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Emergent BioSolutions, Inc.

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FDA Completes Pre-Approval Inspection of Emergent BioSolutions’ Large-Scale Manufacturing Facility for BioThrax

GAITHERSBURG, Md., June 21, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has completed its Pre-Approval Inspection (PAI) of Building 55, the company’s facility for large-scale manufacturing of BioThrax® (Anthrax Vaccine Adsorbed). At the conclusion of the inspection, the company received a No Action Indicated decision and no Form 483 observations. Successful completion of the PAI is one of the requirements for Building 55 licensure in connection with the company's supplemental Biologics License Application (sBLA) recently accepted by the FDA. The sBLA has a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.

“Emergent is pleased to have reached this critical milestone in our BioThrax comparability program. The positive outcome from this pre-approval inspection is a testament to our employees’ tireless efforts, to our substantial financial investment in Building 55, and to our strong partnership with BARDA,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to timely completing the process for securing FDA licensure of our facility.”
The BioThrax comparability program is fully funded at $104 million under contract number HHSO100201000034C 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, 6/21/16. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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FDA Accepts Emergent BioSolutions’ Supplemental Biologics License Application for Large-Scale Manufacturing of BioThrax in Building 55

GAITHERSBURG, Md., June 17, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.
“Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is a response to the U.S. government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to our continued collaboration with the U.S. government to help in its commitment to protect the nation against public health threats such as anthrax.”
The sBLA, submitted on April 15, 2016, is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. BioThrax, the only FDA-licensed anthrax vaccine, is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease.
This program is fully funded at $104 million under contract number HHSO100201000034C 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, 6/17/16. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Emergent BioSolutions Submits sBLA for FDA Approval of Large-Scale Manufacturing of BioThrax in Building 55

GAITHERSBURG, Md., April 18, 2016 (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 approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. The sBLA is supported by data that demonstrate that BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility. This submission follows the company’s successful completion of the re-analysis of data from one of more than 30 comparability assays for BioThrax manufactured in the new facility as requested by FDA.

“Emergent is pleased to have reached this significant milestone in our BioThrax comparability program. Anticipating that a typical FDA review of such a submission is four months, we expect the review process to be completed in the fall of this year,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We believe that our submission conveys the robustness of our large-scale manufacturing process, the comparable product attributes, and the efficacy and consistency of the product from our new facility, supported by a variety of developmental and pivotal nonclinical studies. This milestone reflects many years of steadfast dedication from our project team and their effective collaboration with the U.S. government.”

BioThrax is the only FDA-licensed anthrax vaccine. It is indicated for both pre-exposure and post-exposure prophylaxis of anthrax disease. Since 2001, the company has been supplying BioThrax to the Strategic National Stockpile to support the U.S. government’s biosecurity and preparedness efforts. Building 55 has the potential to expand manufacturing capacity of BioThrax to an estimated 20 to 25 million doses annually from the seven to nine million doses produced annually out of the currently-licensed facility. The capability to manufacture BioThrax at large scale positions the company to meet the government’s desire of stockpiling 75 million doses of a licensed anthrax vaccine.

This program is fully funded at $104 million under contract number HHSO100201000034C 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.
More
Source: press release, 4/18/16. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Daniel J. Abdun-Nabi, President and CEO, gave an update regarding the Buigave guidance for the Building 55 licensure. He stated, "Turning now to Building 55, as we previously announced, the FDA requested that we perform a reanalysis on one of the more than 30 assays used for comparability before filing our sBLA. We are on track to complete their request during the first half of the year, after which we expect to submit the sBLA. As a reminder, we anticipate a PDUFA date of 4 months following acceptance by the FDA of the sBLA filing."
Source: Q4 2014 earnings conference call, 03/05/15.

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Daniel J. Abdun-Nabi, President and CEO, gave guidance for the Building 55 licensure. He stated, "I would like to start with our BioDefense Division and Building 55 which is our large scale BioThrax manufacturing facility. We continue to work on progressing Building 55 to licensure and last month we announced that the primary end points in our pivotal study were met. The study showed that vaccine produced at Building 55 is comparable to that manufacturing Building 12 our currently approved facility. We have sent to summary of key data to the FDA and plan to submit, to meet with them this month to discuss our sBLA filing strategy. The remainder of 2015 will entail completing the final study report, the prior approval inspection of the facility, and the sBLA we continue to work towards the goal of obtaining approval in late 2015 or early 2016."
Source: Q4 2014 earnings conference call, 03/05/15.

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Emergent BioSolutions Announces Primary Endpoints Met in Pivotal Study Supporting Licensure of Building 55

GAITHERSBURG, Md., Feb. 13, 2015 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced completion of the in-life phase of the pivotal nonclinical efficacy study designed to demonstrate that BioThrax® (Anthrax Vaccine Adsorbed) manufactured at large scale in the company's new modern facility, Building 55, is comparable to the BioThrax currently manufactured in its approved facility, Building 12. Interim analysis has shown that the primary endpoints were met; these include demonstrating comparability to vaccine manufactured in Building 12 as well as consistency between lots manufactured in Building 55. Data from this study will be used to support a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for licensure of Building 55. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.

Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, "The Building 55 scale-up program represents years of collaborative effort with BARDA and FDA to meet the U.S. government's stated requirement of 75 million doses in the Strategic National Stockpile. Emergent is pleased with the completion of the in-life phase of our pivotal study. The remainder of 2015 will entail finalizing the nonclinical pivotal study report, progressing efforts related to the Prior Approval Inspection of the Lansing facility, and compiling the sBLA. We are continuing to work with FDA and anticipate approval in either late 2015 or early 2016."

Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually. Both facilities are located on Emergent's Lansing, Michigan campus.
This program is fully funded at $104 million under contract number HHSO100201000034C 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.
More
Source: press release, 2/13/15. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Emergent BioSolutions Initiates Final Pivotal Study to Support Licensure of BioThrax at Large Scale

Large Scale Manufacturing of BioThrax in Building 55 Will Increase Annual Production Capacity from 7-9 Million Doses to a Target of 20-25 Million Doses

ROCKVILLE, Md.--(BUSINESS WIRE)--Sep. 23, 2014-- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of the pivotal non-clinical efficacy study to demonstrate that BioThrax® (Anthrax Vaccine Adsorbed) manufactured at large scale in the company’s new modern facility, Building 55, is comparable to the BioThrax currently manufactured in its approved facility, Building 12. Data from this study will be used to support licensure of Building 55. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of anthrax disease.

Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, stated, “We are pleased to have advanced this Comparability Program through an effective partnership with BARDA. This represents an innovative approach to developing medical countermeasures and meeting the U.S. government’s requirements for an anthrax vaccine. In collaboration with FDA, and after having received concurrence on pre-established study endpoints, we are moving forward with a high degree of confidence in this study. We have completed manufacturing BioThrax lots for use in this fifth and final study required for licensure of the scaled-up manufacture of BioThrax in Building 55. We are targeting a rolling submission to FDA of the supplemental Biologics License Application, including data from Chemistry, Manufacturing and Controls by early next year, followed by data from this pivotal non-clinical study later in 2015.”

The primary objectives of this randomized, observer-blinded study are to demonstrate consistency of three BioThrax vaccine lots manufactured in Building 55 based on lot-to-lot equivalence as well as to demonstrate comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.
Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually. Both facilities are located on Emergent’s Lansing, Michigan campus.

This program is fully funded, up to $107 million, under contract number HHSO100201000034C 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, 9/23/14. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Emergent BioSolutions and FDA Finalize Comparability Protocols Enabling Manufacturing of BioThrax Consistency Lots in Building 55

ROCKVILLE, Md.--(BUSINESS WIRE)--Apr. 22, 2014-- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has initiated manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by the U.S. Food and Drug Administration (FDA) of the Manufacturing and Non-Clinical Study Protocols submitted by the company supporting the Building 55 comparability program. The goal of the comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to the BioThrax currently manufactured in the approved facility, Building 12. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease.
More
Source: press release, 4/22/14. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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Daniel J. Abdun-Nabi, President and CEO, commented on the progress being made for the Building 55 licensure. He stated, "Next, let me provide an update on our progress to secure licensure of Building 55 for the large scale manufacturing of BioThrax. We have completed our data package in response to the FDAs comments on our proposed comparability profile and analysis. Due to the government shutdown our submission of that data package through the FDA was delayed, but is now complete. We are now coordinating with the FDA on a meeting date to address the analysis and we expect that meeting to occur later this year. We continue to plan
for sBLA approval of Building 55 in late 2015."
Source: Q3 2013 earnings conference call, 11/09/13.

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Daniel J. Abdun-Nabi, President and CEO, commented on the progress being made for the Building 55 licensing. He stated, "Finally, let me provide an update on our progress to secure licensure of Building 55 for large scale manufacturing. As has been discussed in the past, we reached agreement with the FDA on our comparability acceptance criteria and the endpoints of our non-clinical study. Based on that understanding in Q2 we submitted to the FDA a comprehensive data package related to product manufacture in B-55 to be used with the non-clinical study. That data package included among other things our proposed selection of key proteins present in BioThrax that we believe demonstrate comparability between material produced in buildings 12 and 55. We recently received the FDA’s feedback on the comparability profile. Specifically, they requested that we expand the number of proteins to be used to establish comparability. We expect to address this request directly with the FDA in the next 60 days and in the meantime we have initiated the additional analytical response to FDA’s request. Currently we anticipate completing both the comparability analysis and the non-clinical study in 2014 and submitting our supplemental BLA filing in late 2014 or early 2015 with FDA approval in due course thereafter. We will keep you apprised of our progress with FDA as we continue to move ever closer to this important milestone for the company."
Source: Q2 2013 earnings conference call, 8/05/13.

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Daniel J. Abdun-Nabi, President and CEO, commented on the progress being made for the Building 55 licensing. He stated, "We also continue to advance the program for large-scale manufacturing of BioThrax in Building 55. Specifically after having successfully completed the pilot non-clinical studies this quarter, we received written confirmation from the FDA that the design of our pivotal non-clinical study is acceptable. This is a very important step towards licensure of Building 55 and we remain on track to submit our sBLA filing to the FDA in 2014 with regulatory approval possibly in late 2014 or early 2015. Timing of both the filing and approval of course is dependent on the interactions and feedback with FDA among other factors."
Source: Q1 2013 earnings conference call, 5/02/13.

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: Non-clinical

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-08-15

Results:

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Emergent BioSolutions Receives FDA Approval for Large-Scale Manufacturing of BioThrax in Building 55
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GAITHERSBURG, Md., Aug. 15, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility located in its 12.5-acre campus in Lansing, Michigan.
“FDA approval of Building 55 is the culmination of more than a decade of investment and collaboration by Emergent and the U.S. government towards the ability to manufacture anthrax vaccines at large scale to protect the nation,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “This milestone represents the U.S. government’s continued commitment to anthrax preparedness and its belief in the company’s core competency in manufacturing and the potential of this facility. The expanded capacity of Building 55 also positions the company to potentially supply anthrax vaccines to allied governments in support of their preparedness plans.”
This program was executed under contract HHSO100201000034C, valued at $104 million, with 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.
More
Source: press release, 8/15/16. http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-...

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