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Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO Parliamentarians

Tuesday, July 13th, 2010

ROCKVILLE, Md., Jul 12, 2010 (BUSINESS WIRE) –

Emergent BioSolutions Inc. (NYSE:EBS) is hosting “Bioterrorism Prevention, Preparedness and Response,” a forum organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA) to raise global awareness of the importance of biopreparedness. The visiting delegation is composed of parliamentarians from Canada, Estonia, France, Finland, Germany, Greece, Italy, Hungary, Lithuania, the Netherlands, Norway, Romania, Poland, Portugal, Turkey, Sweden, Slovenia, Spain, and the United Kingdom.

“Emergent commends NATO parliamentarians for advancing the international dialogue on biopreparedness,” said Allen Shofe, senior vice president public affairs, Emergent BioSolutions. “We are pleased to share our knowledge based on Emergent’s extensive experience in the development, manufacture, and delivery of medical countermeasures that are critical to the U.S. government’s biodefense infrastructure.”

The forum features biodefense expert Dr. Robert Kadlec, Director of PRTM Biodefense and Public Health Practice, who will discuss the United States’ approach to bioterrorism prevention, including best practices and strategies such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

Emergent BioSolutions’ senior management team, headed by Daniel J. Abdun-Nabi, President and Chief Operating Officer, Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services, and Dr. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) are among the attendees. The forum is taking place in Washington, D.C.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About the NATO Parliamentary Assembly

The NATO Parliamentary Assembly is the inter-parliamentary organization of legislators from the member countries of the North Atlantic Alliance as well as 14 associate members. The Assembly provides a critical forum for international parliamentary dialogue on an array of security, political and economic matters. For more information, visit www.nato-pa.int.

Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

Friday, December 11th, 2009

by Nick Rees on December 8, 2009

El-hibri_fuad

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.”

Cornerstone Ceremony Welcomes New Vaccine Production Facility To Michigan

Monday, August 3rd, 2009

Emergent BioSolutions’ $75 Million Investment and Commitment to Michigan Applauded by Governor Granholm.

LANSING, MI, July 21, 2006 – Emergent BioSolutions, a biopharmaceutical company, announced today the dedication of a new large-scale vaccine production facility for its BioDefense Operations in a gala ceremony on itsLansing, Michigan campus. This $75 million dollar project represents a significant investment in the company’s future and adds biotechnology diversity to Michigan’s economy.

Governor Jennifer Granholm and other dignitaries and visitors, including Lansing Mayor Virgil Bernero and Major General Stephen Reeves (Executive Officer, Department of Defense Joint Program for Chemical and Biological Defense), were on hand for the cornerstone ceremony.
“This building represents a major investment in our biodefense business, and significantly expands our core manufacturing capabilities,” said Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions. “When we purchased this facility from the state in 1998, we could only dream of being where we are today. With the support of our employees, our customers, the city of Lansing, and the state of Michigan, that dream is now a reality.”

The new 50,000-square-foot facility is designed to enable the company to expand production of its current product, BioThrax (Anthrax Vaccine Adsorbed), and will provide the potential opportunity for production of other products in the company’s pipeline. Construction of this facility began in February 2006 and is scheduled for completion in 2007. The company expects to initiate manufacturing in this new facility in 2008. BioThrax is the only FDA-approved anthrax vaccine. Present customers include the U.S. Department of Health and Human Services, the U.S. Department of Defense, and certain foreign governments.

“This historic Lansing site has seen a number of milestone events in its long history, and we’re proud to call Michigan home,” said Robert G. Kramer, President of BioDefense Operations for Emergent Solutions. “This project signifies our unwavering commitment to protecting life. This facility is designed to provide new and expanded capabilities to produce immunobiotics to defend against biological agents and other public health threats.”

About Emergent BioSolutions
Emergent BioSolutions is a biopharmaceutical company dedicated to protecting life through the development, manufacture, and commercialization of immunobioticsTM, which are novel products that direct the immune system to prevent and treat life-threatening diseases. These include products for prophylactic and therapeutic use against serious diseases where there exists significant unmet or underserved medical needs and against biological agents which may potentially be used as weapons of bioterrorism. The company currently employs more than 450 people with sites in Maryland, Michigan, the United Kingdom, Germany, and the Republic ofSingapore. More information about Emergent BioSolutions is available at www.emergentbiosolutions.com.

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Emergent Biosolutions Anticipates 2Nd Quarter Biothrax Revenues Of Approximately $20 Million Based On Accelerated Delivery To Department Of Defense

Tuesday, June 30th, 2009

Company preparing response to DoD request for proposal for delivery of up to 14 million additional doses of BioThrax

ROCKVILLE, MD, June 27, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today that, pursuant to the terms of an amended contract with the U.S. Department of Defense (DoD), it anticipates completing delivery of 900,000 doses of BioThrax® (Anthrax Vaccine Adsorbed) during the quarter ending June 30, 2007 or shortly thereafter.  The company anticipates that, with these deliveries, second quarter revenues would be approximately $20 million.  The terms of the amended contract with the DoD authorize delivery of BioThrax ahead of schedule.

The company is also preparing its response to a May 7, 2007 request for proposal from the DoD for a follow-on contract for the supply of up to 14 million doses of BioThrax to the military for its active immunization program.  The request for proposal contemplates a contract term of one base year and three option years.

“Emergent BioSolutions and the DoD have a longstanding relationship and we are pleased to continue to provide doses of BioThrax for the military’s ongoing active immunization program,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.  “By repeatedly fulfilling our commitments to the U.S. Government, we continue to strengthen our reputation for reliability—an essential element of a successful partnership with the government.  I am proud of our role in helping to protect our nation’s troops against biological threats.”

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue for the second quarter of 2007, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under BioThrax sales contract with the U.S. Department of Defense, including the timing of deliveries under that contract; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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U.S. Department Of Health And Human Services Remains Committed To Procurement Of Biothrax® Under Current Contract

Tuesday, June 30th, 2009

ROCKVILLE, MD, November 19, 2007 —Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Department of Health and Human Services (HHS) has reaffirmed its commitment to continue to purchase BioThrax® (Anthrax Vaccine Adsorbed) under the current contract for 18.75 million doses that provides for a firm fixed price of $400 million plus an additional $34 million upon receipt of regulatory approval of four year dating.  In a recent notification, HHS stated the following:

HHS plans to continue purchasing BioThrax under the contract, which is for 18.75 million doses; and

HHS is diligently working with the Department of Defense (DOD) and other federal partners, as required by Homeland Security Presidential Directive 21 and recommended by a recent Government Accountability Office report, to address effective stockpile management to meet collective requirements.

“We are pleased that HHS has reaffirmed its commitment to the continued procurement of BioThrax under our recent contract, and we are confident that BioThrax will remain a critical component of our nation’s preparedness efforts,” said Fuad El-Hibri, Chief Executive Officer and Chairman of Emergent BioSolutions.  “Emergent BioSolutions looks forward to continuing our long standing relationship with the U.S. government to protect our military men and women as well as Americans at home.”

In the last few months, the company announced significant progress in achieving its business objectives including:

  • the upward revision to its revenue guidance to reflect 2007 full-year revenue growth of between 16% and 18%, and a continued commitment to profitability in 2007, which will represent the sixth consecutive year of full year profitability;
  • the signing of a $448 million three-year contract with the HHS that included $400 million for delivery of 18.75 million doses of BioThrax, $34 million upon receipt of regulatory approval of four year dating, and $11.5 million in connection with a post-exposure indication for BioThrax;
  • the completion of the first delivery of BioThrax to HHS under the new contract, which generated revenue of approximately $42 million;
  • the completion of a clinical study in support of the post exposure prophylaxis indication for BioThrax, which triggered an $8.8 million milestone payment from HHS;
  • the receipt of a $9.5 million award from HHS to fund the continued development of the company’s anthrax immune globulin therapeutic candidate; and
  • the positive completion of a double-blind, placebo-controlled Phase II clinical trial of its single-dose, oral typhoid vaccine candidate in a pediatric population, with the vaccine being well-tolerated and immunogenic.

“These developments demonstrate consistent progress during 2007 towards expanding our business and achieving long-term growth,” he continued. “The HHS contract provides us with a baseline of revenue sufficient to support the growth and profitability of our company in 2008 and 2009, and we intend to expand our revenue sources, including with the Department of Defense, other domestic customers, and internationally with foreign governments based on projects we have been actively pursuing while remaining fiscally responsible in the management of our operations.  Emergent BioSolutions remains focused on building upon our past success and further expanding our presence as an innovative biopharmaceutical company with a simple mission – to protect life.”

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission – to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2007, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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