Troops' blood helps Canadian firm develop anthrax drug

No one knows whether a serum being developed by a Canadian drugmaker will help victims of anthrax exposure.

But under a contract signed in the wake of 2001 anthrax attacks that killed five people, the U.S. Department of Health and Human Services is paying the company more than $14,000 per dose of its anthrax immune globulin -- which is years away from licensure.

To develop the serum, Winnipeg-based Cangene Corp. is relying on plasma donated by members of the U.S. military who have been vaccinated for anthrax and carry crucial antibodies.

Cangene is having a banner year.

Its revenues for the third quarter of fiscal 2008 were up 30 percent from the same period a year earlier. In a recent statement, the company attributed its growth to the "delivery of a small quantity of Anthrax Immune Globulin" to the U.S. government.

"There's no one that can say it's not expensive," said Robin Robinson, director of Health and Human Services' Biomedical Advanced Research Development Authority. "Because there is not a product line and not an industrial base, (the globulin) takes quite a bit of money to develop."

Robinson noted much of the contract with Cangene is paying for original research. In the future, with competition from other companies, the per-dose cost will drop, he predicted.

Cangene won't reveal how many doses can be made with a single plasma donation, saying it varies by a donor's level of antibodies -- and that is information that could help potential competitors.

Bill Bees, Cangene's senior vice president of operations, said his company's significant investment demands significant compensation.

"It's really a huge investment in terms of doing all the research and development, the work on developing the animal studies, doing the work of analyzing that data and putting it into a package for licensure," Bees said.

All that work, he noted, goes to create a product that, hopefully, will have "a very focused market . . .probably not more than one patient a year."

Indeed, only one man has ever received Cangene's globulin. The patient contracted anthrax while working with animal hides that he had collected on a trip to Africa in late 2005. The man, a drummer with an African dance troupe, recovered after he was given the globulin and other treatment.

"They used our product to save his life," Bees said.

A report on the case in the University of Chicago journal Clinical Infectious Diseases was less certain. It concluded Cangene's globulin "may provide clinical benefit" under the right conditions, but said further study was needed.

But further study can be difficult.

"We're not going to give people inhalation anthrax in order to test the safety," said Alan Marion, principal researcher in a study of the serum's effect on healthy people.

But Marion said the Cangene product is likely to help because it is not unlike many other globulins already on the market for diseases like hepatitis, rabies and tetanus.

Meryle Nass, an outspoken critic of the U.S. government's various anti-anthrax efforts, said she supports the idea of the anthrax immune globulin -- in principle. She noted China has used a globulin created with antibodies from anthrax-infected horses for decades.

But Nass has reservations about the Cangene program.

"At best, it will only afford protection against what the vaccine may protect against," said Nass, who runs the Web site anthraxvaccine.org.

And she is critical of the effectiveness of the Biothrax-brand vaccine used by the U.S. military. When 22 people developed infections in the 2001 attacks, she said, the "Biothrax vaccine protected poorly against multiple different anthrax strains."

Government officials and the company expressed confidence that the anthrax globulin will be fully licensed -- although Cangene isn't expected to file a final Biologic License Application to the U.S. Food and Drug Administration until 2011.

And even if the FDA rejects its product, its contract requires the U.S. government to pay 100 percent of its development costs and 93 percent of the agreed-upon price for each delivered dose.

Cangene has taken in more than $25 million in payments for its product. Under its contract with the government through 2009, it stands to collect more than $144 million.

Iraq war veteran Ryan Poland -- who has had five rounds of anthrax vaccinations -- was between jobs when he learned of the plasma program from a friend, who heard a radio ad.

He was surprised to learn how much Cangene is making for the serum it will develop from his donation, and he suggested the company should "spread the wealth."

After a booster shot and a weeks-long wait for his anthrax antibodies to develop, Poland will make about $600 for an eight-round series of donations.

But he'll take what's offered.

"With a wife and a daughter and a mortgage," Poland said, "I'm always looking for opportunities to get a little extra cash."

E-mail Matthew D. LaPlante at mlaplante(at)sltrib.com

(Distributed by Scripps Howard News Service, www.scrippsnews.com.)