Genital Warts Advisor

Merck’s Gardasil not cleared for older women

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• Author: Steven Johns
• July 11, 2008
• Category: hpv vaccine, vaccine

U.S. regulators have told Merck & Co they cannot yet approve Merck’s application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday.

Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are “issues” that preclude approval within the expected review time frame, Merck said.

“It’s hard to get a feel for if this is a dead issue or if this is delayed,” said Linda Bannister, an analyst for Edward Jones. “At the minimum, it’s going to be delayed.”

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the Human Papillomavirus that causes cervical cancer. The company for now is dropping plans to pursue that expansion, a spokeswoman said.

Shares of the New Jersey-based drug maker, which also reiterated its long-term revenue and earnings targets, fell 0.8 percent.

Gardasil, approved in June 2006 for preventing cervical cancer and genital warts in females ages 9-26, has been one of Merck’s most successful newer products and has helped the company recover after the 2004 withdrawal of its Vioxx arthritis treatment.

The Gardasil setbacks could raise concerns about the degree of growth that Merck can hope to achieve with the product, which is the world’s first vaccine to prevent cervical cancer.

A Merck spokeswoman said the agency has specific questions regarding Gardasil’s effectiveness in this older age group.
The company said it had already discussed the questions with the FDA and expects to respond to the agency in July.

“Once we go back to the FDA, we’ll have a better sense of what the review timing looks like,” spokeswoman Amy Rose said.

The agency’s response on the application for the older group does not affect Gardasil’s current approval for females ages 9 to 26, Merck said.

Global sales of Gardasil rose 7 percent in the first quarter to $390 million. Cowen and Co has predicted annual sales of the vaccine would reach $1.9 billion in 2008 and jump to $3 billion by 2012.

Edward Jones’ Bannister said she had expected Gardasil sales to reach $2.6 billion by 2012, with about one-third to come from that older age group.

Deutsche Bank analyst Barbara Ryan said failure to win approval for the older age group could reduce her $3.8 billion estimate for 2012 sales by about $300 million.

Ryan said the most important new opportunity for the vaccine will be for its use in males. The vaccine could help prevent males from contracting Human Papillomavirus and spreading it to females through sexual contact. Merck is on track to seek approval for use in males by the end of the year, Rose said.

Gardasil has benefited from lengthy delays in approval of GlaxoSmithKline’s rival Cervarix vaccine. The FDA in December issued a complete response letter for Cervarix, meaning it had completed its review of the product but had further questions about it.

Bannister said the Gardasil delay reflects broader challenges facing drug makers within the U.S. regulatory environment.
“It’s not specific to Merck,” Bannister said. “This is an industry-wide issue.”

Merck shares fell 29 cents to $36.74 in afternoon trading on the New York Stock Exchange. The shares have fallen some 37 percent this year, hurt by setbacks to its cholesterol franchise.

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Cervical Cancer Vaccines May Start Soon

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• Author: Steven Johns
• June 5, 2008
• Category: cancer, hpv, hpv vaccine, vaccine

A cervical cancer vaccine programme is likely to be introduced in the Republic in the near future, on foot of today’s publication of a Health Information and Quality Authority (Hiqa) report.

The HIQA value-for-money report should pave the way for the early announcement of a formal immunisation programme aimed at 12-year-old girls. The report also recommends a once-off vaccination programme for 13 to 15 year-olds.

Cervical cancer is caused by certain types of the human papillomavirus (HPV), with evidence of infection found in 99 per cent of women with cervical cancer.

The Minister for Health, Mary Harney has said she would introduce a HPV/cervical cancer vaccine programme if advised to do so.

Although there are in excess of 200 HPV strains, just a small number are associated with the development of cancer of the cervix. HPV types 16 and 18 are found in almost 70 per cent of cervical cancers, while another five sub types are responsible of a further 20 per cent of cases. Some HPV types are non cancerous but are linked to the presence of warts in the genital area.

Cancer of the neck of the womb (cervix) is diagnosed in almost 200 women here every year; some 70 women die from the disease annually.

Cervical cancer usually develops quite slowly, passing through a number of pre invasive stages (carcinoma in situ - CIN) before progressing to full blown disease. If caught in the early stages, it has a five-year survival rate of 80 per cent or greater.

HPV is a sexually transmitted infection; it is estimated that almost 80 per cent of sexually active people have been infected with at least one virus type by the age of 50. It is usually symptomless and in 90 per cent of cases, the body clears itself of the virus within two years of infection. But it is when the virus persists that the risk of cervical cancer increases.

Gardasil and Cervarix are the approved vaccines against HPV. Both aim to prevent cervical cancer; in addition Gardasil is active against those HPV subtypes known to cause genital warts. Both products involve a three-vaccine course, given over a six-month period. And clinical trials involving a five-year follow-up, have shown that vaccination is 100 per cent effective in preventing HPV infection and non-invasive cancer .

HPV vaccines must be given before infection with the virus occurs. This means administering the course prior to the person becoming sexually active so that a comprehensive vaccination program would need to be administered to girls in the 11- to 13-year age bracket.

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More links found between cancer in men and HPV, but men aren’t approved for vaccination

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• Author: Steven Johns
• June 5, 2008
• Category: cancer, hpv, hpv vaccine, vaccine

by Brian Boyer

Men are neither vaccinated nor screened for human papillomavirus, but two university studies suggested last week that it may be the cause of cancer for many men, and that those cancers could have been prevented.

The virus, better known as HPV, is the primary cause of cervical cancer in women. Recent research, at the University of Michigan and University of Louisville, suggests that it is also the cause of a disease that disproportionately affects men, cancers of the head and neck.

“You should be testing everybody,” said Payal Desai, leader of a pilot study at the Louisville’s James Graham Brown Cancer Center. Both men and women carry HPV, the virus that will affect at least 50 percent of sexually active people, according to the Food and Drug Administration, though only a fraction of those will develop cancer.

More than 35,000 new cases of head and neck cancer are expected to be diagnosed in the United States in 2008, according to the American Cancer Society. Twice as many men as women will develop the disease, which the society estimates will kill 7,590 Americans this year.

Currently a screening test only exists for women. Similarly, a vaccine for HPV exists, but is only approved for use in women ages 9 to 26. Studies are under way to test the efficacy of the HPV vaccine in men, according to the FDA.

If the vaccine were successful in preventing HPV infections in men, the studies suggest it is possible that a significant number of cancer cases in men could be avoided.

In one study, tissue samples from 43 head and neck cancer patients were tested by the Louisville team. They found that almost one-third of the samples tested positive for HPV, specifically the strain of the virus known as HPV 16.

In the other study, at Michigan’s Comprehensive Cancer Center, had similar findings. More than one-third of the 66 head and neck cancer cases they examined tested positive for HPV 16. This study’s primary finding was encouraging: The HPV-associated tumors responded significantly better to treatment than those not associated with HPV.

In women, HPV types 16 and 18 are responsible for 70 percent of cervical cancer cases. The American Cancer Society estimates that 11,070 cases will be diagnosed, and that the disease will kill 3,870 women in the United States in 2008.

Infection by strains 16 and 18 can be prevented through vaccination, with almost 100 percent effectiveness. The drug Gardasil, first made available to young women in 2006, also vaccinates against types 6 and 11, which are responsible for 90 percent genital warts cases.

Desai presented the findings of their study May 15 at the American College of Physicians Internal Medicine Conference. The results have not yet been published. The University of Michigan study was published online May 12 in the Journal of Clinical Oncology. In February, another study, at the National Cancer Institute and Johns Hopkins Medical Insitutions, suggested a link in men between HPV and oral cancer.

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