Glaxo Compares Sex Virus Shots, Delay Raises Eyebrows

-Bloomberg

04/23/2009 - GlaxoSmithKline Plc will release the first study to compare its cervical cancer vaccine with Merck & Co.’s blockbuster Gardasil, more than a year after completing the research.

Sales for Glaxo’s Cervarix amount to less than 10 percent of those garnered by Merck’s similar vaccine. The comparison study may influence which product doctors use and insurers pay for. It will be presented for the first time at a medical meeting in Malmoe, Sweden, on May 10, according to a draft of the program obtained by Bloomberg News.

The study also will help governments determine which of the vaccines to select for immunizing women, influencing a global market that Glaxo estimated at more than $10 billion last year. Glaxo’s shot, used less often than Gardasil in Europe, hasn’t won approval in the U.S., where Merck began selling its version three years ago.

Glaxo’s decision to wait 14 months to release the data and pick a little-known medical meeting as the venue “certainly has both my eyebrows up,” said Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, in Philadelphia.

“Half the world is waiting to see which vaccine is the better one,” Caplan said. “You have a huge ethical obligation to get information out quickly. I’m never a fan of releasing key findings on a highly contentious issue, such as who’s got the better vaccine, at a relatively unknown meeting.”

The study concluded in March 2008, according to its listing on the U.S. government database that tracks clinical trials.

Two Studies

Cervarix and Gardasil protect women against the sexually transmitted human papillomavirus. The virus can lead to cervical cancer, which kills 250,000 women each year.

Stephen Rea, a spokesman for Glaxo in London, said the company chose the International Papillomavirus conference in Malmoe because it’s “internationally renowned and has a reputation for scientific rigor.”

Glaxo also plans to release another key Cervarix study, known as HPV-008, which tracks the effect of the vaccine on more than 18,600 women, at the meeting. U.S. regulators will use the findings to determine whether to clear the shot later this year. The company wanted to present the two studies “as a package,” Rea said. “Attendees will be able to see presentations on the efficacy study and the head-to-head study” together, he said.

Glaxo needs Cervarix to help offset cheaper generics that eroded U.S. sales of four medicines last year. Profit fell in the past two quarters at the London-based company.

‘Long Delay’

Glaxo shares have dropped 21 percent so far this year, the second-worst performance in a Bloomberg index of 18 European pharmaceutical companies. They fell 31.5 pence, 3 percent, to 1,019.5 pence in London trading, the biggest drop in a month.

Glaxo’s head-to-head study, dubbed HPV-010, measures which vaccine sparked a greater immune system response in more than 1,000 women seven months after the shot.

That means the results won’t say which product works best to keep cancer at bay, though it’s the first indication of the body’s ability to defend itself, said Aaron S. Kesselheim, an expert in pharmaceutical epidemiology and economics at Harvard Medical School and Brigham and Women’s Hospital in Boston. As such, it will help governments decide which product to pick, Caplan said.

“I can’t explain the long delay,” Kesselheim said. “If you have positive results, wouldn’t you want to get it out? If it’s negative, people should know that soon. It’s concerning to me that the turnaround time for getting the data out there is so slow.”

Spitzer Settlement

Glaxo may have taken longer to analyze the research to see whether women were protected against other strains of the virus than the ones contained in the shot, according to Nick Turner, an analyst at Mirabaud Securities in London.

The company has won exclusive contracts to provide Cervarix to young girls and women in the Netherlands and the U.K. since the study was completed. A spokesman at the U.K. Department of Health did not return calls seeking comment. Saskia Hommes, a spokeswoman for the Dutch Ministry of Health, said Cervarix was “cost effective.”

One dose of Cervarix costs about 112 euros ($145) in Europe, compared with about 124 euros for Gardasil. Women need three injections to be protected.

Glaxo, Europe’s fifth-largest drugmaker, has come under fire before for not promptly disclosing study results. When the company found that its Avandia diabetes medicine raised the risk of heart attacks in 2005, it submitted the findings to regulators and posted them on its Web site. It didn’t notify doctors or patients.

Glaxo’s Gamble

Glaxo agreed in 2004 to release the findings of all the studies it funds 10 months after completion for approved drugs after former New York Attorney General Eliot Spitzer accused the company of withholding data on the use of its Paxil medicine for childhood depression. Alex Detrick, a spokesman for the Attorney General’s office, didn’t return half a dozen phone calls and e- mails seeking comment.

Glaxo took a gamble by commissioning the Cervarix study. Drugmakers seldom embark on such research for fear their treatment won’t come out ahead, according to Kesselheim.

“No one wants the risk that their product will turn out poorly,” he said.

Cervarix has potential advantages, including longer protection that may reduce the need for booster shots, said Evan Myers, a professor of obstetrics and gynecology at Duke University Medical Center. Myers, who’s participated in clinical trials for Gardasil, says it offers patients broader protection.

Gardasil Sales

Cervarix, approved in more than 60 countries, had sales of 125 million pounds ($182 million) last year. Gardasil, sold in 109 countries, generated $1.4 billion for Whitehouse Station, New Jersey-based Merck.

Sales of Gardasil fell 33 percent worldwide to $262 million and 39 percent in the U.S. in the first quarter, Merck said yesterday. Gardasil, approved in 2006 in girls and women ages 9 to 26, hasn’t been embraced for older girls within that age group, Merck said.

“We are not satisfied with the performance and we continue to develop and implement programs to drive use of this important vaccine,” Ken Frazier, Merck’s president of global human health, said in a conference call with analysts yesterday. “It is important to keep in mind that where physicians have a choice of HPV vaccines, Gardasil is selected the vast majority of the time.”

If you or a loved one have experienced serious side effects as a result of the Gardasil HPV vaccination such as blood clots, paralysis, seizures, or other Gardasil side effects, you may be entitled to compensation. Pregnant women who suffered a miscarriage or fetal abnormalities following the administration of Gardasil, should contact one of our Gardasil side effect lawyers in order to protect your rights. For more information about a potential Gardasil lawsuit, or Gardasil side effects, fill out our free case evaluation form or call the toll-free number listed below today.