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.

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.

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.

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

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

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

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

About Emergent BioSolutions Inc.

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

About the NATO Parliamentary Assembly

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

“Emergent 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.

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…..

Professional Background Mr. Fuad El-Hibri is the Chairman and Chief Executive Officer of Emergent BioSolutions Inc. (Emergent), a publicly traded biopharmaceutical company focused on developing, manufacturing and commercializing vaccines and therapeutics to prevent and treat life-threatening diseases. The company’s current marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only FDA-licensed vaccine for pre-exposure prophylaxis of anthrax disease. The company is also investing heavily in the development of a broad pipeline of products that address specific global unmet medical needs, including Typhoid, Tuberculosis, Hepatitis B and Chlamydia.

Mr. El-Hibri has extensive experience in the biopharmaceutical industry beginning with Porton Products, Ltd. (Porton), a mid-sized biotechnology company in the United Kingdom. Subsequent to the successful marketing and …

More about me

Last name

Fuad El-Hibri

Date of birth

19/04/1953

Location

(Baden-Wurttemberg)
Germany

Native language

English

Company

BioSolutions Inc.

Profession

Business & Administration (Manager)

Tags

• pharmacy
• ceo
• anthrax
• fued el-hibri
• biosolutions inc.