Healthy Skepticism Library item: 10846

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Publication type: news

Stark K.
Trading shots over a vaccine
The Inquirer (Philadelphia) 2007 Jul 8
http://www.philly.com/philly/business/20070708_Trading_shots_over_a_vaccine.html

Full text:

Merck and GlaxoSmithKline are in fierce competition to develop the world’s top cervical-cancer immunization.

In the decades-long race to make the world’s leading cervical-cancer vaccine, Merck’s Gardasil has taken a big lead.

The vaccine is on pace to be a billion-dollar seller in the United States after one year on the market.

GlaxoSmithKline’s Cervarix remains at the starting gate, and likely will not receive U.S. approval until early 2008 – 18 months after its rival.

But GlaxoSmithKline P.L.C. could gain European approvals in the next month or so. The company is trying to leapfrog its competition by funding a rare, head-to-head clinical trial with Gardasil, with results expected early next year.

“Eighteen months is not a long time in life,” said GlaxoSmithKline’s Belgium-based vaccine chief, Jean Stephenne, as he visited the company’s Philadelphia headquarters last week. He recalled how GlaxoSmithKline’s hepatitis B vaccine became a market leader in the late 1980s after overcoming a three-year head start by Merck & Co. Inc.

The HPV-vaccine wars represent something of a Philly throwdown. GlaxoSmithKline is overseeing its trial from offices in King of Prussia, about 13 miles from Merck’s West Point plant, where the Gardasil marketing campaign is being waged.

The struggle shows how complicated vaccine discovery has become. These vaccines took several decades of research discoveries in labs across the world – from the University of Queensland in Australia to the Penn State College of Medicine in Hershey – to attract capital and produce products ready for sale.

The competition also indicates another trend: The venerable vaccine field is hot again after decades of decline because of low profit margins and litigation fears. Analysts predict that the $14.9 billion of worldwide vaccine sales in 2006 will double by 2010 and triple by 2013.

Driving the rise is the emergence of new threats, from the SARS respiratory virus to Ebola hemorrhagic fever. A factor, too, is the recognition that vaccines can offset rising health costs by offering the cheapest and most effective form of disease protection.

“If you look at Bill Gates, where is he putting his money?” asked Charles Dunton, director of gynecologic oncology at Lankenau Hospital in Wynnewood. “It’s in vaccines because he sees that it can have a much wider effect.”

Cervical cancer represents a prime target, because it is the second-most-common cancer among women worldwide.

To get cervical cancer, women first are infected with human papilloma virus (HPV), often considered the most common sexually transmitted disease. Most women clear these infections naturally. But in some cases, the infections are persistent and progress into precancerous lesions, genital warts – and, more rarely, cervical cancer.

In the United States, about 60 million Pap smears a year help identify these changes before they develop into full-blown cancer so they can be removed by a variety of means. Still, about 3,700 U.S. women die each year of cervical cancer.

The toll is far greater in the developing world, where Pap smears are nonexistent and more than 240,000 women are thought to die each year.

The HPV virus has proved a remarkably variable foe. Researchers have identified more than 100 separate genetic types, including about 40 found in the genitals. Some produce harmless but unpleasant warts, while about 15 to 20 play a role in cervical cancer. Studies show that the types HPV16 and HPV18 account for 70 percent of cervical cancers.

Noting these developments, Merck took a broad approach with Gardasil: It includes protection against the two most common cancer types – HPV16 and HPV18 – as well as two types linked to genital warts – HPV6 and HPV11.

GlaxoSmithKline’s Cervarix protects against only the two cancer types.

The company maintains that its narrower focus makes it better-suited for fighting cancer, the most important health concern. A study published last month in the British journal Lancet showed that the vaccine was affording some protection against cancerous types beyond HPV16 and HPV18.

But a half-dozen experts said they had seen no evidence of a Cervarix advantage so far. The consensus view was that the vaccines were even on cancer, and that Merck might gain a temporary edge from its genital-wart coverage.

“If I had a choice, I would take the Merck vaccine, because of the extra protection,” said Hildegund C.J. Ertl, founding director of the Wistar Institute Vaccine Center, an independent research group on the University of Pennsylvania campus. She said she had no financial ties with either firm.

Merck is pressing its potential advantage by testing an HPV vaccine that blocks eight virus types, double that of Gardasil. That version is in Phase 2 trials, still early in the approval process.

The choice could come down to price, said Enrique Hernandez, chairman of obstetrics and gynecology at Temple University Hospital, who has served on advisory boards to both firms.

“Whoever comes out with a cheaper product wins,” Hernandez said. “I don’t think there’s a significant difference between the two.”

Merck is asking $360 for Gardasil’s three injections, which are given over six months. And that does not include the doctor’s fee to dispense it.

Merck was widely criticized not only for the vaccine’s price but also for its early marketing campaign, now on hold, that aggressively lobbied states to require Gardasil shots.

Many people worry that Gardasil could encourage unprotected sex, a view the company disputes.

Neither vaccine works if women already have been exposed to the virus. That is why the American Cancer Society is recommending Gardasil for women up to 18, and suggests that older women consult their doctors.

“It’s hugely important to keep doing Pap smears,” said Michael A. Bookman, a medical oncologist and vice president of ambulatory care and clinical research at Fox Chase Cancer Center.

The science behind the vaccines took years to assemble.

A key technical discovery was how to make a hollow virus that primed the immune system without causing infection. Both of these HPV vaccines are among the first described as using “viral-like particles,” which came from several researchers, including a team at the National Cancer Institute with senior investigator John Schiller.

“There’s going to be a bit of an arms race between Merck and GSK,” Schiller said. “I wouldn’t be surprised if GSK adds the wart types.”

In the early to mid-1990s, Merck and the biotech firm MedImmune Inc. both launched efforts at competitive cervical-cancer vaccines. Merck started making a Gardasil prototype in 1996 and began clinical trials the following year. A key study in 2002 showed that the vaccine prevented lesions.

GlaxoSmithKline got a later start. Claudine Bruck, who was a research and development manager at the time, heard tantalizing details about viruslike particles at a 1996 conference in Brisbane, Australia. She realized the science was in place to move forward, especially after GlaxoSmithKline ended up buying MedImmune’s vaccine effort in 1997.

“That made it very exciting,” she said. “This was a nut we could crack.”

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At a Glance: HPV Vaccines
Gardasil

Merck & Co. Inc. got FDA approval June 8, 2006.

Protects against four virus types: HPV16 and HPV18 for cervical cancer, and HPV6 and HPV11 for genital warts.

Costs: $360, plus doctor’s fees.

Cervarix

GlaxoSmithKline P.L.C. is awaiting FDA approval, expected in early 2008.

Protects against two virus types: HPV16 and HPV18 for cervical cancer.

Note: Neither vaccine works in women already infected with HPV, so continuing Pap smears is essential.

SOURCES: Listed companies, Food and Drug Administration

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Contact staff writer Karl Stark at 215-854-5363 or kstark@phillynews.com.