GTC Biotherapeutics (fka GTCB)

[Biowatch]

Trying to Get Ahead of the Herd
Biotech Has Senator's Support to Do Drug Research at USDA Site

http://www.washingtonpost.com/wp-dyn/content/article/2008/01/13/AR2008011302330.html

By Anita Huslin
Washington Post Staff Writer
Monday, January 14, 2008; D01

In the race to build a national defense against chemical and biological weapons, Annapolis-based PharmAthene is putting its money on an unlikely horse.

Or goat, actually, one with unique properties to enable researchers' development of a drug that would foil the neurological effects of chemical weapons. PharmAthene has a herd of 200 of the animals at its research facility in Canada. Now it wants to add another, at the USDA's Beltsville Agricultural Research Center in Prince George's County.

PharmAthene is one of several biotech companies vying to develop drugs under Project Bioshield, the federal government's $5.6 billion initiative to accelerate the creation of drugs and vaccines to combat the effects of biological and chemical weapons. The effort was launched after anthrax attacks in 2001 killed five and sickened dozens.

Because there is no other market for these products besides the government, the expense of developing them can be significant for companies, which often depend on federal grants and congressional appropriations to subsidize their work.

PharmAthene has found an ally in Sen. Benjamin L. Cardin (D-Md.) for its plans to expand its goat herd. A House-Senate conference committee this week could consider a measure Cardin inserted in the federal farm bill that would permit the Beltsville Agricultural Research Center to lease space to a nongovernmental agency.

PharmAthene's development of a drug to neutralize the effects of chemical weapons would stimulate other scientific work at the Beltsville center, according to Cardin.

"We think that PharmAthene and BARC can be great partners together and we are working hard to bring this public-private partnership to fruition," Cardin said.

Using goats it has genetically modified to produce a particular human protein, which PharmAthene harvests from the goats' milk and serves as the foundation for the drug. PharmAthene has spent the past three years formulating the drug, Protexia, that would absorb and detoxify nerve agents before they cause neurological damage. The drug would be given to troops before they go to battle and could be used as a treatment after exposure.

John Troyer, senior program director for PharmAthene's Protexia project, said the company has not received a government contract to produce an initial batch of doses. But the company is working on efficacy studies of the product and has received interest from some foreign governments. PharmAthene needs to expand so it can produce more animals for a number of studies, Troyer said.

A key question is how to neutralize VX nerve gas, for example, which can linger on surfaces for a long time and be picked up if people touch it, Troyer said.

"It can be absorbed into the skin, and they won't know they're sick for hours or even days. So we're looking at how effective is Protexia at treating individuals if they've gotten nerve gas or [chemical] exposure."

Development of drugs like Protexia is part of a three-pronged federal approach to bolstering the nation's strategic stockpile of medicine and medical supplies. Project Bioshield calls for the government to amass vaccines and other preventive remedies, stockpile treatments for people who have been exposed, and produce medicines to combat the natural toxins released by anthrax and other biological agents.

Though the first federal contracts for anti-anthrax therapies went to Rockville's Human Genome Sciences and Canadian firm Cangene, PharmAthene executives said their firm was not far behind in the race to produce drugs to battle chemical weapons and anthrax.

"We absolutely believe in our products, and in our ability to compete and win a contract," said Francesca Cook, vice president of policy and government affairs for PharmAthene. Project Bioshield "is still getting formulated," Cook said, and PharmAthene is moving forward with its research to compete in the next round of federal contracts.

The company is working on a drug called Valortim aimed at counteracting toxins released by anthrax bacteria. Those toxins can build up quickly, killing a victim within days of exposure. The treatment is similar to one being developed by HGS and Elusys Therapeutics of Pine Brook, N.J. The efficacy of the drugs is still being tested, and none has been licensed.

In the effort to develop antitoxins for anthrax, HGS has taken the lead. Last month, the company completed clinical trials that showed its drug, ABthrax, improved survival rates in monkeys infected with anthrax and was safe for human consumption.

"That was the last remaining significant scientific hurdle that we had to overcome," said HGS spokesman Jerry Parrott. "The major task remaining under our contract for delivery to the Strategic National Stockpile is the actual manufacturing of the product."

The firm expects to produce the 20,000 doses the government ordered, with a price tag of $165 million, by the end of this year, Parrott said. The Department of Health and Human Services, which administers Project Bioshield, also awarded Cangene a $144 million contract to produce 10,000 doses of an anthrax antitoxin.

HGS has received some federal support, but has largely paid for its research itself, company officials said. PharmAthene has gone a different route, seeking federal grants and congressional appropriations to subsidize its work. Last week, it learned that it won a $1.6 million earmark in the new defense bill for its Valortim research from Reps. Rush D. Holt (D-N.J.) and Tom Latham (R-Iowa). Over the past several years, PharmAthene has received close to $24 million in federal funding, including $13.9 million to co-develop the drug with Medarex of Princeton, N.J.

Over the past year, PharmAthene has campaigned for resources to develop medical countermeasures against bioterrorism threats.

Last November, it hired a consulting firm to produce a report about the threat to the United States that described various scenarios in which attacks could cause death and panic on the New York subway system, a Minneapolis theater, a Las Vegas casino, California theme park and the Academy Awards in Hollywood.

"After each attack, the facilities are shut down and fear builds in the public," the report said. "Hundreds of FBI agents work to discover the perpetrator without success, not unlike the 2001 attacks in the U.S. There is no end in sight from the attacks."

USDA links:
http://www.washingtonpost.com/ac2/related/topic/U.S.+Department+of+Agriculture?tid=informline