Human Genome starts shipping new anthrax drug

Human Genome Sciences Inc. said on Monday it was beginning delivery of 20,000 doses of ABthrax, which fights anthrax infection, to the U.S. government.

It is the first sale for the biotechnology company, which has struggled to get a product onto the market.

The drug takes a new approach to fighting bacterial infection by targeting the toxin made by the anthrax bacillus instead of the microbe itself.

ABthrax, known generically as raxibacumab, is a human monoclonal antibody—a lab-engineered immune system protein. This one is designed to attack and neutralize the toxic compound that makes anthrax so deadly.

The U.S. government contracted with the Maryland-based biotech firm to make the drug in case of a biological attack under Project BioShield, the company said.

Anthrax is a fairly common bacterium and usually causes an easily treated skin lesion. But if inhaled, it can take hold quickly and by the time a person starts showing symptoms, it is usually too late for successful treatment with antibiotics.

This is because the bacteria pump out toxins that are not affected by antibiotics and that persist after the bacteria are dead.

There is an anthrax vaccine but it must be given before exposure.

LETTER ATTACKS

In October 2001, soon after the September 11 attacks, letters carrying powdered anthrax killed five people and sickened 13 more. Federal investigators have blamed Dr. Bruce Ivins, an anthrax vaccine researcher at Fort Detrick in Maryland.

Ivins killed himself last year before he could be charged.

Bioterrorism experts say anthrax is a very likely weapon of choice for future attacks.

“In contrast to the anthrax vaccine, the protection afforded by a single dose of ABthrax would be immediate following the rapid achievement of appropriate blood levels of the medication, making it potentially useful for ‘first responders’ and members of the military,” the company said in a statement.

Animal studies have shown Abthrax provides 100 percent protection if given before inhaling anthrax. One dose after exposure improves an animal’s survival odds by 64 percent.

The U.S. Food and Drug Administration, which has not yet licensed the drug, accepts data from two animals in lieu of human tests for certain deadly infections.

“HGS has also completed safety studies of ABthrax in more than 400 human volunteers. The clinical results to date suggest that ABthrax was generally safe and well tolerated,” the company said.

“We believe ABthrax offers a significant step forward in the treatment of inhalation anthrax and could play an important role in strengthening America’s arsenal against bioterrorism,” said H. Thomas Watkins, president and chief executive officer of Human Genome Sciences.

“From a business perspective, this announcement is strategically important for HGS, because it marks our company’s first product sales.

HGS expects $165 million in revenues from the award, with $150 million in the first half of 2009, following delivery of 20,000 doses of ABthrax, and the rest when the FDA licenses it.

The company is also working to license Albuferon for patients with hepatitis C and LymphoStat-B for lupus, as well as cancer drugs.

By Maggie Fox
WASHINGTON (Reuters)