Emergent BioSolutions reacts to BARDA's Request for Proposal cancellation

by Nick Rees on December 8, 2009

Fuad El-Hibri

The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA's Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office's Broad Agency Announcement.

BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.

An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.

Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.

This announcement also does not impact Emergent's $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.

“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.

“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost," Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. "BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”

BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent's new 50,000-square-foot Lansing, Mich., manufacturing facility.

"I am proud that Lansing remains home to America's first line of defense against what experts say is the single biggest bioterror threat, anthrax," U.S. Rep. Mike Rogers, MI-08, said. "The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.

"Rest assured, I will continue working to strengthen our nation's existing bioterror preparedness measures and protect national security jobs in Lansing."

Emergent looks to buy Maryland lab

Emergent BioSolutions Inc. hopes to ramp up production of its anthrax vaccine in Lansing.

The Rockville, Md.-based company said Thursday it plans to sell two unused buildings and purchase a manufacturing facility and laboratory in Maryland.

The pending moves could free up space in Lansing for additional production of BioThrax, the only federally approved anthrax vaccine.

"From a strategic perspective, the new Maryland manufacturing facility broadens our options," CEO Fuad El-Hibri said. Terms of the deals were not disclosed.

Nearly 400 employees work for Emergent in Lansing. About 30 have been hired since the company announced plans to add up to 93 new hires as part of an expansion announced in March that included state tax incentives.

Emergent hopes to ramp up the nation's stockpile of doses for use in case of a biological terrorist attack.

"The government has previously stated they want a stockpile of at least 75 million doses. Our calculations would show the stockpile is way short of that," Chief Financial Officer Don Elsey said.

He wouldn't provide details on the stockpile's shortfall, but said the Department of Defense also draws from the supply.

Emergent currently makes the anthrax vaccine in a Lansing facility with a capacity for roughly 7 million doses a year, Elsey said.

In September, the company will start producing 14.5 million doses as part of a $405 million government contract for the national drug stockpile. It will take two years to complete the contract.

A new $75 million large-scale manufacturing plant in Lansing could handle an additional 30 million doses a year.

The building, completed last year, originally was slated to produce the next-generation anthrax vaccine once it received government approval. But Emergent now is proposing production of the new vaccine be moved to the new Maryland facility, allowing Lansing to make more BioThrax - something that also needs a government OK.

"We have shared with the government our thoughts on this and the new capabilities that this will bring and they are considering it," Elsey said. "It's definitely not something that's firm yet."