Archive for the ‘Clinical Study’ 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.

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Oxford-Emergent Tuberculosis Consortium Vaccinates Last Infant in Phase IIb Clinical Trial

  • Total of 2,784 infants vaccinated in TB efficacy trial evaluating MVA85A
  • Study results expected to be available as early as mid-2012

ROCKVILLE, Md., Apr 28, 2011

Emergent BioSolutions Inc. (NYSE:EBS) announced today that its joint venture with the University of Oxford (Oxford), the Oxford-Emergent Tuberculosis Consortium (OETC), has vaccinated the last of the 2,784 infants in its Phase IIb efficacy trial evaluating MVA85A, the world’s most clinically advanced tuberculosis (TB) vaccine in development. 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 Aeras, the clinical sponsor of the study, and the Wellcome Trust.

“Emergent BioSolutions joined the fight against TB when it formed OETC with Oxford to further develop MVA85A,” said Daniel J. Abdun-Nabi, Chairman of the Board, OETC and President and Chief Operating Officer, Emergent BioSolutions. “We are pleased to complete the vaccination of our targeted 2,784 infants, which is the largest number of infants enrolled in any TB vaccine clinical trial. Our quest to fulfill Emergent’s corporate mission – to protect life – will come to fruition when we can bring this vaccine candidate to market and ultimately make an impact in patients’ lives.”

“We are extremely proud of this achievement and are eager to see the study results, which are expected to be available as early as mid-2012,” said Dr. Helen McShane, lead scientist and developer of MVA85A from the University of Oxford. “This milestone brings us a step closer to potentially having a new TB vaccine, from which millions of people around the world would benefit.”

This Phase IIb clinical trial was initiated in July 2009 and involves a two-year follow up on the infants vaccinated as part of the trial to evaluate whether the vaccine candidate has conferred protection against TB.

About Emergent BioSolutions Inc.

Emergent BioSolutions, led by Chairman &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 strategy, future operations, future financial position, future revenues, projected costs, future product development, 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 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 Annual Report for the year ended December 31, 2010 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.

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.

Emergent BioSolutions Buys Rival Vaccine for $2 Million

Lansing-based Emergent BioSolutions picked up its U.S. rival’s anthrax vaccination technology for $2 million, strengthening the company’s ability to make a second anthrax vaccination.

According to excerpts from the article:

In Lansing, the acquisition of VaxGen Inc.’s vaccine could add a second product line at a new plant.

Based in Rockville, Md., Emergent currently makes the BioThrax vaccine in Lansing.

The U.S. Department of Health and Human Services is expected to seek 25 million doses of such a vaccine later this year, Emergent said.

“We felt this was the right opportunity for our company at the right time,” Emergent Chairman and Chief Executive Officer Fuad El-Hibri said in the company’s announcement.

EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC

$9.5 million development contract to fund non-clinical and clinical studies of anthrax immune globulin (AIG) over next 24 months

ROCKVILLE, MD., September 27, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has received a development contract, valued at up to $9.5 million, in support of non-clinical and clinical studies of the company’s anthrax therapeutic, or AIG, product candidate.  This product candidate is an immune globulin being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease following exposure to anthrax.

This development contract has been funded in whole or in part from Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS), under Contract No. HHSN272200700034C.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “We are very pleased to have continuing support for AIG from NIAID and BARDA and commend the leadership throughout HHS for their commitment to funding the development of effective medical countermeasures against this deadly biological agent.  With the continued development funding of our AIG candidate, in conjunction with the $448 million contract with HHS announced yesterday regarding procurement of 18.75 million doses of our BioThrax anthrax vaccine for the strategic national stockpile, we are very encouraged by the government’s support of our anthrax franchise.  We look forward to continuing to be a leading participant in the U.S. government’s effort to build a robust domestic biodefense industry.”

Under terms of the development award, the funds will be used to conduct various studies on AIG, including (i) non-clinical studies in support of efficacy; and (ii) a Phase I/II clinical study to evaluate pharmacokinetics and safety.  Previously, in August 2006 the company received $3.9 million from NIAID in support of the company’s AIG program.  When combined with the $9.5 million under this new development award, the total amount of government funding for AIG to date is over $13 million.

About Anthrax Immune Globulin (AIG)

Emergent BioSolutions’ anthrax immune globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body and for whom the use of the vaccine is no longer an effective option.  If successfully developed, AIG could be prescribed for administration in these circumstances either as a monotherapy or in conjunction with an antibiotic.

AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), Emergent BioSolutions’ anthrax vaccine, which is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

The company has collected a sufficient amount of plasma to initiate manufacturing of AIG under cGMP using a validated and approved process.  This manufacturing process entails fractionating the plasma and purifying the immune globulin.  The company has signed an exclusive license with Talecris Biotherapeutics, Inc., a North Carolina-based biopharmaceutical company and leading fractionation provider, to fractionate, purify and fill AIG at Talecris’ FDA-approved facilities.  To date, the first full-scale lot of AIG has been manufactured under cGMP requirements at Talecris.  The company has scheduled plans to complete a second full-scale lot of AIG.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our 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.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available 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 our performance under our contract with HHS and future payments from HHS to us under the contract, 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 plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; 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, 2007 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 Announces the Appointment of Denise Landry as Senior Vice President , Quality

ROCKVILLE, MD, October 9, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Ms. Denise Landry has joined the company as Senior Vice President, Quality with responsibility for managing and overseeing all Quality activities company-wide.  Ms. Landry has broad-based quality experience for pharmaceutical and biologics operations, including activities relating to all phases of product development, regulatory submissions, and compliance programs.  In addition, Mrs. Landry has extensive experience interacting with regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Medicines and Healthcare Product Regulatory Agency (MHRA) in the United Kingdom.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions stated “I am pleased to welcome Ms. Denise Landry to Emergent BioSolutions as Senior Vice-President, Quality.  Her two decades of experience in the Quality programs will be a critical asset to our team.  Denise’s first-hand experience and breadth of knowledge make her uniquely qualified for such an important role in our company.”

Ms. Landry joins the company from MGI Pharma Inc. and its predecessor Guilford Pharmaceuticals, where she served as Vice President, Corporate Quality.  Prior to her 13 year tenure there, Ms. Landry was the Director Quality Assurance for Pharmaceutical Systems, Inc. and Quality Assurance Director for Smith & Nephew Solopak.  She began her career in the quality control field as a Service Quality Manager for Baxter Healthcare Corporation.

“I am very pleased to be joining the management team at Emergent BioSolutions, and I share their commitment to maintaining the highest quality standards in manufacturing and product development,” said Ms. Denise Landry.  “I have dedicated my career to this industry and look forward to leading and promoting continuous quality improvement throughout the company as it develops and manufactures products to protect life.”

Mrs. Landry holds a BA in Biology from Fisk University in Tennessee.  She is a member of the American Society of Quality Control and the Parenteral Drug Association.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our 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.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available 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 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 execution of our strategy by our executive team; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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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HHS Requires Bidders in Competitive Range for Recombinant Anthrax Vaccine (rPA) Contract to Submit Development Plan to FDA for Review

ROCKVILLE, Md.-(Business Wire)-April 16, 2009 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that late on April 15th, HHS requested that each bidder in the competitive range for the rPA contract submit its product development plans to FDA for review in advance of an award. Emergent had already requested and is presently scheduling a meeting with the FDA as part of its pre-award activity. The Company intends to incorporate any FDA comments into its rPA development plan. Emergent will continue to move its rPA program forward to position the company to execute on the anticipated contract, once awarded.

“We strongly support this step by HHS, which potentially reduces development risk for our rPA vaccine candidate. We remain confident that we are well-positioned and competitive to receive any award granted by HHS for the development and procurement of the rPA vaccine. We look forward to continuing our long-standing relationship with the US Government as the proven and preeminent supplier of medical countermeasures to protect our nation,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

As with any government solicitation of this size and scope, there are no assurances that HHS will not impose additional requirements, which may further extend contract negotiations.

This action has no impact on the company’s existing contracts with HHS to supply BioThrax®, the only FDA licensed anthrax vaccine, for the Strategic National Stockpile (SNS). This year Emergent is completing the delivery of 18.75 million doses of BioThrax for inclusion in the SNS. Also this year, following the completion of that delivery, Emergent will begin to supply HHS with an additional 14.5 million doses of BioThrax under a follow-on contract. The total value of these two procurement contracts with HHS for BioThrax exceeds $800 million.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and 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 licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B 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, 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 clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 annual report on Form 10-K for the year ended December 31, 2008 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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EMERGENT BIOSOLUTIONS ANNOUNCES DR. STEPHEN LOCKHART JOINS COMPANY TO LEAD COMMERCIAL PRODUCT DEVELOPMENT SUBSIDIARY

Dr. Lockhart Brings Top-Tier Pharma Leadership to Development of Company’s Commercial Product Portfolio

ROCKVILLE, MD, October 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that Dr. Stephen Lockhart has been appointed President, Emergent Product Development UK.  Dr. Lockhart will be based at the company’s office located in Wokingham, England, and his responsibilities will include providing oversight, leadership, direction and execution of development programs in both the United Kingdom and Germany.  These programs include, among others, the following product candidates: a single-dose oral typhoid vaccine that recently completed a Phase II clinical trial; a drinkable Hepatitis B therapeutic vaccine in a Phase II clinical trial; and a group B streptococcal vaccine candidate that completed a Phase I clinical study and for which further clinical studies are being planned in collaboration with the National Institute of Allergy and Infectious Diseases.

“It is with great pleasure that I welcome Dr. Lockhart to the company,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.  “We are very fortunate to have someone at the helm of our commercial product development efforts with such broad and varied expertise in vaccinology, as well as an intimate understanding of the critical elements involved in the biopharmaceutical industry.  His experience in bringing vaccines through clinical development and regulatory approval makes him ideally suited to lead our commercial product development programs.”

Dr. Lockhart has over fifteen years of experience in vaccine development and most recently was Assistant Vice President and Global Head of Bacterial Vaccine Clinical R&D at Wyeth.  Prior to joining Wyeth in 1990, Dr. Lockhart served as a Medical Adviser with Janssen Pharmaceutical from 1986-1989.

“I am pleased to be joining Emergent BioSolutions and am particularly excited about leading product development for such a diverse portfolio,” said Dr. Lockhart.  “The success of our efforts will potentially help millions of people and I am eager to apply my years of experience towards this exciting portfolio and the mission of the company,” he continued.

Dr. Lockhart is an internationally recognized leader in vaccine-related product development and has been the recipient of multiple awards.  He accepted the Prix Galien, a renowned award given for excellence in pharmaceutical innovation, on behalf of Wyeth in both 2000 and 2005 and received the Wyeth Research President’s Award in 2000 for leading the development of Meningitec, a meningitis C vaccine.

Dr. Lockhart has an MA from Cambridge University and received his advanced medical and research degrees from Oxford University.  In 1983 he became a Member of the Royal College of Physicians and in 1988 received his Diploma in Pharmaceutical Medicine.  After becoming a Member for the Faculty of Pharmaceutical Medicine in 1991, Dr. Lockhart was inducted as a Fellow of the Faculty of Pharmaceutical Medicine in 2003.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our 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.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available 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 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 execution of our strategy by our executive team; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES REMAINS COMMITTED TO PROCUREMENT OF BIOTHRAX® UNDER CURRENT CONTRACT

ROCKVILLE, MD, November 19, 2007 —Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Department of Health and Human Services (HHS) has reaffirmed its commitment to continue to purchase BioThrax® (Anthrax Vaccine Adsorbed) under the current contract for 18.75 million doses that provides for a firm fixed price of $400 million plus an additional $34 million upon receipt of regulatory approval of four year dating.  In a recent notification, HHS stated the following:

  • HHS plans to continue purchasing BioThrax under the contract, which is for 18.75 million doses; and
  • HHS is diligently working with the Department of Defense (DOD) and other federal partners, as required by Homeland Security Presidential Directive 21 and recommended by a recent Government Accountability Office report, to address effective stockpile management to meet collective requirements.

“We are pleased that HHS has reaffirmed its commitment to the continued procurement of BioThrax under our recent contract, and we are confident that BioThrax will remain a critical component of our nation’s preparedness efforts,” said Fuad El-Hibri, Chief Executive Officer and Chairman of Emergent BioSolutions.  “Emergent BioSolutions looks forward to continuing our long standing relationship with the U.S. government to protect our military men and women as well as Americans at home.”

In the last few months, the company announced significant progress in achieving its business objectives including:

  • the upward revision to its revenue guidance to reflect 2007 full-year revenue growth of between 16% and 18%, and a continued commitment to profitability in 2007, which will represent the sixth consecutive year of full year profitability;
  • the signing of a $448 million three-year contract with the HHS that included $400 million for delivery of 18.75 million doses of BioThrax, $34 million upon receipt of regulatory approval of four year dating, and $11.5 million in connection with a post-exposure indication for BioThrax;
  • the completion of the first delivery of BioThrax to HHS under the new contract, which generated revenue of approximately $42 million;
  • the completion of a clinical study in support of the post exposure prophylaxis indication for BioThrax, which triggered an $8.8 million milestone payment from HHS;
  • the receipt of a $9.5 million award from HHS to fund the continued development of the company’s anthrax immune globulin therapeutic candidate; and
  • the positive completion of a double-blind, placebo-controlled Phase II clinical trial of its single-dose, oral typhoid vaccine candidate in a pediatric population, with the vaccine being well-tolerated and immunogenic.

“These developments demonstrate consistent progress during 2007 towards expanding our business and achieving long-term growth,” he continued. “The HHS contract provides us with a baseline of revenue sufficient to support the growth and profitability of our company in 2008 and 2009, and we intend to expand our revenue sources, including with the Department of Defense, other domestic customers, and internationally with foreign governments based on projects we have been actively pursuing while remaining fiscally responsible in the management of our operations.  Emergent BioSolutions remains focused on building upon our past success and further expanding our presence as an innovative biopharmaceutical company with a simple mission – to protect life.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission – to protect life.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our 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.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available 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 our expected revenue growth and net earnings for 2007, 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 new BioThrax® sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; 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, 2007 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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