Company management will host a conference call at 5:00 pm Eastern on March 10, 2011 to discuss the financial results for the fourth quarter and full twelve months of 2010, recent business developments and the forecast for 2011. The conference call will be accessible by dialing 888/713-4205 or 617/213-4862 (international) and providing passcode 91804244. A webcast of the conference call will be accessible from the company’s website at www.emergentbiosolutions.com, under “Investors”.

Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website: www.theconferencingservice.com/prereg/key.process?key=PWXFXF88Y.

A replay of the conference call will be accessible, approximately two hours following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 77289976. The replay will be available through March 24, 2011. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

SOURCE: Emergent BioSolutions Inc.

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Along with colleagues from industry, education, and government, Fuad El-Hibri is a member of the IBRA Board of Directors. The Alliance helps provide opportunities for students to build and develop important elements of scientific leadership, giving students the opportunity to grow into exceptional biomedical research leaders. IBRA firmly believes in the ability of outstanding researchers to transform today’s promise of cures and treatments into available therapies, drugs and prevention measures that enhance the world’s health.

Since its inception in 2000, the Scholars program has recruited gifted, inquiring, creative and dedicated minds for a uniquely designed doctoral program of training and investigative, exploration to challenges some of the worlds greatest minds to achieve IBRA’s main goal to create the premier PhD and MD/PhD program.

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The NIH-Oxford-Cambridge Scholars Program (Scholars Program) was created in 2001 to revolutionize the way in which the most talented biomedical PhD and MD/PhD students are trained. Every pedagogical and logistical element of the Scholars Program was designed to produce scientists who will generate high-impact, breakthrough results at the speed at which science, government and industry must move to meet the demanding healthcare needs of a global population. The Scholars Program trains more “prestige” scholars (Rhodes, Marshall, Churchill, Gates, Howard Hughes Medical, Fulbright, and Goldwater) than any other program in the world. To date, the Scholars Program has produced 45 doctoral graduates and currently has 113 scholars enrolled.

“Emergent is pleased to welcome the future leaders in scientific research and discovery, who are already engaged in and contributing to public health improvement by exhibiting academic excellence,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions and member of the Alliance Board of Trustees. “We congratulate them for their exceptional talent, which brought them to the scholars program and which will guide them to its completion.”

“The Alliance is most grateful for Mr. El-Hibri’s private sector perspectives which have helped to shape the values, culture, goals and metrics of success of the Scholars Program,” said Ann Marie Drucker, Alliance President.

Over 35 scholars participated in the symposium and laboratory tour that was held at Emergent’s product development facility in Gaithersburg, Maryland.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. 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 International Biomedical Research Alliance

The International Biomedical Research Alliance (Alliance) was created in 2005 as a private, not-for-profit (501(c)(3) providing expertise and resources to assure the NIH-Oxford-Cambridge Scholars Program’s financial viability and unwavering adherence to absolute standards of excellence, continuous innovation and dedication to accelerated discovery for generations to come. In pursuit of its mission, the Alliance provides philanthropic, scientific and industry resources dedicated to developing the NIH-Oxford-Cambridge Scholars Program into the pre-eminent biomedical training pathway for leaders in the life sciences.

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ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million.  Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010.  This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.

The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax^® procurement contract with the US Centers for Disease Control and Prevention (CDC).  This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010.  This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010.

“This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent.  “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.”

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility.  We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. 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^® (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 BioThrax^®

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection.  It is indicated for the active immunization of adults who are at high risk of exposure to anthrax.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis.  Since 1998, the U.S. government has procured over 45 million doses of BioThrax.  During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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 potential future securities offering, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax^® procurement; our ability to obtain new BioThrax^® sales contracts; 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; the success of 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; 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, 2010 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 Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax^(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”

This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.

The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. 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 BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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 potential future securities offering, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax^(R) procurement; our ability to obtain new BioThrax^(R) sales contracts; our plans to pursue label expansions and improvements for BioThrax^(R); our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; 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, 2010 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 recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism,” said Allen Shofe, senior vice president public affairs of Emergent BioSolutions.  “As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments.”

About BioThrax

BioThrax is the only U.S. FDA-licensed vaccine for the prevention of anthrax infection.  It is indicated for the active immunization of adults who are at high risk of exposure to anthrax.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax.  During that time period, more than 9.5 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Safety Information for BioThrax^®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. 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^® (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.

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 potential future securities offering, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax^® procurement; our ability to obtain new BioThrax^® sales contracts; 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; the success of our ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 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 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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An anthrax vaccine discovered and initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has been acquired by a Maryland-based firm for advanced development that could lead to eventual licensure of the product by the Food and Drug Administration.

Fuad El-Hibri Next Generation Anthrax Vaccine

Jun 15
Comments

Fuad El-Hibri next generation anthrax vaccine

FOR IMMEDIATE RELEASE CONTACT: Caree Vander Linden
May 12, 2008 (301) 619-2285
Caree.Vander-Linden@amedd.army.mil

USAMRIID’s Next Generation Anthrax Vaccine Acquired for Advanced Development

According to company officials, Emergent BioSolutions Inc. has acquired the next generation anthrax vaccine, as well as the technology on which it is based. This vaccine candidate was patented by USAMRIID and previously licensed to a company called VaxGen, which had pursued advanced development since 2002 under a contract from the U.S. Department of Health and Human Services.The vaccine uses recombinant protective antigen, or rPA, a protein secreted by the anthrax bacterium, Bacillus anthracis. This protein induces the body’s immune system to produce antibodies against the bacteria’s toxins. In several nonhuman primate studies conducted at USAMRIID, rPA has demonstrated the ability to induce a high level of protection against inhalational anthrax—the type most likely to occur following a bioterrorist event.

“We believe this acquisition will facilitate the continued development of this promising anthrax vaccine candidate,” said Colonel George W. Korch, Jr., commander of USAMRIID. “We are excited about the future prospects for rPA as an effective medical countermeasure for the nation’s biodefense.”

Anthrax is caused by spores and most commonly occurs in wild and domestic mammals, although it has the potential to be used as a biological threat agent. Symptoms vary depending on the route of exposure; however, sore throat, mild fever, and muscle aches usually begin within 7 days of exposure. Severe breathing difficulty, shock, and meningitis can follow, and as the bacteria multiply in the lymph nodes, toxemia progresses and the potential for widespread tissue destruction and organ failure increases. Up to 90 percent of untreated cases of inhalational anthrax result in death. Obtaining an alternative for the currently licensed anthrax vaccine would provide the Department of Defense—and the nation—with additional options in protecting against this threat.

USAMRIID’s proprietary technology also has a number of potential manufacturing advantages, including the ability to express full-length soluble anthrax PA in a non-toxic, non

spore-forming strain of the anthrax bacterium. When full-length rPA is expressed in anthrax bacteria, it is secreted into the culture fluid, from which it can be isolated in a highly purified form. This material also has the potential to provide broader protection against anthrax.

“By acquiring this particular vaccine candidate, Emergent will be able to leverage over a decade of development work conducted at USAMRIID and 5 years of experience and advanced development work conducted by VaxGen, in order to continue the development of this vaccine through to licensure,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.

USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Department of Defense Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. While USAMRIID’s primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil

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Posted in Anthrax Vaccine, El-Hibri Fuad, Emergent BioDefense, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: Anthrax, Emergent BioSolutions, Fort Detrick, Infectious disease, United States Army Medical Research Institute of Infectious Diseases, United States Department of Health and Human Services, US Army Medical Research Institute of Infectious Diseases, USAMRIID, VaxGen

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El-Hibri Fuad, Fuad El-Hibri, Fuad Elhibri, Tuberculosis Vaccine

Tuberculosis Vaccine by Fuad El-Hibri

Fuad El-Hibri’s EBS is Developing TB Vaccine

Jun 15
Comments

Fuad El-Hibri’s EBS is Developing TB Vaccine

“The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort,” said Jerald C. Sadoff, president and CEO of Aeras, in a statement.

“This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world’s deadliest diseases,” said Fuad El-Hibri, chairman and CEO of Rockville biotech Emergent BioSolutions, which is teaming with the University of Oxford on the TB project.

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Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri, TB Vaccine, Tuberculosis Vaccine
Tags: Aeras Global TB Vaccine Foundation, Chief executive officer, Conditions and Diseases, Global health, Health, Infectious Diseases, Oxford University, Tuberculosis

Fuad El-Hibri Key Executive at Emergent

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