Human Genome clears hurdle

Anthrax drug improves survival rate in animals

December 19, 2007|By Dennis O'Brien | Dennis O'Brien,Sun reporter

A Rockville biotech company announced yesterday that it has cleared a major hurdle in fulfilling a $165.2 million federal contract to supply a new anthrax drug.

Human Genome Sciences Inc. says its clinical trials show that a single dose of ABthrax improved survival rates up to 64 percent in monkeys infected with anthrax over a 28-day period. The drug also proved safe in trials where it was given to 180 human volunteers.

"The most challenging scientific work is behind us," Dr. David C. Stump, a physician who is executive vice president, told reporters in a telephone briefing yesterday.

Administering ABthrax in combination with the antibiotic Cipro did not inhibit the effectiveness of either drug, company officials said. Using the drug with Cipro should increase its effectiveness beyond the 64 percent survival rate observed in primates, company officials said.

They also reported "statistically significant" improvements in survival rates of infected rabbits, but declined to release specifics of those trials. To meet federal requirements, the drug has to improve survival rates in two species of animals.

"This is exactly what is required to establish the efficacy of new drugs to counter bioterrorism," Stump said.

In June 2006, Human Genome won a $165.2 million contract from the Department of Health and Human Services to supply 20,000 doses of ABthrax to the nation's Strategic National Stockpile of the emergency medications.

The company, which employs 850, is also in late-stage clinical trials of two drugs: Albuferon for hepatitis C, and LymphoStat B for lupus.

Delivery on the ABthrax contract is a major step for the 15-year-old firm because the drug is the company's first product to generate sales revenue, said Edward Tenthoff, an analyst with Piper Jaffray & Co. in New York.

"This is an important milestone for the company," said Tenthoff, who does not own Human Genome stock or work for firms that have investment relationships with the company.

The company's stock rose 44 cents yesterday to close at $10.98 on the Nasdaq exchange.

Delivery of the product - along with the federal payments on the contract - is expected to begin in late 2008, said H. Thomas Watkins, the company's president and chief executive officer.

Winning approval to supply the drug for national emergencies is a first step, company officials said. Additional human clinical trials, necessary for federal approvals before it can be sold as a commercial product, are continuing, Watkins said.

The company also hopes to sell the drug to other countries.

Anthrax treatments approved by the Food and Drug Administration are currently limited to vaccines, which prevent infection, and antibiotics such as Cipro that treat victims once they're infected.

But vaccines take weeks to produce immunity and require multiple injections.

Antibiotics can kill the anthrax bacteria, Bacillus anthracites, but can't counteract the deadly toxins those bacteria turn loose in the bloodstream. ABthrax is designed to disarm those toxins.

Anthrax killed five Americans a few weeks after the Sept. 11, 2001, terrorist attacks, sparking panic about the safety of opening mailed packages and even more worries about airline travel. Inhaling the spore-form- ing bacterium can be fatal.

President Bush signed Project BioShield into law in 2004, providing funding for new anthrax medications. Since then, federal money has flowed to a number of biotechnology firms.

VaxGen Inc., a California firm, won an $876 million contract to supply 75 million doses of anthrax vaccine in 2004 and BioPort Corp., a Michigan firm, won a $122.7 million contract for five million doses of vaccine in 2005.

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