Fuad El-Hibri and the International Biomedical Research Alliance
Nov/100
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
Oct/100
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
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 Revises Upward 2010 Financial Forecast
Aug/100
Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million
ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million. Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010. This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate.
The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax® procurement contract with the US Centers for Disease Control and Prevention (CDC). This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010. This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010.
“This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent. “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.”
Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility. We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
About BioThrax®
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 45 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Fuad El-Hibri on Corridor Inc.
Aug/090
Fuad El-Hibri, chairman and chief executive officer at Emergent BioSolutions Inc., is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region. The awards program recognizes extraordinary innovation, financial performance and personal commitment to a businesses and its community. Emergent BioSolutions, based in Rockville, is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics.



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