Human Genome expects $165 million in revenues through ABthrax contract with U.S. government

By Jennifer Lanning Drey

Eugene, Ore., June 20 - Human Genome Sciences, Inc. expects to receive $165 million in revenues through the sale of 20,000 treatment courses of ABthrax (raxibacumab) to the U.S. government in 2008, according to H. Thomas Watkins, president and chief executive officer of the company.

The company will receive 90% of the money upon delivery of the product, which will represent Human Genome's first product sale, Watkins said in a company conference call on Tuesday.

The U.S. Department of Health and Human Services purchased the doses for its Strategic National Stockpile.

"From a strategic perspective, our success in securing this order for ABthrax is one more important step in the transformation of HGS from primarily a discovery company into a development and commercialization company," Watkins said.

Human Genome also said Tuesday that its primary focus will remain on its lead product candidates, Albuferon (albumin-interferon alpha 2b) for chronic hepatitis C, and LymphoStat-B (belimumab) for lupus. Both drug candidates are expected to start phase 3 clinical trials before the end of the year.

"We will continue our primary focus on Albuferon and LymphoStat-B for lupus, but we are very pleased with what the ABthrax contract award means to our company's progress," Watkins said.

ABthrax is a human monoclonal antibody that has demonstrated preventive and therapeutic efficacy for inhalational anthrax in relevant animal models. The drug has also demonstrated safety and tolerability in phase 1 clinical trials with healthy adults.

ABthrax will be manufactured at a 130,000 square foot facility that Human Genome has operated since 1999. ABthrax is the fifth monoclonal antibody to be scaled up in the facility, Watkins said.

"HGS has all of the manufacturing, research and development and other resources that we need to fulfill the terms of the contract and to deliver ABthrax to the National Stockpile," he said.

Human Genome plans to complete additional laboratory and clinical testing to support the filing of a Biologics License Application with the Food and Drug Administration. The additional testing would also support the use of ABthrax in patients with inhalational anthrax disease in the event of an emergency prior to FDA license.

"Now that the U.S. government has agreed to purchase ABthrax, we're ready to move ahead with the additional steps that will be required for its development," said Dr. David Stump, executive vice president of drug development at Human Genome, during the conference call.

The company expects to meet with regulatory authorities to confirm its plans for conducting additional safety trials, which the company said would involve several hundred healthy volunteers. During the studies, the company plans to investigate how ABthrax interacts with antibiotics and vaccines.

The company also plans to conduct efficacy studies with survival and endpoints in relevant animal models to look at interactions with antibiotics and vaccines.

"We expect to complete these studies well within the timeline as required by the contract," said Stump.

Rockville, Md.-based Human Genome develops drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

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