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Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax

Thursday, July 7th, 2011

ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June 23rdthat the Singapore Health Sciences Authority (HSA) has approved Emergent’s product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.

“Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon.”

HSA is the statutory board of the Singapore Ministry of Health that administers the country’s regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore.

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 http://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. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit http://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 2011, 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 or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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.

SOURCE: Emergent BioSolutions Inc.

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Emergent BioSolutions Starts Phase I Clinical Trial for Third Generation Anthrax Vaccine

Wednesday, January 5th, 2011

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909.

“Emergent is pleased to commence this clinical trial in support of the U.S. government’s multiple product strategy to strengthen the nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government’s growing arsenal of medical countermeasures.”

The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.

This Phase I trial is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global 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 and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company 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 the success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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 September 30, 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.

SOURCE: Emergent BioSolutions Inc.

Fuad El-Hibri Recognized by Vilcek Foundation

Friday, December 10th, 2010

The Vilcek Foundation was established in 2000 by Jan and Marica Vilcek, immigrants from the former Czechoslovakia. The Foundation was established with the aim of raising public awareness around immigrants’ contributions to the sciences, arts, and culture in the United States.  The Foundation’s mission was inspired by the couple’s careers in science and art, as well as their personal experiences and appreciation for the opportunities given to them as newcomers to the United States.  The Foundation showcases immigrant artists and performers in their New York gallery, awards the annual Vilcek Prizes, and sponsors numerous events such as the Santa Fe Opera and Hawaii International Film Festival.

In the 2010 Spring newsletter, the Vilcek Foundation recognized Fuad El-Hibri, Chairman and CEO of Emergent BioSolutions, Inc.  This is a summary of their report.  The original can be found here:

http://www.vilcek.org/news_articles/newsletters/2010/spring/newsletter_spring2010.html

In addition to his accomplishments in the business world, El-Hibri founded the El-Hibri Charitable Foundation in 2001 in honor of his father, Ibrahim El-Hibri. The Foundation annually awards the El-Hibri Peace Education Prize to peace educators.  It also funds other programs aligned with its four part mission statement promoting Peace Education, Interfaith Dialogue, Humanitarian Aid, and Social Justice.

El-Hibri credits much of his success in the business and philanthropic world to his immigrant background.  He was raised in Europe, North Africa, and the Middle East but always knew he wanted to attend college in the United States. After being accepted to Stanford that dream became a reality.  After completing his undergraduate degree at Stanford he received his Master’s degree from Yale. This international background instilled in El-Hibri the desire to encourage dialogue between different cultures which in 2007 lead to the annual El-Hibri Prize for Peace Education.

“We are trying to get to the crucial goal of establishing a more evident culture of peace,” said Zen Hunter-Ishikawa, Vice President of Operations at El-Hibri Charitable Foundation.  The Prize for Peace Educators awards individuals who have made major contributions to the field of peace education.  Past winners of the prize include Scott Kennedy, former Mayor of Santa Cruz, California, and Abdul Aziz Said, professor at American University in Washington D.C.

“It’s taken some time to get organized,” said El-Hibri, “So it’s only been the last few years we’ve been able to focus on our programs.  We hope to grow significantly over the years.”

Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

Thursday, July 15th, 2010

ROCKVILLE, Md., Jul 14, 2010

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.

The El-Hibri Foundation Launches Website

Wednesday, July 14th, 2010

The El-Hibri Foundation is a nonprofit organization with the goal of fostering dialogue between various religions and encouraging nonviolent solutions to global challenges affecting humankind.  The Foundation has a new website at www.elhibrifoundation.org.

The Foundation, lead by Chairman of the Board of Trustees Fuad El-HIbri, is divided into four different initiatives: The Peace Education Initiative, The Interfaith Dialogue Initiative, The Humanitarian Aid Initiative, and The Social Justice Initiative.

Fuad El-Hibri awards the 2009 Peace Education award

Fuad El-Hibri awards the 2009 Peace Education award

The Peace Education Initiative focuses on conflict resolution, embracing cultural diversity, and supporting cross-cultural approaches to peace-building.  The Interfaith Dialogue Initiative focuses on supporting understanding between the three Abrahamic faiths: Islam, Judaism and Christianity.  The Humanitarian Aid Initiative provides grants to organizations that aim at delivering education and medical care to the disadvantaged.  The last of the four initiatives is the Social Justice Initiative.  The Social Justice Initiative addresses issues of equality, justice and human rights, especially for women and children.

The El-Hibri Foundation promotes these four initiatives through the provision of grants.  Since its creation in 2001, the Foundation has given away 36 grants totaling over 8.2 million dollars.

For more information on the El-Hibri Foundation visit their website:  www.elhibrifoundation.org

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Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments

Wednesday, July 7th, 2010

ROCKVILLE, MD, June 24, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) led by CEO Fuad El-Hibri,announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations.  The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

“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.

Fuad El-Hibri and Healthcare Reform

Friday, April 16th, 2010
Fuad El Hibri and Healthcare reform

Fuad El Hibri

Fuad El-Hibri serves on the Advisory Board for the Yale Healthcare Conference, a joint effort between the Yale School of Management and the Health Professional Schools at Yale University.   The 6th annual healthcare conference was held on April 9, 2010 in New Haven, CT.  The conference topic was “Re-Forming Healthcare: Excellence in a Transforming System” and brought together professionals, academics, and students to engage in an instructive conversation about current healthcare issues.  The conference addressed the challenges key stakeholders will face in a changing healthcare system and offered information on how to foster continued excellence.  Emergent Biosolutions, LLC, led by CEO and Yale School of Management alumnus, Fuad El-Hibri, co-sponsored the conference.  For more information, please see http://www.yalehealthcare.com/advisory.php

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