Fuad El-Hibri Info » U.S. Food and Drug Administration

Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

admin — Fri, 11 Dec 2009 11:36:09 +0000

by Nick Rees on December 8, 2009

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.”

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Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares

admin — Fri, 14 Aug 2009 11:19:37 +0000

CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.

EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission – to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\’s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their 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. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.

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Emergent BioSolutions Celebrates Initial Public Offering; CEO To Ring Opening Bell on the NYSE

admin — Mon, 03 Aug 2009 14:48:31 +0000

21 November, 2006 GAITHERSBURG, Md.–(BUSINESS WIRE)–Nov. 21, 2006–Emergent BioSolutions Inc. (NYSE:EBS), a biopharmaceutical company that develops vaccines and therapeutics for biodefense and commercial applications and manufactures the only anthrax vaccine approved by the U.S. Food and Drug Administration (FDA), today announced it will be celebrating the Company’s recently completed initial public offering with the ringing of the opening bell of the New York Stock Exchange by Fuad El-Hibri, chairman and chief executive officer, on Wednesday November 22, 2006. “Throughout the Company’s history, our people, science and technology have contributed significantly to safeguarding millions of military personnel and the general population through the delivery of a safe and effective countermeasure against the threat of anthrax infection,” said Mr. El-Hibri. “Tomorrow’s ringing of the opening bell is an opportunity to celebrate our Company and our achievements thus far, while acknowledging the commitment and support of our employees, customers and, now, investors who continue to drive our success.” Emergent BioSolutions’ common stock began trading on November 15, 2006 under the symbol EBS. Emergent is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and immune globulins, that induce or assist the body’s immune system to prevent or treat disease. The Company operates in two business segments: biodefense and commercial. In its biodefense business, the Company develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the Company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. The Company’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the FDA for the prevention of anthrax infection. For more information about BioThrax, please review the package insert located on the Company’s website www.emergentbiosolutions.com. In addition to BioThrax(R), the Company’s biodefense product portfolio includes three biodefense product candidates in preclinical development and a next generation anthrax vaccine program with product candidates in preclinical and Phase I clinical development. The Company’s commercial product portfolio includes a typhoid vaccine candidate and a hepatitis B therapeutic vaccine candidate, both of which are in Phase II clinical development, one vaccine candidate in Phase I clinical development and two vaccine candidates in preclinical development. 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 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 Emergent’s actual results to differ materially from those indicated by such forward-looking statements, including 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; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company’s Registration Statement on Form S-1 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.www.emergentbiosolutions.com

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Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Winner in Greater Washington

admin — Mon, 03 Aug 2009 13:49:51 +0000

ROCKVILLE, Md.–(BUSINESS WIRE)–Emergent BioSolutions Inc. (NYSE:EBS – News) announced today that Fuad El-Hibri, its chairman and chief executive officer, received the Ernst & Young Entrepreneur of the Year^® 2009 Award in the Technology category in Greater Washington. According to Ernst & Young LLP, the award recognizes outstanding entrepreneurs who are building and leading dynamic, growing businesses. Mr. El-Hibri was selected by an independent panel of judges and the award was presented at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.

“It is a tremendous honor to receive this award considering the many biopharmaceutical and life sciences companies in the greater Washington region,” said Mr. El-Hibri. “I am proud of Emergent BioSolutions’ continuous growth and financial strength. These successes are firmly anchored on the entrepreneurial spirit and commitment of our employees. All their contributions, in pursuit of our company mission to protect life, have made this award possible.”

Under Mr. El-Hibri’s leadership, Emergent BioSolutions has expanded its capabilities in the development and manufacture of vaccines and immune-related therapeutics. By strengthening its core biodefense portfolio, which includes the only FDA-licensed vaccine against anthrax disease, Emergent has become the premier biodefense supplier of medical countermeasures to the U.S. government.

The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year and continues to honor entrepreneurs who have demonstrated excellence in such areas as innovation, financial performance, and personal commitment to their businesses and communities. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.

As a Greater Washington award winner, Mr. El-Hibri is now eligible for consideration for the Ernst & Young Entrepreneur of the Year 2009 national program. Award winners in several national categories, as well as the overall national Ernst & Young Entrepreneur of the Year award winner, will be announced at the annual awards gala in Palm Springs, California on November 14, 2009. The awards are the culminating event of the Ernst & Young Strategic Growth Forum, the nation’s most prestigious gathering of high-growth, market-leading companies.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax^® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About Ernst & Young’s Entrepreneur of the Year^® Awards Program

Ernst & Young’s Entrepreneur of the Year^® Award is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur of the Year^® award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.

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Statement By Fuad El-Hibri, Emergent BioSolutions Chairman And Chief Executive Officer, On The Passing of Admiral William Crowe, Jr., Former Board Member

admin — Fri, 31 Jul 2009 13:45:19 +0000

ROCKVILLE, MD, October 19, 2007— Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, issued the following statement on the passing of Admiral William Crowe, Jr., who served on the company’s Board of Directors from 1998-2005.

“I was deeply saddened to learn of the passing of my dear friend and former colleague, the honorable Admiral William J. Crowe Jr. My thoughts are with his family during this difficult time,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

“A benevolent and courageous public servant, Admiral Crowe committed his life to serving the nation. He was a candid man who led with nobility and grace, and never wavered in his commitment to the protection of our country. His compassion and boundless love for his family and friends were matched only by his steadfast integrity and tenacious commitment to the United States military and the field of education. Admiral Crowe’s countless contributions to the American people will not be forgotten, and our nation is fortunate to have known such a dignitary. The Admiral was an invaluable asset to our company, and I will always remember the great strategic insight and disarming humor he brought to every situation. Emergent BioSolutions is a stronger company as a result of his vision and leadership, and I am particularly grateful for his many years of friendship,” he concluded.

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.

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Emergent Biosolutions Signs $448 Million Three Year Contract With Department Of Health And Human Services

admin — Tue, 30 Jun 2009 02:56:34 +0000

ROCKVILLE, MD, September 26, 2007—Emergent BioSolutions Inc. (NYSE: EBS), announced today that it has signed a three year contract with the U.S. Department of Health and Human Services (HHS), with a total value of up to $448 million. Components of the contract include:

$400 million firm fixed-price for delivery of 18.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (SNS);
$34 million for receipt of regulatory approval of 4-year expiry dating for BioThrax payable through a combination of a lump-sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the per dose price to be paid for doses delivered following approval;
up to $11.5 million in milestone payments in connection with advancement towards a post-exposure prophylaxis (PEP) indication for BioThrax; and,
$2.2 million for logistics services and other related support.

The Company anticipates making deliveries for approximately 6 million doses under this contract by year-end 2007. As a result, the company reaffirms its expectation for full year total revenue growth of 10 to 15 percent, with a bias toward the upper end of the range, and full year positive net earnings.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are honored to continue our longstanding relationship with HHS to provide BioThrax as a critical component of our nation’s biodefense stockpile. I applaud the dedication and professionalism of the senior leadership within HHS and Biomedical Advanced Research and Development Authority in completing this important step towards enhancing our domestic biodefense infrastructure. Emergent BioSolutions remains dedicated to working with various government agencies in their commitment to procure medical countermeasures as a primary element of establishing the highest possible levels of biopreparedness.”

Under terms of the contract, HHS will purchase from the company an aggregate of 18.75 million doses of BioThrax through September 2010, for a firm, fixed-price of $400 million. In the event the company receives U.S. Food and Drug Administration (FDA) approval of the company’s pending supplement to its biologics license application (BLA) to extend the shelf life of BioThrax from three years to four years, the company will receive a lump sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the price per dose to be paid for doses delivered following the date of approval, with a total value of approximately $34 million. If FDA approval of 4-year expiry dating is not received during the term of the contract, the company will not be entitled to receive any of the $34 million. The company submitted its supplement for 4-year expiry dating to the FDA in December 2006 and has been providing additional information to the agency in support of its application.

Under the contract, HHS will also provide up to $11.5 million in connection with advancing the company’s program to obtain a PEP indication for BioThrax. The PEP indication, which would expand the use of BioThrax beyond the current pre-exposure prophylaxis indication, is designed to permit the administration of BioThrax in combination with antibiotics following exposure to anthrax. These funds are payable upon the company’s achievement of specific program milestones. The company anticipates that it will receive $8.8 million of this amount in the fourth quarter of 2007.

In addition, under the contract the company has agreed to provide all shipping services related to delivery of doses into the SNS over the contract term, and will receive payment of an additional $2.2 million.

The contract has been funded with Federal funding through the Project BioShield Special Reserve Fund, which was created by an act of Congress in May 2004.

Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to HHS for inclusion in the SNS under a May 2005 supply agreement for 5 million doses valued at $123 million and a May 2006 contract modification for an additional 5 million doses valued at $120 million.

Conference Call & Webcast
Company management will host a conference call at 9:00 am Eastern today, September 26, 2007 to discuss this announcement. Interested parties may participate in the live teleconference by dialing 866/383-8008 or 617/597-5341 or via a webcast accessible at www.emergentbiosolutions.com, under “Investors”. A replay of the teleconference will be available on the company website or by dialing 888/286-8010 or 617/801-6888 and using the passcode 61817264, approximately one hour after the teleconference concludes. The replay will be available through October 10, 2007.

About BioThrax® (Anthrax Vaccine Adsorbed)
BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection. It is approved by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Baccillus anthracis and contains no dead or live bacteria. BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter. Since 1998, approximately 20 million doses of BioThrax have been procured by the U.S. government. During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel. BioThrax cannot cause anthrax infection.

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 performance under our contract with HHS and future payments from HHS to us under the contract, 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 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 June 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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Emergent Biosolutions Announces The Appointment Of Denise Landry As Senior Vice President, Quality

admin — Tue, 30 Jun 2009 01:56:26 +0000

ROCKVILLE, MD, October 9, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Ms. Denise Landry has joined the company as Senior Vice President, Quality with responsibility for managing and overseeing all Quality activities company-wide. Ms. Landry has broad-based quality experience for pharmaceutical and biologics operations, including activities relating to all phases of product development, regulatory submissions, and compliance programs. In addition, Mrs. Landry has extensive experience interacting with regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Medicines and Healthcare Product Regulatory Agency (MHRA) in the United Kingdom.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions stated “I am pleased to welcome Ms. Denise Landry to Emergent BioSolutions as Senior Vice-President, Quality. Her two decades of experience in the Quality programs will be a critical asset to our team. Denise’s first-hand experience and breadth of knowledge make her uniquely qualified for such an important role in our company.”

Ms. Landry joins the company from MGI Pharma Inc. and its predecessor Guilford Pharmaceuticals, where she served as Vice President, Corporate Quality. Prior to her 13 year tenure there, Ms. Landry was the Director Quality Assurance for Pharmaceutical Systems, Inc. and Quality Assurance Director for Smith & Nephew Solopak. She began her career in the quality control field as a Service Quality Manager for Baxter Healthcare Corporation.

“I am very pleased to be joining the management team at Emergent BioSolutions, and I share their commitment to maintaining the highest quality standards in manufacturing and product development,” said Ms. Denise Landry. “I have dedicated my career to this industry and look forward to leading and promoting continuous quality improvement throughout the company as it develops and manufactures products to protect life.”

Mrs. Landry holds a BA in Biology from Fisk University in Tennessee. She is a member of the American Society of Quality Control and the Parenteral Drug Association.

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 disease. 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 any 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 the execution of our strategy by our executive team; 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; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 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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Emergent Biosolutions Receives Development Contract From Niaid/Barda To Fund Continued Development Of Anthrax Therapeutic

admin — Tue, 30 Jun 2009 01:44:32 +0000

$9.5 million development contract to fund non-clinical and clinical studies of anthrax immune globulin (AIG) over next 24 months

ROCKVILLE, MD., September 27, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has received a development contract, valued at up to $9.5 million, in support of non-clinical and clinical studies of the company’s anthrax therapeutic, or AIG, product candidate. This product candidate is an immune globulin being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease following exposure to anthrax.

This development contract has been funded in whole or in part from Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSN272200700034C.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are very pleased to have continuing support for AIG from NIAID and BARDA and commend the leadership throughout HHS for their commitment to funding the development of effective medical countermeasures against this deadly biological agent. With the continued development funding of our AIG candidate, in conjunction with the $448 million contract with HHS announced yesterday regarding procurement of 18.75 million doses of our BioThrax anthrax vaccine for the strategic national stockpile, we are very encouraged by the government’s support of our anthrax franchise. We look forward to continuing to be a leading participant in the U.S. government’s effort to build a robust domestic biodefense industry.”

Under terms of the development award, the funds will be used to conduct various studies on AIG, including (i) non-clinical studies in support of efficacy; and (ii) a Phase I/II clinical study to evaluate pharmacokinetics and safety. Previously, in August 2006 the company received $3.9 million from NIAID in support of the company’s AIG program. When combined with the $9.5 million under this new development award, the total amount of government funding for AIG to date is over $13 million.

About Anthrax Immune Globulin (AIG)
Emergent BioSolutions’ anthrax immune globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body and for whom the use of the vaccine is no longer an effective option. If successfully developed, AIG could be prescribed for administration in these circumstances either as a monotherapy or in conjunction with an antibiotic.

AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), Emergent BioSolutions’ anthrax vaccine, which is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

The company has collected a sufficient amount of plasma to initiate manufacturing of AIG under cGMP using a validated and approved process. This manufacturing process entails fractionating the plasma and purifying the immune globulin. The company has signed an exclusive license with Talecris Biotherapeutics, Inc., a North Carolina-based biopharmaceutical company and leading fractionation provider, to fractionate, purify and fill AIG at Talecris’ FDA-approved facilities. To date, the first full-scale lot of AIG has been manufactured under cGMP requirements at Talecris. The company has scheduled plans to complete a second full-scale lot of AIG.

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 performance under our contract with HHS and future payments from HHS to us under the contract, 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 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 June 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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Emergent Biosolutions Announces Expansion Of Board Of Directors And Appointment Of Dr. Sue Bailey To The Company’s Board Of Directors

admin — Tue, 30 Jun 2009 01:32:05 +0000

Dr. Bailey brings DoD and media relations expertise to the company’s Board

ROCKVILLE, MD, June 15, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today that at a regularly scheduled meeting of its board of directors the board passed a resolution authorizing the expansion of the total number of members of the board to eight. The board also unanimously appointed Sue Bailey, M.D., as a Class III director, for a two-year term that will expire at the 2009 annual meeting of stockholders.

“I am delighted to welcome Dr. Bailey to the Emergent BioSolutions Board of Directors. Her extensive experience in managing complex organizations and healthcare-related issues for both the federal government and private corporations and her expertise in media relations will contribute greatly to our ability to meet our nation’s need for bioterrorism countermeasures and to create shareholder value,” said Fuad El-Hibri, Emergent BioSolutions’ chairman and chief executive officer.

Dr. Bailey served as a news analyst for NBC Universal from 2001 to 2006, focused on national security, bioterrorism, environmental safety and public health issues. Dr. Bailey also served as Administrator for the National Highway Traffic Safety Administration from 2000 to 2001, as Assistant Secretary Of Defense (Health Affairs) from 1998 to 2000, and as Deputy Assistant Secretary Of Defense (Clinical Services) from 1994 to 1995. During her tenure with DoD Health Affairs, Dr. Bailey headed the $17 billion military medical system, with responsibility for protecting American military forces from combat causalities, disease, environmental hazards, and biochemical warfare.

“Protecting America’s military men and women against acts of bioterrorism and safeguarding citizens against infectious diseases has been the focus of my career,” said Dr. Bailey. “I am pleased to be joining the Board of Emergent BioSolutions where I can help guide the company’s development of medical countermeasures that can protect the lives of those most at risk.”

Dr. Bailey is a board certified physician whose clinical and academic background included a faculty position at Georgetown University Medical School. In addition, she was formerly a Navy officer, having achieved the rank of Lt. Commander, U.S. Navy Reserve. Dr. Bailey also serves as an advisor or member of the board of directors for a variety of industry, academic and trade healthcare and safety-oriented organizations.

Dr. Bailey holds a degree from the University of Maryland and her medical degree from the Philadelphia College of Osteopathic Medicine. She completed her internship and residency at George Washington University and completed a medical post-graduate fellowship at Johns Hopkins University.

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 performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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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Emergent Biosolutions Announces Management Changes

admin — Tue, 30 Jun 2009 01:26:38 +0000

ROCKVILLE, MD, May 16, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today the consolidation of the president and chief operating officer position. With this change, Daniel J. Abdun-Nabi, the company’s president, will also take on the role of chief operating officer. In this combined role, Mr. Abdun-Nabi will oversee all of the company’s product development, manufacturing and corporate affairs activities. Mr. Abdun-Nabi will continue to report to Fuad El-Hibri, chairman and chief executive officer of the company.

Specifics of other management changes, which are also effective immediately, include:

R. Don Elsey is being promoted to the position of senior vice president finance and administration. Mr. Elsey was formerly vice president finance and administration. Mr. Elsey will continue to retain his responsibilities as chief financial officer for the company and will now assume additional responsibility for investor relations and human resource activities. Mr. Elsey will continue to report to Mr. El-Hibri, chairman and chief executive officer.

Kyle W. Keese is being appointed to the position of senior vice president corporate affairs with responsibility for public affairs, marketing and sales and corporate development. Mr. Keese was formerly senior vice president marketing and communications.

Thomas K. Zink, M.D. is assuming the responsibility for clinical development in addition to medical affairs. Dr. Zink, formerly senior vice president medical affairs, is now senior vice president medical and clinical development. Dr. Zink will continue to retain his responsibilities as chief medical officer for the company and, in that capacity, will continue to report to Mr. El-Hibri, chairman and chief executive officer.

Edward J. Arcuri, Ph.D., is resigning his position as chief operating officer. The resignation is effective immediately.

“Today’s senior management consolidation and associated changes within our corporate organization are designed to strengthen the integration of our development and manufacturing organizations and to enhance the company’s positioning and capabilities in both the biodefense and commercial immunobiotic markets,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.

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 or 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 performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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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Emergent Biosolutions Anticipates 2Nd Quarter Biothrax Revenues Of Approximately $20 Million Based On Accelerated Delivery To Department Of Defense

admin — Tue, 30 Jun 2009 01:22:10 +0000

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.”

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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Statement By Fuad El-Hibri, Emergent BioSolutions Chairman And Chief Executive Officer, On The Passing of Admiral William Crowe, Jr., Former Board Member

admin — Tue, 30 Jun 2009 01:07:48 +0000

“I was deeply saddened to learn of the passing of my dear friend and former colleague, the honorable Admiral William J. Crowe Jr. My thoughts are with his family during this difficult time,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

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Emergent Biosolutions Announces Dr. Stephen Lockhart Joins Company To Lead Commercial Product Development Subsidiary

admin — Tue, 30 Jun 2009 01:00:20 +0000

Dr. Lockhart Brings Top-Tier Pharma Leadership to Development of Company’s Commercial Product Portfolio

ROCKVILLE, MD, October 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Dr. Stephen Lockhart has been appointed President, Emergent Product Development UK. Dr. Lockhart will be based at the company’s office located in Wokingham, England, and his responsibilities will include providing oversight, leadership, direction and execution of development programs in both the United Kingdom and Germany. These programs include, among others, the following product candidates: a single-dose oral typhoid vaccine that recently completed a Phase II clinical trial; a drinkable Hepatitis B therapeutic vaccine in a Phase II clinical trial; and a group B streptococcal vaccine candidate that completed a Phase I clinical study and for which further clinical studies are being planned in collaboration with the National Institute of Allergy and Infectious Diseases.

“It is with great pleasure that I welcome Dr. Lockhart to the company,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We are very fortunate to have someone at the helm of our commercial product development efforts with such broad and varied expertise in vaccinology, as well as an intimate understanding of the critical elements involved in the biopharmaceutical industry. His experience in bringing vaccines through clinical development and regulatory approval makes him ideally suited to lead our commercial product development programs.”

Dr. Lockhart has over fifteen years of experience in vaccine development and most recently was Assistant Vice President and Global Head of Bacterial Vaccine Clinical R&D at Wyeth. Prior to joining Wyeth in 1990, Dr. Lockhart served as a Medical Adviser with Janssen Pharmaceutical from 1986-1989.

“I am pleased to be joining Emergent BioSolutions and am particularly excited about leading product development for such a diverse portfolio,” said Dr. Lockhart. “The success of our efforts will potentially help millions of people and I am eager to apply my years of experience towards this exciting portfolio and the mission of the company,” he continued.

Dr. Lockhart is an internationally recognized leader in vaccine-related product development and has been the recipient of multiple awards. He accepted the Prix Galien, a renowned award given for excellence in pharmaceutical innovation, on behalf of Wyeth in both 2000 and 2005 and received the Wyeth Research President’s Award in 2000 for leading the development of Meningitec, a meningitis C vaccine.

Dr. Lockhart has an MA from Cambridge University and received his advanced medical and research degrees from Oxford University. In 1983 he became a Member of the Royal College of Physicians and in 1988 received his Diploma in Pharmaceutical Medicine. After becoming a Member for the Faculty of Pharmaceutical Medicine in 1991, Dr. Lockhart was inducted as a Fellow of the Faculty of Pharmaceutical Medicine in 2003.

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 any 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 the execution of our strategy by our executive team; 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; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 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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Emergent Biosolutions Announces Results From Annual Meeting Of Stockholders

admin — Tue, 30 Jun 2009 00:53:44 +0000

ROCKVILLE, MD, June 14, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today the results of the company’s 2007 annual meeting of stockholders, which took place today at the Hyatt Regency Bethesda at 10:00 am Eastern.

There were present, in person or represented by proxy, the holders of more than a majority of the shares of the outstanding common stock of the company, thus constituting a quorum.

Proposal 1—Election of Directors
The following individuals were elected Class I directors of the company to serve for a three-year term expiring 2010: Fuad El-Hibri, Jerome M. Hauer and Ronald B. Richard.

Proposal 2—Ratify Selection of Ernst & Young LLP as the Company’s Independent Registered Public Accounting Firm
The proposal to select Ernst & Young LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2007 successfully passed.

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.

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

admin — Tue, 30 Jun 2009 00:50:24 +0000

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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