Emergent Announces Initiation of a Phase 1b/2 Study of TRU-016 in Combination with Rituximab and Bendamustine in Subjects with Relapsed – Indolent Lymphoma
Aug/110
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
Mar/110
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 Announces Initiation of Phase Ib/II Study of TRU-016 in Combination with Bendamustine for Chronic Lymphocytic Leukemia
Feb/110
ROCKVILLE, Md., Jan 25, 2011 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.
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 52nd 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.
Emergent BioSolutions Starts Phase I Clinical Trial for Third Generation Anthrax Vaccine
Jan/110
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.
Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6 Million to Develop rPA Anthrax Vaccine
Sep/100
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
Sep/100
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 BIOSOLUTIONS ANNOUNCES THE APPOINTMENT OF DENISE LANDRY AS SENIOR VICE PRESIDENT, QUALITY
Jul/090
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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EMERGENT BIOSOLUTIONS ANNOUNCES MANAGEMENT CHANGES
Jul/090
ROCKVILLE, MD, May 16, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today the consolidation of the president and chief operating officer position. With this change, Daniel J. Abdun-Nabi, the company’s president, will also take on the role of chief operating officer. In this combined role, Mr. Abdun-Nabi will oversee all of the company’s product development, manufacturing and corporate affairs activities. Mr. Abdun-Nabi will continue to report to Fuad El-Hibri, chairman and chief executive officer of the company.
Specifics of other management changes, which are also effective immediately, include:
- R. Don Elsey is being promoted to the position of senior vice president finance and administration. Mr. Elsey was formerly vice president finance and administration. Mr. Elsey will continue to retain his responsibilities as chief financial officer for the company and will now assume additional responsibility for investor relations and human resource activities. Mr. Elsey will continue to report to Mr. El-Hibri, chairman and chief executive officer.
- Kyle W. Keese is being appointed to the position of senior vice president corporate affairs with responsibility for public affairs, marketing and sales and corporate development. Mr. Keese was formerly senior vice president marketing and communications.
- Thomas K. Zink, M.D. is assuming the responsibility for clinical development in addition to medical affairs. Dr. Zink, formerly senior vice president medical affairs, is now senior vice president medical and clinical development. Dr. Zink will continue to retain his responsibilities as chief medical officer for the company and, in that capacity, will continue to report to Mr. El-Hibri, chairman and chief executive officer.
- Edward J. Arcuri, Ph.D., is resigning his position as chief operating officer. The resignation is effective immediately.
“Today’s senior management consolidation and associated changes within our corporate organization are designed to strengthen the integration of our development and manufacturing organizations and to enhance the company’s positioning and capabilities in both the biodefense and commercial immunobiotic markets,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.
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 or 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 performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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 THAT DEPARTMENT OF HEALTH AND HUMAN SERVICES AND DEPARTMENT OF DEFENSE ISSUED NOTICES OF INTENT TO PROCURE UP TO A COMBINED 22.75 MILLION DOSES OF BIOTHRAX®(ANTHRAX VACCINE ADSORBED)
Jul/090
ROCKVILLE, MD, April 18, 2007—Emergent BioSolutions Inc. (NYSE: EBS) (EBS) today announced that the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) issued two separate notices of intent to procure up to a combined total of 22.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed).
In a Presolicitation Notice issued today, HHS stated its intent to procure 10.4 million doses of BioThrax for the Strategic National Stockpile (SNS) with options for up to an additional 8.35 million doses. HHS announced that it intends to enter sole source negotiations with the company to finalize the procurement and to make an award on or about July 24, 2007.
Separately, DoD issued a Special Notice signaling an anticipated sole source contract award to procure a minimum of 4 million doses of BioThrax, over a base period and 3 optional ordering periods.
“We were very pleased to learn of HHS and DoD’s intent to procure additional doses of BioThrax,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc. “These notices indicate a continued commitment by the U.S. Government to Emergent BioSolutions’ FDA-licensed anthrax vaccine for the protection of military personnel and civilians. We are committed to working with both HHS and DoD to promptly complete these intended procurements to ensure both federal agencies have continued access to and supply of this critical biodefense countermeasure.”
“We compliment the Government’s leadership in following a strategy of acquiring licensed available countermeasures for the highest threat agents, while pursuing next generation development utilizing new and emerging technologies,” continued Mr. El-Hibri. In support of this strategy the company has a next generation anthrax countermeasure development program which includes both BioThrax and rPA-based candidates. This program is designed to meet the next generation requirements of the Government, including: room temperature storage, extended shelf life, novel adjuvants and novel delivery systems.
Since 1998, the company has delivered 19 million doses of BioThrax under contracts with HHS and DoD.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases which pose 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, 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 company’s actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; 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 Annual Report on Form 10-K for the year ended December 31, 2006 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 Submits Proposal In Response To Hhs’ Rfp For Development And Procurement Of A Recombinant Protective Antigen Anthrax Vaccine
Jul/090
The company’s submission provides the U.S. Government with the critical option to select a domestic source to meet planned procurement of 25 million doses of rPA vaccine.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has submitted a proposal in response to a request for proposal (RFP) issued by the U.S. Department of Health and Human Services (HHS) for a recombinant protective antigen anthrax vaccine (rPA). Emergent’s rPA vaccine candidate, which has completed one Phase II clinical trial, is a reformulated and more stable form of the rPA 102 vaccine originally developed at USAMRIID and is well positioned to be a leading candidate for an award under this RFP.
This RFP is designed to meet the government’s stated goal to procure 25 million doses of an rPA anthrax vaccine for the Strategic National Stockpile (SNS). This contract would be in addition to the $448 million three-year contract awarded to Emergent in 2007 that includes the supply of 18.75M doses of its FDA licensed anthrax vaccine BioThrax to the SNS. In the event that Emergent receives an award under the rPA RFP, doses of rPA procured by HHS would be in addition to the 18.75 million doses of BioThrax being procured by HHS pursuant to the three-year contract. HHS has indicated that any awards under the rPA RFP would be granted at the end of 2008, at the earliest.
“We are very pleased with our submission in response to this RFP and we are confident that our rPA 102 vaccine is a leading candidate to be selected as an advanced rPA anthrax vaccine. Our company is proud of our proven track record of delivering critical biodefense countermeasures to the U.S. government and we believe our reputation as the premiere domestic biodefense supplier, coupled with our development and manufacturing expertise, uniquely situates Emergent to meet HHS’s stated commitment to procure 25 million doses of a recombinant anthrax vaccine for the Strategic National Stockpile,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.
“Considerable effort and resource have been directed toward improving the stability of the rPA 102 vaccine. Analytical testing as well as animal immunogenicity and efficacy studies indicate the stability of our recombinant protective antigen vaccine candidate has been significantly improved. We are confident that the new, enhanced vaccine formulation will address any stability concerns HHS may have had in the past. The current formulation, we believe, will meet and most likely exceed BARDA stability requirements for an rPA vaccine,” said Dr. James Jackson, senior vice president and chief scientific officer of Emergent BioSolutions.
The company intends to manufacture this rPA anthrax vaccine, as well as BioThrax, in its recently constructed, large-scale manufacturing facility at its Lansing campus. The continued development of this rPA vaccine candidate further solidifies Emergent’s well established franchise of anthrax countermeasures, which now includes:
BioThrax® (Anthrax Vaccine Adsorbed) is the only FDA-approved vaccine to prevent the infection of anthrax. Nearly 2.0 million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;
rPA 102, a recombinant anthrax vaccine candidate, which is composed of a purified protein with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins;
AVP-21D9, a human monoclonal antibody product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease; and
AIG, a polyclonal anthrax immune globulin product candidate being developed as an intravenous post-exposure treatment for patients who present symptoms of anthrax disease, is derived from human plasma from individuals who have been vaccinated with BioThrax.
About rPA 102
The vaccine candidate, rPA 102, is based on a recombinant form of the protective antigen protein. This vaccine contains a purified protein (rPA) formulated with an alum adjuvant and is designed to induce antibodies that neutralize anthrax toxins. The vaccine candidate does not cause anthrax infection and is based on the pioneering work of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). rPA 102 has been the subject of two research and development grants totaling approximately $100 million from the National Institute for Allergy and Infectious Diseases (NIAID).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading, multinational biopharmaceutical company dedicated to one simple mission — to protect life. Emergent develops, manufactures and commercializes immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. The company’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. 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 2008, 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 sales contracts for BioThrax®, rPA 102, AVP-21D9 and AIG with the U.S. government; our plans for future sales of BioThrax, rPA 102, AVP-21D9 and AIG; 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; 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 March 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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