Pharmaceutical firms set for do-over on Anthrax vaccine
The situation is a rematch between reworked solutions presented to HHS years before, when the department first began its complicated search for a second-generation anthrax vaccine.
By Rob Margetta, CQ Staff
WASHINGTON — A pair of Maryland biodefense companies bearing down hard on the Department of Health and Human Services' counteranthrax priorities recently received some good news: their proposals for a second-generation vaccine are contenders to produce 25 million doses for the Strategic National Stockpile.
HHS has told PharmAthene, of Annapolis, and Emergent Biosolutions, of Rockville, that their proposals are technically acceptable and in the competitive range to produce a recombinant protective antigen (rPA) anthrax vaccine, which should produce fewer side effects than current treatment and work in three doses, instead of six. HHS expects to issue an award by the end of the year. The award could go to one contractor or more.
Both companies say they are in negotiations with HHS.
Although the companies are responding to a 2008 solicitation, in a way, the situation is a rematch between reworked solutions presented to HHS years before, when the department first began its complicated search for a second-generation anthrax vaccine.
HHS first sought contractors in 2004, as part of the then-new Project Bioshield, (PL 108-276) a 10-year plan to develop countermeasures to biological weapons and epidemics. For two years, British-based Avecia Biologics and California-based VaxGen had been working on rPA vaccines, with each receiving more than $80 million in HHS money. To Avecia's disappointment, VaxGen received the $877.5 million, 75 million dose award.
But that wasn't the end of the story. After VaxGen missed contract deadlines because of stability issues with its solution, HHS withdrew the contract in December 2006.
Avecia had continued its anthrax research, even without a government contract and, shortly after HHS put out its current 25 million dose solicitation in February, it was bought by PharmAthene. Meanwhile, VaxGen sold the assets for its experimental anthrax vaccine to its competitor, Emergent Biosolutions.
Now, PharmAthene's contender for a second-generation vaccine is SparVax, the solution developed at Avecia, which the company says has successfully completed pre-clinical effectiveness testing on animals and tolerance and immune response testing on more than 700 healthy people during Phase I and Phase II trials.
"Our primary focus with Avecia was really the Anthrax vaccine," PharmAthene Director of Corporate Communications Stacey Jurchison said.
Emergent is calling its proposed solution simply "rPA 102." It's a reformulated and more stable form of a vaccine originally developed at the U.S. Army Medical Research Institute of Infectious Diseases -- which was licensed to VaxGen, then licensed to Emergent, company officials said. The Emergent vaccine has also completed Phase II trials.
"We believe our rPA anthrax vaccine can be successfully developed and . . . can become an important component of out nation's stockpile of medical countermeasures," company Chairman and CEO Fuad El-Hibri said.
PharmAthene and Emergent say they are positioning themselves to fill not only HHS' second-generation vaccine needs, but the department's other anthrax priorities. Both are developing "monoclonal antibodies," which attack anthrax toxins and promise to be more advanced methods of treating and preventing infection.
"We have a pretty strong franchise when it comes to anthrax," said Allen Shofe, senior vice president of public affairs at Emergent.
Shofe's company also touts the fact that it produces the current-generation vaccine for the national stockpile -- the only FDA-licensed product to prevent anthrax infection. The vaccine, BioThrax, is taken in six doses over 18 months.
HHS is procuring 18.75 million doses of BioThrax, and Shofe said that shows a track record of production. If it receives the second-generation contract, Emergent would produce it in the same Lansing, Mich. where it makes BioThrax.
"We have the experience, and the ability to bring this second generation technology to fruition," Shofe said. "We have the experience supplying the stockpile, we have the experience in management, we have experience in managing the stockpile and we have experience in developing medical countermeasures."
PharmAthene officials sounded equally confident.
"The issuance by HHS of a Request for Proposals for next generation anthrax vaccines acknowledges a need for a new anthrax vaccine that offers the potential for improved safety and convenience, and we believe that our product candidate, SparVax, is well positioned to meet the government's requirements," President and CEO David P. Wright said.