Archive for the ‘Research and development’ Category

Emergent Announces Initiation of a Phase 1b/2 Study of TRU-016 in Combination with Rituximab and Bendamustine in Subjects with Relapsed – Indolent Lymphoma

ROCKVILLE, Md., Aug 17, 2011 –

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.

 

Delegates from European Parliament Express Support for Rapid Development of New TB Vaccine

Comments expressed during tour of South African clinical trial site where Emergent’s TB vaccine candidate is expected to complete enrollment in April for its Phase IIb efficacy study

ROCKVILLE, Md., Feb 25, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that a joint delegation of Members of the European Parliament (MEPs) and representatives from the Oxford-Emergent Tuberculosis Consortium (OETC) today visited the trial site where MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine candidate in development, is being studied in a Phase IIb infant efficacy clinical trial. This clinical trial in Worcester, South Africa is being conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI), in partnership with OETC and Aeras.

“I am very anxious to see a new TB vaccine licensed and I am delighted that this trial of this promising new vaccine candidate is taking place,” said MEP Michael Cashman, Chairman of the South Africa Delegation of the European Parliament. “It is vital for South Africa that a new vaccine is developed as soon as possible, especially for infants and those with HIV. If this trial is successful, South Africa will benefit and so will the rest of the world. Too many lives are lost to tuberculosis and I am pleased to see so many public and private bodies coming together to deliver what could be the first new TB vaccine in 90 years.”

Emergent BioSolutions is proud to be part of OETC, a joint venture established with the University of Oxford in 2008, to further develop the most clinically advanced investigational TB vaccine,” said Allen Shofe, OETC Board Member and Senior Vice President Corporate Affairs of Emergent BioSolutions. “This collaboration is an integral part of a multi-pronged approach to alleviating the global burden of tuberculosis. Through our involvement in OETC, Emergent is given an opportunity to touch the lives of many in fulfillment of our company mission – to protect life.”

The MEPs learned firsthand about the TB vaccine candidate and progress of the clinical trial from lead scientist and developer Dr. Helen McShane from the University of Oxford. “We are extremely pleased with the progress of the trial,” said Dr. McShane. “We anticipate that the trial, which involves administering MVA85A as a booster to the BCG vaccine, will reach the enrollment target of 2,784 infants by the end of April 2011. The follow-up period and study results are expected to be completed in 2012.”

The delegation also observed the vaccination of infants as part of the trial and visited the hospital facilities with Dr. Hassan Mahomed, SATVI’s Principal Investigator on the study.

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, 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 actual results of the Consortium or Emergent to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from, future product development efforts; the ability of the Consortium or Emergent to obtain additional funding for product development efforts; plans of the Consortium and Emergent to expand manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of products; and other factors identified in Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 and subsequent reports filed with the SEC. The Consortium and Emergent disclaim 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.

 

CEO took roundabout path to Emergent

By Marjorie Censer

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

 

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

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 and the International Biomedical Research Alliance

The International Biomedical Research Alliance (IBRA) is a philanthropic organization that is dedicated to the support of the NIH-Oxford-Cambridge Scholars Program, which strives to establish the highest standards of excellence in training biomedical researchers, advance groundbreaking biomedical research, enrich the pool of leaders in the field, and eliminate barriers which frustrate the transfer of a broad spectrum of knowledge to the next generation of researchers.

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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Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6 Million to Develop rPA Anthrax Vaccine

ROCKVILLE, MD, September 17, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract, valued at up to $186.6 million, with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the development of a recombinant protective antigen (rPA) anthrax vaccine.  This five year cost plus fixed fee development contract consists of a two-year base period of performance valued at approximately $51 million, three successive one-year option periods valued at approximately $126 million and funding for optional non-clinical studies valued at approximately $9 million.

“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.

 

Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine

New Contract Valued at up to $28.7 Million for Phase II Clinical Trial

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.

 

Emergent Revises Upward 2010 Financial Forecast

Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million

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

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

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

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

About Emergent BioSolutions Inc.

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

About BioThrax®

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

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

 

Emergent BioSolutions Recognized as Biotechnology Firm of the Year by Tech Council of Maryland

ROCKVILLE, MD, May 13, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland’s (TCM) Annual Tech Awards.  This award acknowledges the company that best exemplifies the spirit of Maryland’s biotechnology community as well as its presence and leadership within the state.

“It is an honor to represent Emergent BioSolutions, a company composed of talented and hardworking individuals committed to the corporate mission of protecting life,” said Fuad El-Hibri, chairman and chief executive officer, who received the award on behalf of the company.

For 22 years, TCM has recognized companies that have helped establish Maryland’s thriving technology community.  This year’s theme “Building Something Great Together” focuses on the tremendous growth and future outlook for the technology community.

Fuad El-Hibri Accepts the 2010 Tech Council of Maryland Biotechnology Firm of the Year Award

Fuad El-Hibri Accepts the 2010 Tech Council of Maryland Biotechnology Firm of the Year Award

“The theme, ‘Building Something Great Together,’ is meaningful because Emergent’s success is built on teamwork and collaboration,” Mr. El-Hibri continued.  “It also acknowledges the role that businesses play in contributing to the State’s economic and job growth.  Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.”

The criteria for the Biotechnology Firm of the Year Award include: achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, crisply executing a growth strategy, and helping foster a vibrant biotech community.

TCM is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM’s mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapeutics 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 disease.  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