Another set-back for the "leaders" to be proud of

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Merck loses fight for Gardasil use in older women

April 7, 2011 — 9:53am ET | By Tracy Staton



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In a blow to Merck's campaign to expand use of its human papillomavirus vaccine, the FDA denied the drugmaker's request to market Gardasil to older women. The vaccine is currently approved for girls who are at least 9 years old and for young women up to the age of 26, as well as for boys and young men.

Merck had been on a roll, winning bids to expand Gardasil use beyond its initial indication for prevention of cervical cancer and genital warts in girls and young women. Merck got the FDA nod for Gardasil as a shield against vulvar and vaginal cancers in the same age group, then won the OK to market it as a preventive for genital warts in boys and young men. Last December, the FDA approved Gardasil as a preventive for anal cancers.

But the expansion of Gardasil's label to cover older women has remained stubbornly elusive. In 2009, the FDA put off Merck's request, asking for more data. The company submitted more data early in 2010, but then the FDA postponed its decision. And now, instead of approving the new use, FDA asked Merck to revise the label to say that Gardasil has not proven effective at reducing HPV-related cervical cancers in women over the age of 26.

Merck had been counting on the new use to help reverse a sales slide. Last year's sales of $988 million were down 12 percent from the previous year, Bloomberg reports. As Pharmalot notes, Gardasil brought in $1.48 billion in 2007, $1.4 billion in 2008, and $1.1 billion in 2009.



Read more: Merck loses fight for Gardasil use in older women - FiercePharma http://www.fiercepharma.com/story/m...m_medium=nl&utm_source=internal#ixzz1Ir5Ekn6j
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Anonymous said:
Merck loses fight for Gardasil use in older women

April 7, 2011 — 9:53am ET | By Tracy Staton



RELATED STORIES
CDC reconsiders HPV vaccine use in boys
Aiming for Canadian sales, GSK cuts Cervarix price
FDA puts off decision on Merck's Gardasil--again
Only 34% of girls got Merck's HPV shot, study finds
NY lawmakers mull HPV vax mandate
TOOLS
Subscribe
Email
Print
Comment
Contact Author
Reprint
In a blow to Merck's campaign to expand use of its human papillomavirus vaccine, the FDA denied the drugmaker's request to market Gardasil to older women. The vaccine is currently approved for girls who are at least 9 years old and for young women up to the age of 26, as well as for boys and young men.

Merck had been on a roll, winning bids to expand Gardasil use beyond its initial indication for prevention of cervical cancer and genital warts in girls and young women. Merck got the FDA nod for Gardasil as a shield against vulvar and vaginal cancers in the same age group, then won the OK to market it as a preventive for genital warts in boys and young men. Last December, the FDA approved Gardasil as a preventive for anal cancers.

But the expansion of Gardasil's label to cover older women has remained stubbornly elusive. In 2009, the FDA put off Merck's request, asking for more data. The company submitted more data early in 2010, but then the FDA postponed its decision. And now, instead of approving the new use, FDA asked Merck to revise the label to say that Gardasil has not proven effective at reducing HPV-related cervical cancers in women over the age of 26.

Merck had been counting on the new use to help reverse a sales slide. Last year's sales of $988 million were down 12 percent from the previous year, Bloomberg reports. As Pharmalot notes, Gardasil brought in $1.48 billion in 2007, $1.4 billion in 2008, and $1.1 billion in 2009.



Read more: Merck loses fight for Gardasil use in older women - FiercePharma http://www.fiercepharma.com/story/m...m_medium=nl&utm_source=internal#ixzz1Ir5Ekn6j
Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma
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I read the news today oh boy!! About an unlucky company that didn't make the grade...And though the news was rather sad...Well, I just had to laugh...
 












Take heart people. It might just be a blessing in disguise. Look what happened to us when we attempted to market VIOXX as first line therapy for EVERY BODY, not just those at increased risk of GI bleeds.
 






What sales curve would you expect for vaccines unless the you are dealing with a new strain every year, such as is the case with influenza? How much smallpox vaccine is sold these days? And with the credibility of pharma at a historical low, (most) doctors, patients, and the regulatory agencies are particularly suspicious of pushing these products outside of the useful envelope. A billion/year on such a mature product (especially when it was pushed as aggressively as Gardasil) is pretty OK. At some point the new customer base rate will be a stable % of the birth rate, which is now relatively low. The immigration rate is dominated by Latinos, who one might expect to have a lower uptake rate for prophylaxes related to STD because of the influence of the Catholic Church.
 






"Merck had been counting on the new use to help reverse a sales slide. Last year's sales of $988 million were down 12 percent from the previous year, Bloomberg reports. As Pharmalot notes, Gardasil brought in $1.48 billion in 2007, $1.4 billion in 2008, and $1.1 billion in 2009".

I am laughing as I have sold Merck vaccines for years and have never seen sales go down year after year. Way to go our fearless leaders. I would follow you no where!
 






The immigration rate is dominated by Latinos, who one might expect to have a lower uptake rate for prophylaxes related to STD because of the influence of the Catholic Church.

Laughable...given the reputation of Latinos when it comes to sex. They should be one of the first to line up for Gardasil.
 






Anonymous said:
The immigration rate is dominated by Latinos, who one might expect to have a lower uptake rate for prophylaxes related to STD because of the influence of the Catholic Church.
Click to expand...

Dumb statement considering the fact that Latinos can be agnostic, Catholic, Protestant, etc. Why not say white trash or ghetto kids then?
 






Anonymous said:
"Merck had been counting on the new use to help reverse a sales slide. Last year's sales of $988 million were down 12 percent from the previous year, Bloomberg reports. As Pharmalot notes, Gardasil brought in $1.48 billion in 2007, $1.4 billion in 2008, and $1.1 billion in 2009".

I am laughing as I have sold Merck vaccines for years and have never seen sales go down year after year. Way to go our fearless leaders. I would follow you no where!
Click to expand...

Of course the falling sales numbers, despite increased indications, is on the backs of our valued sales force, or what is left of them. No blame can be stuck on management as that is the way it goes.
 






Anonymous said:
Of course the falling sales numbers, despite increased indications, is on the backs of our valued sales force, or what is left of them. No blame can be stuck on management as that is the way it goes.
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Makes you think back when we had no NCM, no bursting product bags and no guaranteed defeat from competencies. Selling was selling and professionals could shine. Now its the dog eat dog rep who dominates and whoever can put on the best competency show
for the manager wins a better rank and might get to keep their job a little longer. Joke of it all is that the trappings aint bringin home the bacon to Mother after all.
 






Anonymous said:
Makes you think back when we had no NCM, no bursting product bags and no guaranteed defeat from competencies. Selling was selling and professionals could shine. Now its the dog eat dog rep who dominates and whoever can put on the best competency show
for the manager wins a better rank and might get to keep their job a little longer. Joke of it all is that the trappings aint bringin home the bacon to Mother after all.
Click to expand...

There was no way to save the Titanic either....can't take any of this seriously....just go thru the motions, pick up the paycheck until your number is up...and in the meantime put "plan B" in place.
 






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