Initial deliveries under this award are expected to begin in 2011 with 8.5 million doses scheduled to be delivered during the first year of a five-year contract. The company may modify the timing of deliveries depending on manufacturing yields and other factors.

“Emergent is proud to be able to contribute to the U.S. government’s program of protecting the nation from the threat of anthrax,” said  Fuad El-Hibri. “This 5-year award provides for uninterrupted supply of this critical biodefense countermeasure while addressing the government’s mandate to reduce spending across all programs. In coming to agreement, Emergent and the  Centers for Disease Control and Prevention worked diligently to establish business terms that incorporate substantial price concessions.”

About Emergent BioSolutions Inc.

Emergent BioSolutions 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.

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 55 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 2.6 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 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 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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2. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
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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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“Emergent is pleased to receive Fast Track Designation for NuThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Expedited regulatory review could mean more frequent communications with FDA, priority review of Biologics License Applications (BLA) for our vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.”

The Phase 1b trial for NuThrax 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, 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”, “may”, “would”, “will”, 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 preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the rate and degree of market acceptance 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 plans to pursue label expansions and improvements for BioThrax; 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, 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 its progress towards early completion of its original procurement contract to supply 14.5 million doses of BioThrax,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “Upon completion of this delivery, anticipated to occur as early as June, the company will focus on delivering the additional 3.42 million doses under the modified procurement contract. With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years.”

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.

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 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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2. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
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The open-label, multi-center, active-controlled study is expected to enroll up to 114 bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase Ib portion of the study will determine a safe and tolerable dose of TRU-016 in combination with bendamustine in up to 14 patients with relapsed CLL. The primary endpoint for the Phase Ib portion is the incidence of dose-limiting toxicities.

The Phase II portion of the study will evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with standalone bendamustine treatment in a total of 100 randomized patients. The primary endpoint for the Phase II portion of the study is an overall response rate as defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Secondary endpoints include complete and partial response rates as defined by the 1996 National Cancer Institute (NCI) criteria, progression-free survival, duration of response, and improvement in quality of life and disease symptoms.

The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.

“Given the strong TRU-016 preclinical combination data, and the positive clinical results from the single agent dose escalation study, we believe human clinical evaluation of TRU-016 in combination with bendamustine could yield meaningful results,” said Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions. “The dose escalation study in CLL continues to demonstrate that TRU-016 is well tolerated and clinically active and we look forward to Phase I combination data from this study, as well as the planned Phase I combination study for follicular Non-Hodgkin’s Lymphoma.”

Additional information about this Phase Ib/II clinical study can be found on www.clinicaltrials.gov (protocol 16201).

In December 2010, data were presented at the 52^nd Annual Meeting of the American Society of Hematology (ASH) from a Phase I TRU-016 monotherapy, dose escalation trial involving 57 patients who have had a median of four previous therapies and a median of two prior anti-CD20 therapies. Of the 57 patients, 46% received their last treatment for CLL less than 6 months before entering the study. Genomic data were available for 53 patients, the majority of which (n=35) had high-risk genomic features for CLL, including del(17p) and/or del(11q).

Pharmacokinetic data demonstrated rapid clearance of TRU-016 in the lower dose cohorts. Accumulation was seen in the 3mg/kg TIW and 6mg/kg weekly and higher cohorts. Patients in the 3 mg/kg TIW cohort (n=8) generally maintained serum concentrations of 10 g/ml during treatment. Partial response was observed in seven patients, including two patients with the del(17p) genomic risk factor. The median reduction in absolute lymphocyte count was 73% in those patients with lymphocytosis at baseline. The responses, all partial responses, were observed in patients who had received 1 – 2 prior therapies (n=16) for an overall response rate of 44% (n=7) with a median reduction in lymphocytes of 80% in this population. No responses were observed in patients who had received prior treatment with three or more therapies (n=41), although a median reduction in lymphocytes of 54% was observed in these patients. The median reduction in lymphocytes regardless of baseline lymphocyte count or the number of prior therapies was 60%.

The most commonly reported adverse events were nausea, fatigue, diarrhea, chills, pyrexia, and neutropenia. Serious adverse events occurring in more than one patient were pneumonia, febrile neutropenia, infusion reaction, pyrexia and dyspnea. A maximum tolerated dose has not yet been reached. Additional data from all TRU-016 ASH presentations can be found at: www.truemergent.com.

About CLL

According to the Leukemia & Lymphoma Society, there are approximately 85,710 people in the U.S. living with CLL, and more than 15,000 new cases are diagnosed each year. Existing treatments for CLL have shown significant efficacy in treating indolent B-cell cancers. However, research suggests that many patients do not achieve an initial response and most eventually relapse, which suggests an acute need for differentiated treatments.

About TRU-016

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 CD20-directed therapeutics.

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, estimates of results for 2010, 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 our ability to obtain additional development funding for our product candidates; 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; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our ability to obtain sales contracts for products; 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.

SOURCE: Emergent BioSolutions Inc.

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Monday, January 3, 2011

Fuad El-Hibri has lived in all sorts of exotic locales, working for Citicorp in Saudi Arabia, consulting for Booz Allen Hamilton in Indonesia and establishing mobile telecommunications businesses in Russia, Venezuela and El Salvador.

But getting started in his current position as chief executive of Rockville-based pharmaceutical company Emergent BioSolutions took him to a far more mundane location. It was at a public auction in Lansing, Mich., in 1998 that El-Hibri offered a $25 million package of cash and commitments to privatize a government facility that was producing an anthrax vaccine.

Since then, he’s built what is now known as Emergent into a local pharmaceutical company that posted earnings of $31.1 million last year.

El-Hibri took an unusual path into the industry, spending much of his career in telecommunications. Born to a Lebanese father and German mother, he split his childhood between Lebanon and Germany before attending Stanford University. El-Hibri quickly moved on to a graduate degree, heading to Yale’s business school.

Though he wanted to start his own business, El-Hibri wanted to gain experience first. After marrying, he and his wife moved to Saudi Arabia so El-Hibri could work for Citicorp. After several years, he moved to consulting giant Booz Allen Hamilton and spent about three years in Jakarta, Indonesia. In one instance, he helped a state-owned petroleum company in Malaysia open up mini-convenience stores alongside its gas stations.

By the late 1980s, El-Hibri was ready to return to the United States, where he opened his own Potomac-based consulting firm. He quickly began working with the Moscow City Telephone Network and helped the company build and implement a mobile telecommunications network that’s still in use today. Partnering with his father — who had worked in telecommunications — El-Hibri eventually sold his interest in the firm and reinvested in a Venezuelan mobile network. He repeated the work in El Salvador.

What made El-Hibri different from other entrepreneurs was his interest in not just making money but also integrating the business into the local economy, said Brian Kim, whose company invested with El-Hibri in both his Venezuelan and El Salvadoran enterprises.

“He had a real sense that the company had [to do] something else — other than creating value for its shareholders,” Kim said. “He took a very local approach.”

Not long after, El-Hibri got involved with a business venture to sell $50 million worth of anthrax vaccine to the Saudi Arabian government, which was worried about its troops. He immediately took an interest in the field, and, after leading a management buyout of a biotechnology firm in Britain, El-Hibri set out to purchase the only facility producing a Food and Drug Administration-licensed anthrax vaccine in the United States.

He headed to Lansing, where the governor had announced the state would privatize its facility, which also had a licensed rabies vaccine, among others. El-Hibri and his partners submitted the winning bid and began renovating the facility, which was relicensed in 2001.

Emergent, which has its corporate headquarters in Rockville, soon added locations, which now extend from Seattle to Munich to Singapore. Best known for its anthrax vaccine, for which it received in July a contract worth up to $107 million, Emergent is also working on a pandemic flu vaccine and a tuberculosis vaccine.

The most recent contract, from the Department of Health and Human Services Office of the Biomedical Advanced Research and Development Authority, is meant to ready the vaccine for large-scale manufacture.

But El-Hibri doesn’t plan to end his career with pharmaceuticals and said he’d next like to work in the environmental field. (In 2001, El-Hibri launched the El-Hibri Charitable Foundation, which focuses on interfaith dialogue and peace education.)

Roberto Smith-Perera, a former minister of transport and communications in Venezuela who partnered with El-Hibri on both the Venezuelan and El Salvadoran cellular businesses, credited El-Hibri’s geographically and culturally diverse background with teaching him how to handle virtually any kind of business.

He’s the kind of person “that specializes in not . . . being a specialist,” said Smith-Perera. “He’s the ultimate project developer.”

Reprinted from the January 3, 2011 edition of  The Washington Post

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“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.

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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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“We applaud the U.S. Government’s commitment to the biodefense industry and to the development of additional medical countermeasures using multiple technologies and additional sites to address the acknowledged anthrax threat,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.  “This award solidifies Emergent’s anthrax franchise and reaffirms our position as a leading supplier to, and developer for, the U.S. government of anthrax biomedical countermeasures. We are enthusiastic about the role we serve in addressing this need and in creating jobs and expanding economies within the local communities where we operate.”

Under the contract, the base value will fund activities related to process characterization and assay validation, as well as formulation and stability studies.  Milestone-based options include completion of a Phase II clinical study and non-clinical efficacy studies, process validation, as well as consistency lot manufacture. Emergent has developed this comprehensive plan as a foundation to advance its rPA anthrax vaccine candidate in preparation for pivotal studies that would potentially lead to licensure application with the U.S. Food and Drug Administration.

The company anticipates recognizing revenues from this award in the fourth quarter of 2010 of approximately $2 million with no major impact on pretax earnings.

Emergent’s rPA anthrax vaccine candidate is a purified recombinant protective antigen protein formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins.  It is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and has been the subject of two research and development grants totaling approximately $100 million by the National Institute of Allergy and Infectious Diseases (NIAID).

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 our ability to win a procurement contract with the U.S. government for our recombinant protective antigen anthrax vaccine candidate; 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; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; 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, 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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ROCKVILLE, Md., Sep 01, 2010 –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines 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 (VaxImmuneTM).

“Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”

This four-year development contract consists of a two-year base, valued at $9.1 million, and milestone-based options that if exercised, would increase the total contract value to up to $28.7 million. The base contract will fund activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The milestone-based options include continued stability testing of Phase II clinical trial lots and a clinical study to evaluate safety and immunogenicity of the product candidate. The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.

This new contract was awarded to expand the development efforts being conducted under a Biomedical Advanced Research and Development Authority (BARDA)/NIAID contract awarded in September 2008, which provides for funding of up to $29.7 million. Thus, with this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to over $58 million.

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 .

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 June 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.

Related posts:

1. Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax ROCKVILLE, Md., — Emergent BioSolutions Inc. (NYSE:EBS) announced on June...
2. Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) — Emergent BioSolutions...
3. Emergent BioSolutions’ Investigational Anthrax Vaccine, NuThrax, Granted Fast Track Designation ROCKVILLE, Md., Jun 09, 2011 — Emergent BioSolutions Inc. (NYSE:EBS)...

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