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Emergent Supplies 1M BioThrax Doses While HHS Reworks Plans

Emergent Supplies 1M BioThrax Doses While HHS Reworks Plans
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By Aaron Lorenzo
Washington Editor

The strategic national stockpile has received nearly another million anthrax vaccine doses by way of an early delivery from Emergent BioSolutions Inc., a company clearly positioning itself to further fulfill the government's needs going forward.

The biopharmaceutical firm, of Rockville, Md., now has provided 10 million doses to the nation's supply. Its product, BioThrax (anthrax vaccine adsorbed, or AVA), is the only FDA-approved anthrax vaccine. It was first licensed in 1970.

"We manufacture BioThrax 24 hours a day, seven days a week," said Robert Burrows, Emergent's vice president of corporate communications. "It's about efficiencies, and this is what we do. We're the only producer, and we're ready to provide product when and where necessary."

Emergent received $22 million for this delivery, and Burrows told BioWorld Today that the company is "absolutely" working to sell more to the Department of Health and Human Services (HHS), which is coordinating procurement efforts for the stockpile in the event of another civilian attack with anthrax. The company has supplied BioThrax through two 5 million-dose orders from the department, which is buying it for off-label, postexposure use under an emergency use authorization.

Over the past couple of years, HHS had been aiming to acquire a previously stated, top-end goal of 75 million total anthrax vaccine doses, but now is backing off that projection and instead is reworking plans on how much to accumulate.

"The number of doses that we will buy for the stockpile is currently under review," spokesman Marc Wolfson told BioWorld Today, noting that HHS officials "are still looking at that whole process and how many doses they're going to buy at this point."

The bulk was expected to be in the form of a so-called second-generation product, for which Brisbane, Calif.-based VaxGen Inc. had received an $877.5 million order more than two years ago for its recombinant protective antigen (rPA) vaccine. But at the end of last year, HHS dissolved that arrangement following stability setbacks with the product. (See BioWorld Today, Dec. 21, 2006.)

And while Wolfson said the department "is still committed to procuring a second-generation" vaccine, HHS has yet to issue any official orders for another anthrax vaccine of any sort. "Ultimately this is all going to be revealed," he said, "but they're not ready to announce it yet."

Burrows said Emergent's work to improve BioThrax could fulfill the department's desire for a second-generation product, one with a better profile in terms of a shorter course of treatment. At present, the vaccine is delivered through three initial doses within four weeks, followed by three additional administrations at six, 12 and 18 months. In collaboration with the Centers for Disease Control and Prevention, the company is developing a newer version that cuts the number of doses in half and has a three-year shelf life.

"We're not resting on our laurels," Burrows said. "We're continuing to progress and enhance BioThrax to become a better product than it already is."

Another company developing a second-generation anthrax vaccine, Avecia Biotechnology Inc., of Milford, Mass., is working on the rPA route.

Both companies were among several caught by surprise last week when HHS canceled a request for bids to produce a third-generation anthrax vaccine, a process that was being run by the National Institute of Allergy and Infectious Diseases. Wolfson, who said the decision followed a peer-reviewed procedure, added that NIAID isn't walking away from its goal, but instead is conceding that none of the current proposals was the right fit.

"The proposed candidates weren't sufficiently mature to meet the milestones that were required," he said, "so they decided it would be premature to make an award at this time because it could actually undermine long-term efforts to obtain a third-generation vaccine."
Such a product was expected to have enhanced characteristics with room temperature storage and an extended shelf life, and make use of new adjuvants and delivery systems, essentially providing a tool for mass immunization. Emergent's efforts in that area make use of an adjuvant from Coley Pharmaceutical Group Inc., of Wellesley, Mass., and their partnered work is moving forward.

"If HHS remains committed to some next-generation [anthrax vaccine], or equivalent thereof," Burrows said, "we're confident that the product we currently have as well as its enhanced version will have a very good potential to be a participant in whatever procurement contract comes from that."

The company, which was previously known as BioPort Corp., also sells BioThrax to the Department of Defense for military use. The Pentagon has bought more than 8 million doses to date, and is committed to purchase another 11 million doses in the next five years. In addition, Burrows said the Defense Department's plan to resume mandatory vaccinations in certain high-threat areas represent "a nice opportunity" to supply more BioThrax.

The company also is looking to expand the product's market internationally to include friendly governments, as well as for first-response use within domestic local governments. In addition, the company is working to expand BioThrax's label to include postexposure prophylaxis when used in conjunction with antibiotics.

Beyond anthrax vaccines, HHS also has contracted to purchase anthrax therapeutics for the stockpile. Rockville-based Human Genome Sciences Inc. has an order for 20,000 treatment courses of its monoclonal antibody ABthrax, and Cangene Corp., of Winnipeg, Manitoba, is to produce 10,000 doses of anthrax immune globulin.

There is speculation that HHS' continued silence on plans for further vaccine procurements is a signal that more therapeutic contracts are on tap - certainly a number of companies are waiting in the wings - but Wolfson said such talk remains conjecture ahead of HHS' intention to unveil a broad implementation plan that will include public guidance on various biological, chemical and radiological threats. It could be released just before a stakeholders' meeting being scheduled for the middle of the year.

"When it's laid out there," he said, "you'll see exactly what they're going to be looking for in terms of therapeutics, vaccines and all the other stuff they're going to buy."

In addition to BioThrax, Emergent is developing a few other biodefense products: an anthrax immune globulin, a botulinum vaccine and a botulinum immune globulin. On Friday, its stock (NYSE:EBS) traded down 4 cents to close at $14.02, following a sharper drop earlier in the week after the third-generation anthrax vaccine news broke.

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