Hollister-Stier (Spokane) to help produce new anthrax vaccine-Local lab under contract to fill vials of test product

The Spokane biotech company that is helping to supply the federal government with anthrax vaccine has won a second contract to produce a safer version.

Tom Sowa
Staff writer Spokesman Review

Hollister-Stier Laboratories was hired by San Francisco drug firm VaxGen to fill vials of a test anthrax vaccine requested by the federal government.

Hollister-Stier is already earning about $1 million annually by filling vials with the only approved anthrax vaccine produced in the United States.

The VaxGen contract will have no impact on Hollister-Stier’s current work or staffing levels.

In October, federal officials awarded VaxGen a $13million contract to develop a test anthrax vaccine that could replace the older product.

VaxGen is the company that last week reported disappointing test results of its experimental AIDS vaccine. Hollister-Stier has no role in the AIDS tests.

But Hollister-Stier is the only U.S. company handling production of two anthrax vaccines, company CEO Anthony Bonanzino said.

"It’s a relatively small development and supply contract now," Bonanzino said. "But it has the potential to be a very large arrangement if test results are positive."

VaxGen ships the components for the test vaccine to Hollister-Stier. The Spokane company mixes those materials — called compounding — into correct proportions and then decants the vaccine in sterilized glass vials. Hollister-Stier then ships the vials back to VaxGen in sealed containers. It is the same process Hollister-Stier uses to fill vials of the original vaccine, which it sends back to Michigan-based BioPort Inc.

The first tests of the new vaccine will occur later this year on monkeys. VaxGen officials did not say where those tests are being conducted.

VaxGen spokesman Jim Key said he wasn’t free to disclose how much the company is paying Hollister-Stier for handling the test vaccine.

If trials of the vaccine prove successful, VaxGen stands to gain a second round of funding for further tests. In that case, Hollister-Stier will likely handle a larger volume of the product and may need more workers.

The urgency behind producing both the "older" vaccine and the modern substitute is driven by government efforts to protect citizens and troops from exposure to the anthrax bacteria.

At the same time that VaxGen is developing its test version of the new vaccine, a second company in England is producing an alternate version using a different formula.

Whichever version proves most effective will likely replace the older anthrax vaccine that was developed more than 30 years ago. The older vaccine has been linked to health issues among U.S. troops.

Spores of anthrax bacillus bacteria, when ingested or absorbed through the skin, can lead to severe respiratory complications or death.

Two years ago, five U.S. residents died after being exposed to anthrax sent through the mail.

The current anthrax vaccine, called BioThrax, requires six injections over 18 months.

BioPort Inc. has the sole contract to develop the BioThrax vaccine. BioPort hired Hollister-Stier in December 2000 to fill vials. BioPort delivers those vials entirely to the federal government.

"We’re very pleased to be working with VaxGen, a very good company," Bonanzino said.

He said VaxGen contacted him more than six months ago about the new vaccine project. The prime reason VaxGen chose Hollister-Stier wasn’t the other anthrax contract, Bonanzino said.

"It was the continuing manufacturing work we’ve taken on, plus our ability to perform on short notice," he said.

It’s uncertain what role Hollister-Stier would play if VaxGen is eventually hired to produce a final version of the new vaccine.

The government has said it plans to order up to 25 million doses when a product has passed all testing.

Hollister-Stier, already operating at maximum capacity, could not handle that much work, Bonanzino has said.

VaxGen officials also have begun developing their own production facility in California. But it’s not certain VaxGen would manage the entire production, company officials have said.

It’s also possible the new contract for 25 million doses would spell the end for the BioThrax contract, Bonanzino said.

That wouldn’t have a detrimental impact if it happened. Hollister-Stier has acquired contracts with more than 20 companies, Bonanzino said. Five years ago it did virtually no contact manufacturing for drug firms. Today that’s by far the company’s fastest-growing area of business, Bonanzino said.

http://www.spokesmanreview.com/news-story.asp?date=030103&ID=s1310959&cat=section.business