 89.3 percent efficacious (95 percent CI: 65.5, 97.9) against HPV
6/11-related external genital warts.
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There were three cases of HPV 6/11/16/18-related penile/perianal/perineal intraepithelial
neoplasia (PIN) in the PPE analysis and all were in the placebo group. No cases of
penile/perianal/perineal cancers were observed in the vaccine or placebo groups during the study.
Although vaccine efficacy against HPV 6/11/16/18-related PIN 1 or worse was 100 percent (95
percent CI: <0, 100), there was no statistical significance due to the small number of cases seen in
the study.
Full analysis set
In the FAS analysis, GARDASIL was 65.5 percent efficacious (95 percent CI: 45.8, 78.6)
against HPV 6, 11, 16 and 18 EGL. Of 104 cases of EGL, 95 were genital warts positive for HPV 6
and/or 11 (24 cases in the vaccine group and 71 in the placebo group). GARDASIL was
66.8 percent efficacious (95 percent CI: 46.5, 80.0) against HPV 6/11-related external genital warts
in this analysis.
Immunogenicity
In immunogenicity studies, GARDASIL generated robust immune responses to HPV types
6, 11, 16 and 18 in 9- to 15-year old boys and 16- to 26-year old men.
Immunobridging studies in 9- to 15-year old boys demonstrated that boys had
approximately two to three fold higher HPV type-specific antibody levels at month seven compared
to 16- to 26-year old men. These data established the non-inferiority of the peak immune response
as measured at month seven for all four HPV-types in boys as compared to men.
Safety data for GARDASIL
Compared with placebo recipients, a slightly higher proportion of vaccinees reported
injection site (64.1 percent GARDASIL; 53.6 percent placebo) and systemic adverse experiences
(37.2 percent GARDASIL; 32.6 percent placebo), the majority of which were reported as mild to
moderate intensity. Subjects who reported a severe intensity systemic adverse experience and/or
an injection-site adverse experience were comparable between the two groups (systemic adverse
experiences reported: 4.3 percent in the GARDASIL group versus 3.0 percent in the placebo
group; injection-site adverse experiences reported: 2.0 percent in the GARDASIL group versus 1.0
percent in the placebo group). Overall, the safety profile observed in boys and men 9 to 26 years
of age in clinical studies was consistent with the safety profile observed in clinical studies in girls
and women 9 to 26 years of age.
Important information about GARDASIL
GARDASIL does not substitute for routine cervical cancer screening, and women who
receive GARDASIL should continue to undergo screening.
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GARDASIL has not been demonstrated to provide protection against diseases from vaccine
and non-vaccine HPV types to which a woman has previously been exposed through
sexual activity. GARDASIL is not intended to be used for treatment of active genital warts;
cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial
neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).
GARDASIL has not been demonstrated to protect against diseases due to HPV types not
contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL
protects only against those vulvar and vaginal cancers caused by HPV Types 16 and 18.
Select safety information
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic
reactions to yeast, or after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in falling with injury,
observation for 15 minutes after administration is recommended. Syncope, sometimes associated
with tonic-clonic movements and other seizure-like activity, has been reported following vaccination
with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually
transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were
observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than
placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and
bruising.
Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be
administered in three separate intramuscular injections in the deltoid region of the upper arm or in
the higher anterolateral area of the thigh. The following dosage schedule is recommended: first
dose at elected date, second dose two months after the first dose and the third dose six months
after the first dose.
About HPV
There are more than 100 types of HPV, of which about 30 to 40 types can infect the genital
areas of women and men. HPV types 6 and 11 cause approximately 90 percent of genital warts
cases. About one million people (both males and females) have visible genital warts at any point
in time. There are currently no routine HPV screening methods in place for men.
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GARDASIL is approved in 112 countries
GARDASIL (sold in some countries as SILGARD�) has been approved in 112 countries,
and additional applications are currently under review with regulatory agencies in many more
countries around the world.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting
patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets
vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts
to increase access to medicines through far-reaching programs that not only donate Merck
medicines but help deliver them to the people who need them. Merck also publishes unbiased
health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on management's
current expectations and involve risks and uncertainties, which may cause results to differ
materially from those set forth in the statements. The forward-looking statements may include
statements regarding product development, product potential or
financial performance. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together with the
many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in
any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-
Q or current reports on Form 8-K, which the Company incorporates by reference.
# # #
Prescribing information and patient product information for GARDASIL� is attached

David,

First of all, I am sure there is no way you would look bad. Second, I'm sure it will be at least 3 seconds.

Please post a link if it is on the internet.

Megan posted this on Facebook earlier today, so I got to read a brief version of what you posted. I've been telling my patients that this would probably happen sometime in 2009, so I guess I will maintain my credibility with my patients.

As exciting as this news is because we all know that this will ultimately lower the overall rate of new oral cancers in the future, I just can't understand why OC is NEVER mentioned as being caused by HPV.

Perhaps Brian will chime in here and shed some light on this subject.

Jerry

http://oralcancernews.org/wp/?p=6584

It's in the OCF news feed.

It didn't run Friday as they told me it would so I'll look for it Monday.

While every scientist in the HPV world agrees that the impact on H&N cancers will be the same as cervical, because Merck has not done a clinical trial to prove so, they cannot talk about the opportunity and potential. This is an FDA issue and not a science issue. The approval for genital warts, was easy to get through the FDA, but it will take time and money to get an H&N oral cancer approval, and likely 5 years or more to do so.

Bottom line is that third parties like OCF and others can make the science argument while Merck is prohibited from talking about it, and we routinely do. The only time I get flack for doing so at a cancer conference is from someone who is anally evidence based. There is no actual evidence other than the fact that we know that the vaccine prevents persistent HPV16 infections. We know that oral cancers are caused by persistent HPV16 infections, ergo it will prevent oral cancers logically. But the FDA requires an actual trial to demonstrate what is believed.

My personal belief is that if we start vaccinating boys we will see the numbers in rates of incidence decline. Definitive proof that the vaccine did it? No... but what else would account for the change? You have to remember that the dental community and even the cancer community is full of evidence based only people. If it has not been proven that he earth is round, than it is just as likely that it is flat, regardless of prevailing wisdom. The facts that lead to conclusions have to have a proven direct connection, not an extrapolated conclusion.

Here is the link to what was produced. It's amazing how short they can make complicated issues!! I could easily do a 30 minute talk show on HPV and it takes that just to get the reasonable intelligent facts out there. The good news is that they do run the same piece every hour on the hour for 24 hours.

BTW, the brown dog is Lamont, the one I said I would never keep, and the black n white is Buddy who I also fought against keeping. Guess I'm no good at saying NO to my wife.

http://www.baynews9.com/content/36/2009/9/12/520153.html

You're a terrific OCF spokesperson, David - too bad they didn't feature you for MORE of those 2 hours. Jane

Way to go David. You are quite telegenic.
charm

As usual David, great job. Every exposure to the public is a great accomplishment.

Keep up the good work.

Brian,

Thanks for the explanation of how these things work. I now have a better understanding of why OC is never mentioned.

Jerry

David

I've set my iGoogle to troll for news stories on "base of tongue cancer" and your newspaper interview came up on top of the list today. It independently searches for each word, so if anybody using Google news was tracking cancer, they will see it. Outstanding outreach considering Google news audience.
charm