Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin’s B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma. TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical(TM) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.

“Although patients show a high rate of clinical response to first line therapies they often relapse and in many cases, develop a resistance to treatment,” said Dr. Scott Stromatt, Vice President of Clinical Research and Chief Medical Officer at Emergent BioSolutions. “Our preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone. TRU-016 is also synergistic with rituximab in preclinical models. Based on these data, as well as data from our ongoing clinical studies of TRU-016 for chronic lymphocytic leukemia, we believe that TRU-016 in combination with bendamustine and rituximab could produce meaningful results in patients with indolent NHL.”

The Phase 1b portion is a dose escalation study to determine the Phase 2 dose of TRU-016 given in combination with rituximab and bendamustine. In this portion of the trial, up to 12 patients will receive two dose levels of TRU-016 in combination with rituximab and bendamustine administered intravenously. The primary safety endpoint for the Phase 1b portion of the study is the incidence of dose-limiting toxicities (DLTs).

The Phase 2 portion will be an expansion study of approximately 76 additional patients to examine the safety and efficacy of TRU-016 in combination with 375 mg/m² of rituximab and 90 mg/m² of bendamustine, versus bendamustine and rituximab. The primary efficacy endpoint for the Phase 2 portion of the study is complete response (CR) rate as determined by using the Revised Response Criteria for Malignant Lymphoma. The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.

The total expected enrollment for both phases of this study is expected to be 88 patients, all of whom have a confirmed diagnosis of relapsed indolent B-cell lymphoma, and who have failed prior treatments. Study enrollment is expected to be completed by the end of 2012. Additional information about this Phase 1b/2 clinical study can be found at www.clinicaltrials.gov (protocol 16011).

About non-Hodgkin’s Lymphoma (NHL)

According to the National Cancer Institute, there are approximately 65,980 cases of NHL diagnosed each year, with close to 30% of these cases resulting in death. NHL is a broad range of malignant lymphoid disorders that are categorized on the basis of aggressiveness and cell of origin. Indolent or slow-growing NHL causes few symptoms, particularly early in the natural history of the disease, making early detection difficult. The majority of patients with indolent NHL present with Stage III or IV disease. Most patients with NHL requiring treatment receive rituximab in combination with chemotherapy as initial treatment; however, many patients become refractory to both chemotherapy and rituximab.

About TRU-016

TRU-016 is a CD37-directed protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott. TRU-016 uses a different mechanism of action than currently marketed CD20-directed therapies. As a result, TRU-016 may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or other immunotherapeutics. TRU-016 is currently in Phase 1b/2 development for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.

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.

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 the success of our ongoing and planned preclinical studies and clinical trials; 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 June 30, 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 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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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.”

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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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Maryland Governor Martin O'Malley and Fuad El-Hibri

ROCKVILLE, MD, July 16, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon cutting ceremony, led by Governor Martin O’Malley and Fuad El-Hibri, Emergent’s chairman and chief executive officer, to mark the formal opening of Emergent Manufacturing Operations Baltimore.  Emergent’s new facility consists of 56,000 square feet of manufacturing and office space, and includes multiple manufacturing suites designed to support clinical and commercial manufacture of the company’s rPA, anthrax monoclonal, and tuberculosis product candidates, among others.

“The Baltimore facility symbolizes Emergent’s continued investment in manufacturing as one of its core competencies and competitive advantages,” said Mr. El-Hibri.  “It is also a testament to Emergent’s commitment to the State of Maryland, where we are proud to be a key contributor to economic development and job growth.”

“Maryland has a reputation of being a haven for thriving life sciences and biotechnology companies, thanks to industry leaders like Emergent BioSolutions,” said Governor O’Malley. “Emergent’s expansion into Baltimore, through the purchase and re-commissioning of this facility, enables significant investment in the biotech infrastructure already in place and ensures that high-paying, highly-skilled jobs are created and remain in Maryland.”

Emergent employs over 680 employees across the globe, with 180 employees located in Maryland, where, aside from the Baltimore manufacturing facility, its corporate headquarters and one of its product development sites are located.  The opening of this new facility could create an additional 120 jobs in the next five years.

“The opening of this new biopharmaceutical facility is good news for three reasons: jobs, jobs and more jobs for Maryland,” said Senator Barbara Mikulski (MD-D). “To keep our state competitive in the global economy, we have to create and support Maryland’s jobs of the future, like the innovative life sciences jobs at Emergent BioSolutions. I’m proud that East Baltimore has been selected to house a facility dedicated to research that will keep Americans healthy and safe.”

“I’m pleased to welcome Emergent BioSolutions to Baltimore,” said Congressman John Sarbanes (MD-D).  “This manufacturing facility helps Maryland maintain its status as a leader in the bioscience industry and brings more than 100 high paid, high skilled jobs for Marylanders.”

“Baltimore City is excited about Emergent BioSolutions’ decision to invest here, which will create many jobs and contribute a great deal to the Baltimore biotech industry,” Baltimore Mayor Stephanie Rawlings-Blake said.  “I welcome Emergent BioSolutions to Baltimore City and look forward to the company’s growth in one of Baltimore’s key industries.”

The company is currently working on modifying and re-commissioning the facility.  Planned facility modifications will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process development timelines.  The facility previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization to produce a number of products approved by the FDA and the European Medicines Agency.

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; 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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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

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 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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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 6^th 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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