Anthrax: serious business | Page 2 of 3

Anthrax: serious business

Can we breathe easy yet? An examination of how safe we are as two local firms battle it out to develop a next-generation vaccine

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Infection occurs in one of three ways: cutaneously (exposure through open cuts, which is considered the easiest to treat); through consumption of infected meat (increasingly rare with advances in food processing and inspection); and via inhalation, which would come into play in a bioterror attack.

Nearly half of those diagnosed with inhalational anthrax after the 2001 attacks died, although the fatality rate historically has been even higher, according to federal health officials. With inhalational anthrax, the bacteria infect the lungs and spread to lymph nodes in the chest, producing toxins. Symptoms—fever, nausea, vomiting and fatigue—usually appear one to seven days after exposure, with labored breathing and shock occurring as the disease progresses.

In 1979, anthrax was accidentally released from what is believed to have been a biowarfare facility in the city of Sverdlovsk in the former Soviet Union. Some 64 people died, though the incident wasn’t confirmed until the early 1990s.

“With the collapse of the Soviet Union, many research scientists fled to other countries…carrying with them skills for making biological agents and perhaps taking vials of the agents as well,” D.A. Henderson, a leading biodefense expert, said at a public health summit in California earlier this year. “Little is known as to where most of them went, and we know next to nothing about the possible extent of current activities in rogue nations.”

Although manufacturing anthrax bacteria from scratch is considered infeasible at present, “it occurs naturally, and it’s pretty much found worldwide,” Kurilla says, making it relatively easy to capture and manipulate. Grazing animals sometimes pick it up from the ground. “You could probably get it from vet schools.”

Traditionally, people handling contaminated animal tissue or hides—ranchers, butchers, wool processors, as well as veterinarians—have been most at risk. That’s how Emergent BioSolutions first got into the business of manufacturing an anthrax vaccine.

Developed by scientists at Fort Detrick in Frederick County nearly 50 years ago, the vaccine now marketed as BioThrax was manufactured for nearly three decades by the Michigan Department of Public Health to protect workers who processed animal hair. In 1998, a group led by Fuad El-Hibri—the U.S.-educated son of a Lebanese financier—purchased the Lansing-based facility from the state of Michigan. The company launched as BioPort, assuming the name Emergent BioSolutions in 2004, when its headquarters relocated to Rockville. It went public two years later.

El-Hibri had been involved with a British company that teamed with the government of the United Kingdom to manufacture an anthrax vaccine. During the first Gulf War in 1991, amid reports that Saddam Hussein had developed biological and chemical weapons, “there was tremendous interest around the world in that product,” says Abdun-Nabi, who succeeded El-Hibri as Emergent’s CEO at the end of March.

At the time of the 1998 purchase, the anthrax vaccine was a “niche product,” Abdun-Nabi says, “maybe a million doses a year, max.” The Defense Department had begun purchasing it a decade earlier to inoculate personnel in certain regions of the world, but the bulk of the market consisted of industries dealing with animals and their byproducts.

That changed dramatically after 2001.

Three years to the month after 9/11, Emergent signed the first in a series of government contracts that will bring the firm nearly $2.6 billion in revenues in return for providing more than 96 million doses of anthrax vaccine through 2016.

CDC officials refuse to say how much anthrax vaccine is in the agency’s Strategic National Stockpile, located in undisclosed warehouses throughout the U.S. But it’s an open secret in biodefense industry circles that the federal government is seeking to maintain about 75 million doses. The contract with Emergent will come close to meeting that goal, taking into account the 25 percent of the anthrax vaccine stockpile that must be replaced each year because it has expired.

BioThrax involves a five-dose regimen for pre-exposure vaccination and a three-dose regimen in tandem with antibiotics for those exposed to anthrax. So 75 million doses translates into treatment for 15 million to 25 million people. Some call this the “three-city scenario”: enough to cover the populations of the nation’s two largest cities, New York and Los Angeles, as well as the Washington, D.C., metropolitan area. (By contrast, the smallpox vaccine stockpile is sufficient for the entire U.S. population.)

Since taking over the Michigan facility back in 1998, Emergent has come under fire for everything from its technology—which dates to the 1960s and limits its ability to meet increased demand—to the cost of manufacturing.

PharmAthene is banking on a newer, genetically engineered anthrax vaccine using technology formally known as “recombinant protective antigen,” aka rPA. Not only does it result in a purer, more effective vaccine, Richman says, but it can be manufactured more quickly and less expensively.

“If there were an attack or some sort of exposure, the government needs a surge capacity,” he says. “So we’d be waiting for 20 years for Emergent to make enough vaccine for the population of the United States, whereas PharmAthene could provide it in a very short period of time.”

Abdun-Nabi acknowledges that his firm currently can produce only 7 million to 9 million doses of BioThrax annually. But a forthcoming expansion of the firm’s Michigan facility will raise that to 25 million to 50 million, he says, pending approval from federal regulators, which the company hopes to obtain in late 2014.

Richman says his firm would be capable of producing up to 150 million doses a year of SparVax, the vaccine it’s developing. The firm also is “targeting a $15-a-dose” vaccine with a three-dose regimen for preventive purposes vs. $29 per dose for BioThrax and its comparable five-dose regimen.

Abdun-Nabi takes issue with his rival’s math, however. He says most of the national stockpile of anthrax vaccine is being maintained for post-exposure use, and that involves a three-dose, rather than a five-dose, regimen of BioThrax. He also notes that Emergent has increased its vaccine’s shelf life to four years—vs. three at present for SparVax—and hopes to get that to five years to further reduce costs.

“Their $15 ends up being $30 or maybe more as you rotate through the stockpile,” he says.

Emergent currently is working on a competitor for PharmAthene’s rPA vaccine. Not that newer is necessarily better, Abdun-Nabi says. He boasts that BioThrax has an effectiveness rating of “over 90 percent” for both cutaneous and inhalational anthrax. (PharmAthene says its vaccine has shown similar effectiveness in clinical trials.)

“If you look at other vaccines in the world…the polio vaccine was developed in the ’50s, and is still the same product they’re using today,” Abdun-Nabi says. “The tetanus vaccine that you get every 10 years and diphtheria vaccine that your children get [were] developed in the ’20s. These are beautiful technologies, wonderful products. People don’t change them.”

But that view isn’t widely shared.

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