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Emergent BioSolutions, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Daniel J. Abdun-Nabi, President and CEO, commented on the sBLA for BioThrax PEP. He stated, "We have also made progress towards securing a post-exposure-prophylaxis or pep indication for BioThrax. Last November we submitted our application to the FDA for this indication which included data from a dozen non-clinical studies as well as three clinical trials. This label expansion will further support BioThrax’s position as the leading medical counter measure against Anthrax disease. The application is currently under review and we expect the decision to be made sometime in the second half of this year."
Source: Q4 2014 earnings conference call, 03/05/15.

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Emergent BioSolutions Seeks Expanded BioThrax Label; Submits FDA Application for Post-Exposure Prophylaxis

ROCKVILLE, Md., Nov. 10, 2014 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the label of BioThrax® (Anthrax Vaccine Adsorbed) to include a post-exposure prophylaxis (PEP) indication. BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication only.

"This sBLA submission reflects years of collaboration between Emergent and the U.S. government to enhance the country's preparedness to meet immediate public health needs in the event of an anthrax attack. To date, these efforts have led to an enhanced route of administration, a streamlined vaccination schedule and an extended shelf life for BioThrax. The next milestones for this collaboration are an expanded product label to include PEP and an increase in our manufacturing capacity to a target of between 20-25 million doses per year," said Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions.

The company made a Request for Priority Review Designation to potentially reduce the anticipated approval of this application to six months. The sBLA proposes to expand the BioThrax indication to include a post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age. The vaccination schedule consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure. This indication is supported by data from twelve non-clinical studies, three Phase 2/3 clinical trials, and a 2010 pre-Phase 3 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting during which the regulatory pathway for licensure of anthrax vaccines for PEP was established.

All studies supporting licensure were fully funded under contract number HHSO100200700037C provided by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
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Source: press release, 11/10/14. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
BioThrax Infectious DiseaseAnthrax Post-Exposure-ProphylaxisVaccine therapeuticAnthrax antigen

Mechanism of action: BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2015-07-10

Results:

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FDA Approves Emergent BioSolutions' BioThrax for Post-Exposure Prophylaxis

GAITHERSBURG, Md., Nov. 24, 2015 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) approved its supplemental Biologics License Application to expand the label of BioThrax® (Anthrax Vaccine Adsorbed) to include post-exposure prophylaxis (PEP) of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended antibacterial drugs. The vaccination schedule for this new indication consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure combined with antimicrobial therapy. BioThrax is the only FDA-licensed vaccine to prevent anthrax.
“Our BioThrax enhancement program is evidence of our successful partnership with the U.S. government to support the nation’s biosecurity efforts. Over the years, we have enhanced the features of BioThrax to include intra-muscular route of administration, a streamlined vaccination schedule, extended shelf life, and now a post-exposure prophylaxis indication. We are proud of these achievements and look forward to continuing to supply the stockpile with this important medical countermeasure,” said Adam Havey, Executive Vice President and President, Biodefense Division at Emergent BioSolutions.
This expanded indication is supported by data from non-clinical studies, three clinical trials, and a 2010 pre-Phase 3 Vaccines and Related Biological Products Advisory Committee meeting, which confirmed the regulatory pathway for licensure of anthrax vaccines for PEP. BioThrax is the only vaccine to be licensed for post-exposure prophylaxis against anthrax, and is the first vaccine to be licensed using the FDA Animal Rule.
Licensure of BioThrax for PEP is the culmination of a 10-year collaborative effort between Emergent, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases. Studies supporting licensure were funded in part under contract number HHSO-100-2007-00037C provided by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
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Source: press release, 11/25/15. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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