Cervarix

GSK, Sanofi lobby Irish for HPV shots

Tracy Staton — Tue, 02 Dec 2008 10:51:52 -0500

Drugmakers are dispatching experts to the Emerald Isle to lobby for their human papillomavirus vaccines. That's because the Irish government has opted out of a comprehensive program to vaccinate young women against HPV, which can cause cervical cancer and genital warts. Instead, Ireland plans a screening program for cervical cancer in hopes of catching the disease early--and saving money in the process.

GlaxoSmithKline, which makes the Cervarix HPV shot, and Sanofi Pasteur, which markets Merck's Gardasil in Europe, say screening isn't enough. They're sending cervical cancer experts to speak to consultants and healthcare types about the benefits of vaccination. For instance, Sanofi dispatched Margaret Stanley of Cambridge University last week, and GSK is hoping to get Dr. Anne Szarewski, a clinical consultant at the Wolfson Institute of Preventive Medicine, in front of Ireland's health minister later this week.

A spokesperson for Minister Mary Harney told the London Times that an HPV vaccine program would play a role in Ireland's overall response to cervical cancer, but that vaccinating all young women isn't practical right now. "The decision not to proceed... is not based on the scientific evidence," the spokesperson said, "but is related to the need to prioritize scarce resources given the current state of the public finances."

But GSK takes issue with the Minister's cost estimates for a vaccine program, too. Claire Taaffe, a GSK spokeswoman, told the Times that the company thinks the cost would be lower than the 10 million euros government is quoting. Competitive bidding would cut that cost considerably, she said.

- read the story in The Times

Dutch probe GSK, Sanofi over HPV shots

Tracy Staton — Mon, 20 Oct 2008 10:17:33 -0400

Government officials in the Netherlands are investigating accusations that Sanofi-Aventis and GlaxoSmithKline were providing research funding to members of the country's Health Council, which advises the government on public health issues, at a time when the group was considering whether to have girls vaccinated against the human papillomavirus.

As you know, Sanofi-Aventis markets the HPV vaccine Gardasil in Europe in a joint venture with Merck. Glaxo sells Cervarix, its HPV vaccine, which hasn't yet received U.S. approval.

The Health Council recently recommended that girls should get shots to prevent HPV infection, which can cause cervical cancer and genital warts. But now, the Dutch Socialist Party wants Parliament to debate the issue. Party Chair Agnes Kant says the drugmakers have been too aggressive at marketing their vaccines. And she suggests that they've tried to influence the council's decision-making via funding.

Glaxo told Pharmalot that it's cooperating with the Dutch authorities, and that a lot of misinformation is going around in the Dutch media about the issue. The company is "taking steps to correct the false information." Stay tuned.

- read the post at Pharmalot

Is Gardasil worth the cost?

Tracy Staton — Thu, 21 Aug 2008 10:35:17 -0400

Are HPV vaccines worth the cost? A study in the New England Journal of Medicine concludes that they aren't--at least not for women over 18. They'll only be cost-effective, the resesarchers decided, if they're given to pre-adolescent girls, if they prove to protect girls for a lifetime (so far, they've only been studied for six and half years, so the jury's out) and if current methods of screening for cervical cancer using Pap smears can be adjusted to reduce costs, so that the $400 price tag for the shots can be recouped.

The study could be a blow to Merck's Gardasil and GlaxoSmithKline's Cervarix. Merck has already had some difficulty getting college-age and older women to get the vaccines, contributing to a slowdown in sales for Gardasil. And GSK, which hopes to introduce Cervarix in the U.S. this year, could find doctors and patients slow on the uptake. Plus, one of the companies' strategies has been persuading governments to push the shots, even make them mandatory, and in countries where governments control drug reimbursements, cost-effectiveness often comes into play.

In developed countries, Pap smear screening and treatment have cut cervical cancer deaths to very low levels already. And because the vaccines only protect against two of the cancer-causing strains, that sort of screening still needs to continue even in vaccinated patients. In fact, some women's health advocates have publicly worried that vaccinated women might get lax about their Pap smears, thinking they're in the free and clear because of the shot.

--read the story in the New York Times
--see the Wall Street Journal article

Glaxo's Cervarix delayed until late 2009

Tracy Staton — Mon, 30 Jun 2008 10:16:44 -0400

Call it a tale of two countries: Last week, the U.K. tapped GlaxoSmithKline's Cervarix as its preferred HPV vaccine, clearing the way for the National Health Service to put it on every young British girl's shot program. But in the U.S., the vaccine probably won't be OK'd for sale until late 2009.

Glaxo announced today that it handed over some Cervarix info to the FDA as the agency requested, but it has decided to augment its approval app with final data from a Phase III study. That data won't be ready until early next year, and review is expected to take some six months more. So the earliest date Cervarix might reach the U.S. market is more than a year away.

- read GSK's release

ALSO: In the wake of worries about Pfizer's Chantix stop-smoking med, GSK plans to step up advertising of its smoking cessation products. Report

U.K. inks HPV vaccine deal with Glaxo

Tracy Staton — Thu, 19 Jun 2008 10:39:40 -0400

Chalk up a vaccine win for GlaxoSmithKline. U.K. health officials have tapped GSK’s Cervarix as their official HPV preventative, passing over Gardasil, a longer-on-the-market shot marketed by Sanofi Pasteur and developed by Merck. Cervarix will be given to girls 12 and 13 years of age beginning in September.

But while GSK might be celebrating, some patient advocates aren’t. They’d been lobbying for Gardasil, which guards against two other strains of the cancer-causing human papilloma virus and also protects girls from genital warts. “Genital warts is the second most common sexually transmitted infection in the U.K. after Chlamydia,” said the Family Planning Association. “Selecting the Gardasil vaccine would've been a huge preventative measure in terms of health and financial costs to the NHS.”

But the government defended its choice, saying that it awarded the contract based on Cervarix’s score “against a number of pre-agreed criteria.” The GSK product, moreover, "offers best overall value to the NHS," officials said.

- read the story in The Times
- check out the BBC's coverage
- see the article for more

France picks Gardasil over GSK upstart

Tue, 15 Jan 2008 06:59:58 -0500

Gardasil captured more territory for Merck and Sanofi-Aventis yesterday when French health officials recommended that vaccine against Human Papilloma Virus, or HPV. The French authority recommended that girls of 14 be vaccinated against four strains of the virus, which Gardasil does; its rival Cervarix, made by GlaxoSmithKline, protects against only two. Cervarix targets two HPV strains that cause cancer; Gardasil aims at two cancer strains and two that cause genital warts.

It's just one more victory for Gardasil, which made it to market first, and gained all the attendant early-bird advantages. Though Cervarix is approved in a multitude of countries, it's not for sale in the U.S.; the FDA recently asked GSK for more info about the product. But GSK has been so confident in its product that it launched a head-to-head study pitting Cervarix against Gardasil. Results are expected later this year.

- get the report from CNN Money
- read about the U.S. CDC's recent purchase of 10 million Gardasil doses
- here's GSK's release about its Cervarix vs. Gardasil study

It's Crestor vs. Lipitor in AZ trial

Tue, 15 Jan 2008 06:59:55 -0500

If GlaxoSmithKline can challenge Merck to a head-to-head trial (Cervarix versus Gardasil), then AstraZeneca can throw down the gauntlet before Pfizer. In this case, the products in question are statins--AstraZeneca's Crestor and Pfizer's Lipitor. And the study, dubbed Saturn, will compare the two for their ability to decrease progression or induce regression of atherosclerosis over a two-year period. By the time the results are in, Lipitor will be going off patent, and the still-protected Crestor will need a performance edge to tout against cheap, copycat Lipitors.

Who knows, maybe the gamble will pay off. Maybe Crestor will trounce Lipitor and everyone at AstraZeneca will dance joyfully around the exec who came up with the idea for this trial. But the risks are considerable. For a cautionary tale, just consider Merck and Schering-Plough's roll of the Vytorin dice. Presumably, however, AstraZeneca won't hold back the trial results if they don't look good. At least we hope not.

- see this release from AstraZeneca
- read the article at MarketWatch

Related Articles:
Lipitor patent gets U.S. thumbs-down. Report
Lipitor is No. 1, but faces generic threat. Report
AZ hits back at Crestor imitators. Report

Brits to vaccinate schoolgirls against HPV

Fri, 26 Oct 2007 06:59:56 -0400

The British government just made Merck's day--or was it GlaxoSmithKline's? U.K. schoolgirls will be vaccinated against the human papilloma virus that causes cervical cancer. And it's not just the 12- and 13-year-olds initially recommended to get the shot, but young women up to age 18, too.

The government stopped short of recommending which version of the vaccine to use. Both Gardasil, made by Merck and Sanofi Pasteur, and Cervarix, made by Glaxo, are approved for use in the U.K. Glaxo's version launched only recently, while Merck has had more time to get a toehold in the market.

- read the story at the BBC's website

It's Merck v. Glaxo in vaccine battle

Thu, 04 Oct 2007 06:59:58 -0400

Call it the battle of the HPV vaccines. For the past week, either Merck's Gardasil or GlaxoSmithKline's Cervarix--or both--have captured headlines:

• Glaxo submits Cervarix for approval in Japan
• Merck donates millions of Gardasil doses for use in developing countries
• Glaxo applies for vaccine prequalification from the WHO
• Gardasil wins best new biotech product
• Cervarix approved for sale in Europe
• Merck hires PR firm to advocate for Gardasil
• Sanofi Pasteur files to extend Gardasil treatment

It's no mystery why the drug makers are jostling for ascendancy here. Estimates of the market for these vaccines run to several billions, even if their use was restricted to prevention of cervical cancer.

Now there's evidence that Gardasil may protect against cancers of the vagina and vulva, further bolstering its usefulness for women. Other research shows that HPV may cause throat and neck cancer in men, thus boys may need one of the vaccines, too--creating a whole new, unexpected market. So the stakes are even higher than they first seemed. And they were pretty darn high to start with.

- see GSK's release on WHO prequalification and the release on it's Japan app.
- check out Merck's press release on the Prix Galien
- read the article from PR Week
- see this Medical Marketing & Media article

Related Articles:
GSK prepares to go head-to-head with Merck. Report
Merck's Gardasil OK'd for pricey rollout. Report
Cervarix more effective in girls aged 10-14. Report
GSK stakes claim to ASCO spotlight. Report