Archive for category Anthrax vaccines
Emergent BioSolutions Starts Phase I Clinical Trial for Third Generation Anthrax Vaccine
Posted by admin in Anthrax vaccines, Biothrax, Chief executive officer, El-Hibri, Emergent BioSolutions, Food and Drug Administration, fuad on January 5th, 2011
ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. The product candidate, a third generation vaccine being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909.
“Emergent is pleased to commence this clinical trial in support of the U.S. government’s multiple product strategy to strengthen the nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe this third generation anthrax vaccine has the potential to exhibit advanced characteristics such as requiring fewer doses, generating an enhanced immune response, and having a favorable shelf life. If successful, this could be an attractive candidate for the government’s growing arsenal of medical countermeasures.”
The Phase I clinical trial, a parallel arm dose-ranging study, is designed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidate. The study is being conducted in multiple sites within the U.S. and involves 105 healthy volunteers. Preliminary data from this study is expected to be available in the third quarter of 2011.
This Phase I trial is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE: Emergent BioSolutions Inc.
Fuad El-Hibri and the International Biomedical Research Alliance
Posted by admin in Anthrax, Anthrax vaccines, Biothrax, Chief executive officer, Emergent BioSolutions, Food and Drug Administration, Research and development, U.S. Food and Drug Administration, fuad el-hibri on November 13th, 2010
The International Biomedical Research Alliance (IBRA) is a philanthropic organization that is dedicated to the support of the NIH-Oxford-Cambridge Scholars Program, which strives to establish the highest standards of excellence in training biomedical researchers, advance groundbreaking biomedical research, enrich the pool of leaders in the field, and eliminate barriers which frustrate the transfer of a broad spectrum of knowledge to the next generation of researchers.
Along with colleagues from industry, education, and government, Fuad El-Hibri is a member of the IBRA Board of Directors. The Alliance helps provide opportunities for students to build and develop important elements of scientific leadership, giving students the opportunity to grow into exceptional biomedical research leaders. IBRA firmly believes in the ability of outstanding researchers to transform today’s promise of cures and treatments into available therapies, drugs and prevention measures that enhance the world’s health.
Since its inception in 2000, the Scholars program has recruited gifted, inquiring, creative and dedicated minds for a uniquely designed doctoral program of training and investigative, exploration to challenges some of the worlds greatest minds to achieve IBRA’s main goal to create the premier PhD and MD/PhD program.
Emergent BioSolutions to Release Third Quarter 2010 Financial Results and Conduct a Conference Call on November 4, 2010
Posted by admin in Anthrax, Anthrax vaccines, Chief executive officer, Emergent BioSolutions, fuad el-hibri on October 23rd, 2010
ROCKVILLE, Md., Oct 13, 2010 — Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for third quarter 2010 on Thursday November 4, 2010, after market close. Company management will host a conference call at 5:00 pm Eastern on November 4, 2010 to discuss the financial results for the third quarter and first nine months of 2010, recent business developments and the forecast for 2010. The conference call will be accessible by dialing 888/713-4211 or 617/213-4864 (international) and providing passcode 50859780. A webcast of the conference call will be accessible from the Company’s website at www.emergentbiosolutions.com, under “Investors”.
Emergent BioSolutions is offering call participants a pre-registration option that expedites access to the call and minimizes hold times. Pre-registrants will be issued a pin number to be used when dialing into the live call which will provide quick access to the conference call by bypassing the operator upon connection. Pre-registration, while not mandatory, can be accessed using the following website: https://www.theconferencingservice.com/prereg/key.process?key=PNP49E4W7.
A replay of the conference call will be accessible, approximately one hour following the conclusion of the call, by dialing 888/286-8010 or 617/801-6888 and using the passcode 97521313. The replay will be available through November 18. The webcast will be archived on the company’s website, www.emergentbiosolutions.com, under “Investors”.
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 disease. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
Emergent BioSolutions Awarded HHS Contract Valued at up to $186.6 Million to Develop rPA Anthrax Vaccine
Posted by admin in Anthrax vaccines, Biothrax, Chief executive officer, Emergent BioSolutions, Food and Drug Administration, Research and development, U.S. Food and Drug Administration, fuad el-hibri on September 20th, 2010
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 Hosts Symposium for Biomedical Research Scholars
Posted by admin in Anthrax vaccines, Chief executive officer, Emergent BioSolutions, Infectious disease, Scholars Program, fuad el-hibri on August 30th, 2010
ROCKVILLE, Md., Aug 24, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today hosted “Looking Beyond the Bench,” a symposium organized for doctoral students enrolled in the NIH-Oxford-Cambridge Scholars Program. The symposium featured Emergent executives, who, based on their extensive experience in the biopharmaceutical industry, provided insight on potential career paths awaiting biomedical researchers. The speakers highlighted examples of how a scientific background would interrelate with such disciplines as Grants and Contracts, Clinical Development, Intellectual Property, and Product Development.
The NIH-Oxford-Cambridge Scholars Program (Scholars Program) was created in 2001 to revolutionize the way in which the most talented biomedical PhD and MD/PhD students are trained. Every pedagogical and logistical element of the Scholars Program was designed to produce scientists who will generate high-impact, breakthrough results at the speed at which science, government and industry must move to meet the demanding healthcare needs of a global population. The Scholars Program trains more “prestige” scholars (Rhodes, Marshall, Churchill, Gates, Howard Hughes Medical, Fulbright, and Goldwater) than any other program in the world. To date, the Scholars Program has produced 45 doctoral graduates and currently has 113 scholars enrolled.
“Emergent is pleased to welcome the future leaders in scientific research and discovery, who are already engaged in and contributing to public health improvement by exhibiting academic excellence,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions and member of the Alliance Board of Trustees. “We congratulate them for their exceptional talent, which brought them to the scholars program and which will guide them to its completion.”
“The Alliance is most grateful for Mr. El-Hibri’s private sector perspectives which have helped to shape the values, culture, goals and metrics of success of the Scholars Program,” said Ann Marie Drucker, Alliance President.
Over 35 scholars participated in the symposium and laboratory tour that was held at Emergent’s product development facility in Gaithersburg, Maryland.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
About the International Biomedical Research Alliance
The International Biomedical Research Alliance (Alliance) was created in 2005 as a private, not-for-profit (501(c)(3) providing expertise and resources to assure the NIH-Oxford-Cambridge Scholars Program’s financial viability and unwavering adherence to absolute standards of excellence, continuous innovation and dedication to accelerated discovery for generations to come. In pursuit of its mission, the Alliance provides philanthropic, scientific and industry resources dedicated to developing the NIH-Oxford-Cambridge Scholars Program into the pre-eminent biomedical training pathway for leaders in the life sciences.
