Posts Tagged Research and development
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 Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine
Posted by admin in Anthrax, Biothrax, Chief executive officer, Emergent BioSolutions, Food and Drug Administration, fuad el-hibri on September 10th, 2010
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 Recognized as Biotechnology Firm of the Year by Tech Council of Maryland
Posted by admin in Chief executive officer, Emergent BioSolutions, Food and Drug Administration, Research and development, Tech Council of Maryland, U.S. Food and Drug Administration, fuad el-hibri on May 18th, 2010
ROCKVILLE, MD, May 13, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland’s (TCM) Annual Tech Awards. This award acknowledges the company that best exemplifies the spirit of Maryland’s biotechnology community as well as its presence and leadership within the state.
“It is an honor to represent Emergent BioSolutions, a company composed of talented and hardworking individuals committed to the corporate mission of protecting life,” said Fuad El-Hibri, chairman and chief executive officer, who received the award on behalf of the company.
For 22 years, TCM has recognized companies that have helped establish Maryland’s thriving technology community. This year’s theme “Building Something Great Together” focuses on the tremendous growth and future outlook for the technology community.
“The theme, ‘Building Something Great Together,’ is meaningful because Emergent’s success is built on teamwork and collaboration,” Mr. El-Hibri continued. “It also acknowledges the role that businesses play in contributing to the State’s economic and job growth. Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.”

Fuad El-Hibri Accepts the 2010 Tech Council of Maryland Biotechnology Firm of the Year Award
The criteria for the Biotechnology Firm of the Year Award include: achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, crisply executing a growth strategy, and helping foster a vibrant biotech community.
TCM is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM’s mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com
Emergent Biosolutions And Ninebio Sdn. Bhd. Announce Joint Venture In Malaysia
Posted by admin in Uncategorized on July 11th, 2009
Newly formed company to focus on creating critical R&D and manufacturing infrastructure and supplying biodefense countermeasures within Asia and other territories.
January 24, 2008 – Emergent BioSolutions (NYSE: EBS) and Ninebio Sdn. Bhd. (“9Bio”) today announced the formation of a joint venture in Malaysia that will focus on creating critical biologics infrastructure and supplying biodefense countermeasures, including BioThrax® (Anthrax Vaccine Adsorbed), and other medical and complementary products and services to the Government of Malaysia. It is anticipated that the joint venture will also supply such products and services to certain member countries of the Organisation of the Islamic Conference (“OIC”) and other countries within Asia. 9Bio is a Malaysian Government owned company and one of the National Institutes of Health under the Ministry of Health. 9Bio is fully funded by the Government of Malaysia. The Government of Malaysia, through 9Bio, has selected Emergent BioSolutions as one of its principal partners to assist, as a contract service provider, in building vaccine development and manufacturing infrastructure. The joint venture will be majority owned by Emergent BioSolutions.
“This joint venture is a step towards our objective to obtain vaccine development and manufacturing capabilities as well as bio-terrorism preparedness. I am very proud that 9Bio has been entrusted to serve as an extension of the Malaysian Government’s implementation of these critical objectives. Emergent BioSolutions is the most appropriate partner for 9Bio for this venture and I am confident that the new company will exemplify both expertise and experience in this area,” said chief executive officer of 9Bio, Datuk Dr. Nor Shahidah Khairullah. “We are looking forward to working very closely with the Ministry of Health and other agencies in Malaysia in developing and implementing this plan.”
“We are honored to partner with 9Bio for this important joint venture and to have been selected by the Government of Malaysia to provide these important services. It is our belief that this joint venture will not only expand the use of our anthrax vaccine in this market, but will also serve as a platform for joint product development and manufacturing activities,” said Fuad El–Hibri, chairman and chief executive officer of Emergent BioSolutions. “Emergent BioSolutions applauds the Malaysian Government’s support of a public-private partnership approach to growing the Malaysia biotechnology sector and we welcome the opportunity to play a pivotal role in the implementation of its plan.”
Witnessing the signing ceremony, Director General of the Malaysian Ministry of Health, Tan Sri Datuk Dr Haji Ismail Merican affirmed that through 9Bio, one of the National Institutes of Health in Malaysia, the Ministry of Health would be able to focus on developing and manufacturing biologics, biosecurity and bioterrorism countermeasures for Malaysia.
About Ninebio
Ninebio Sdn. Bhd. is a Malaysian Government owned company, and as one of the National Institutes of Health, under the Ministry of Health, is focused on the research and development of vaccines, natural products and biologics. Its vision is to “drive innovation solutions for a healthier world.” One of the focus areas of development is in biosecurity and bioterrorism counter-measures. 9Bio is currently cementing strategic alliances with companies that meet its needs. 9Bio is constructing its research and development and secondary manufacturing facility in Bandar Enstek, Negeri Sembilan, Malaysia. It is expected to be completed by 2010. Pending the completion of its facilities, 9Bio intends to procure and distribute vaccines, natural products and biologicals to customers in the ASEAN region thereby building its brand name. 9Bio is primarily funded by the Government of Malaysia.
About Emergent BioSolutions Inc
Emergent BioSolutions Inc is a profitable, multinational 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 and other medical conditions that have resulted in significant unmet or under deserved public health needs. Our marketed product, BioThrax® (Anthrax Vaccine Absorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.
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, prospects, plans and objectives of management, including development plans, 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 actual results to differ materially from those indicated by such forward-looking statements, including the rate and degree of market acceptance and clinical utility of products; ability to identify and acquire or in license products and product candidates that satisfy 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 Emergent’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and subsequent reports filed with the SEC. Emergent 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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