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May 2008
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2nd HPV Vaccine in the works

LJ-SEC: (ORIGINALLY POSTED BY [info]vanar_en_daeor)

If you recall, I said that I wanted to find information on vaccinating those outside of the recommended 9-26 age range of the Gardasil vaccine (made by Merck). Competitor GlaxoSmithKline is working on an HPV vaccine that may help those of us above 26 (I just turned 30 in May). It is worth keeping an eye on.

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Glaxo HPV vaccine shows promise for women 26-55
Mon Jun 5, 2006 10:18 AM ET

ATLANTA (Reuters) - An experimental cervical cancer vaccine made by GlaxoSmithKline Plc produced immune responses in all women ages 15 to 55 in a clinical study, the first evidence that a cervical cancer vaccine may work in women ages 26 and older, the company said on Monday.

The vaccine, called Cervarix, is designed to prevent infection with the human papilloma virus, or HPV, which causes most cervical cancer.

Researchers in the Phase 3 trial studied 666 women who received Cervarix injections and found 100 percent of them had developed antibodies to the two HPV types the vaccine targets, Glaxo said in a statement. The antibodies were detected seven months after the first of three doses and remained 12 months after the first shot.

Antibody levels were greater or equal to what was seen in females age 15 to 25 in other studies, which have shown 100 percent protection for 4.5 years against the two HPV strains and associated cervical lesions, Glaxo said.

The vaccine was "generally safe and well-tolerated," Glaxo said.

"These are important data as older women remain at significant risk of acquiring infections with cancer-causing HPV types," said Dr. Tino Schwarz, a professor at Stiftung Juliusspital Wuerzburg in Germany and the study's lead author.

The findings were presented at a meeting of the American Society of Clinical Oncology in Atlanta.

Glaxo is lagging rival Merck & Co. Inc. in developing a vaccine for cervical cancer.

Merck is expected to win U.S. approval for its Gardasil experimental vaccine this week based on earlier studies showing it was effective in women and girls ages 9 to 26. Glaxo has said it plans to apply for U.S. approval later this year.

At the same meeting in Atlanta, researchers presented data showing Merck's Gardasil was 100 percent effective at preventing pre-cancerous growths in the vagina or vulva caused by two HPV strains. It also was 81 percent effective at preventing the same conditions if they were caused by any HPV type, said Dr. Jorma Paavonen, the study's lead author and chief physician at the University of Helsinki's obstetrics and gynecology department.

Researchers based the conclusions on data from three clinical trials of more than 18,150 women given either Gardasil or a placebo.


http://today.reuters.com/news/newsarticle.aspx?type=healthNews&storyid=2006-06-05T141814Z_01_N05282016_RTRUKOC_0_US-CANCER-VACCINE-HPV.xml&src=rss


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I also found another article that suggests that Cervarix's protection may last longer than Gardasil's.

Analysis: Will Gardasil nod boost rival?
By Steve Mitchell May 22, 2006, 21:43 GMT

WASHINGTON, DC, United States (UPI) -- Last week`s recommendation from a Food and Drug Administration advisory panel that Merck`s cervical cancer vaccine Gardasil should be approved may also be a win for GlaxoSmithKline`s competing vaccine Cervarix.

'I think it`s positive on many levels,' Seymour Pierce analyst Sav Neophytou told United Press International.

'It means the FDA has gained experience looking at this kind of vaccine ... and will enable them to look at the Glaxo dossier in a more expedited manner,' Neophytou added. It could also enable FDA to look at Glaxo`s phase 3 trials before they finish.

He noted that the data on Cervarix 'provides a compelling profile.'

The FDA`s Vaccine and Related Biological Products Advisory Committee last week unanimously recommended Gardasil be approved for use in females between the ages of 9 to 26. The FDA is not bound by the recommendations of its advisory committees, but the agency generally follows their advice. The FDA should issue a final decision by June 8.

Both Gardasil and Cervarix prevent infection with strains of human papilloma virus that cause about 70 percent of all cases of cervical cancer.

Navid Malik, an analyst with Collins Stewart, told UPI that Glaxo`s vaccine may ultimately trump Merck`s by a couple of billion dollars in sales.

'The forecasts for Merck`s vaccine are too high at $2-4 billion and the consensus forecasts for Glaxo`s vaccine are too low,' Malik said.

Malik raised his forecast for Cervarix from $4 billion to $5.5 billion due to FDA comments released last week about Merck`s Gardasil.

The comments by an FDA medical reviewer 'highlighted a couple of issues that are advantages for GSK`s vaccine and disadvantages for Merck`s product,' Malik said.

This includes that the 'immune response for Merck`s vaccine declines over time,' he said. 'The risk is you can have the emergence of the virus over time.' In particular, 'the antibody to HPV type 18 seems to be diminishing after 3 or 4 years,' which is important because this subtype together with 16 are the cause of the majority of cervical cancers, he said.

Cervarix, on the other hand, seems to offer longer lasting protection that may persist for 15 years.

'Cervarix`s immune response is very strong even five years out ... and Glaxo has said it has the potential to be a one-off jab over 15 years,' Malik said. If that holds true, 'there`s no way a competitor product that requires boosters could ever compete,' he said. Gardasil is administered in 3 shots over 6 months.

Still, both vaccines will rake in a few billion dollars in sales. 'But Glaxo sales will be much more momentum-based,' Malik said.

'I really do think Glaxo will play very strongly to these points of differentiation,' he said, noting that he talked with company officials and 'could sense the joy in their tone now that they know there are points of differentiation they can argue against.'

Another advantage for Cervarix is that combining it with an adjuvant might enable the use of less vaccine. 'So it might even have a costs of goods advantage,' Malik said.

One challenge Glaxo faces is that it has not yet filed a new drug application with FDA, so its vaccine will be second to market. But Malik said he didn`t think that would hurt Cervarix given what he sees as its advantages over Gardasil. He also noted that there have been other latecomer products that have gone on to overcome those that were first to market, such as Pfizer`s Lipitor, which beat Merck`s Zocor.

Another advantage Glaxo has is that it is fast becoming a dominant force in the vaccine arena. In addition to Cervarix, the company is also developing a vaccine for the H5N1 strain of bird flu that looks very promising, Malik said.

'If I was playing this market, I wouldn`t invest in any other vaccine player today except Glaxo,' Malik said. Referring to Roche as the 'king of antibodies,' he said, 'Glaxo is going to become the Roche of vaccines.'

John Lebbos, an analyst with Decision Resources, told UPI Merck`s Gardasil may have an edge in that it also prevents infection with strain of the human papilloma virus that cause genital warts.

'That could be a clear advantage, but beyond that, it`s not clear there`s any efficacy advantage between the two vaccines,' Lebbos said.

Copyright 2006 by United Press International

http://news.monstersandcritics.com/health/article_1165920.php/Analysis_Will_Gardasil_nod_boost_rival

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