Fuad El-Hibri Org

ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical trial for NuThrax^TM (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.

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.

Board expands with Election of Fuad El-Hibri,
Margaret A. Hamburg, MD, and James M. Phillips

WASHINGTON— September 3, 2007.  NHM Chairman Louis Sullivan, MD, has announced the election of biotechnology executive Fuad El-Hibri, physician and public health expert Margaret A. Hamburg, MD, and technology entrepreneur James M. Philips to the NHM Board of Trustees for three-year terms of service.

Fuad El-Hibri	Margaret Hamburg	James Philips

“As we continue working toward our goal of an institution that will serve as a global information platform, we celebrate the election of three new board members who have each made key contributions to the creation of a healthier and safer world,” said Sullivan.

“Through his leadership in the field of biotechnology, Fuad El-Hibri is helping develop strategies to address serious threats to global health security.  Throughout a distinguished career in public service, Peggy Hamburg has focused her considerable intellect and medical training on similar concerns as well as a range of other pressing health policy issues.  And from his position at the vanguard of the information technology revolution, Jim Phillips has helped successfully launch companies and institutions that are improving our ability to connect, communicate and heal.

“We are proud to have earned the active interest and support of Fuad, Peggy and Jim and look forward to drawing extensively upon their experience and expertise as our efforts to develop NHM proceed,” said Sullivan.

Fuad El-Hibri, CEO and Chairman, Emergent Biosolutions

Fuad El-Hibri leads Emergent Biosolutions, a Maryland-based biotechnology company focused on the development, manufacture and commercialization of immunobiotics.  The company operates in two business segments: biodefense and commercial. In its biodefense business, Emergent develops and commercializes immunobiotics for use against biological agents that are potential weapons of bioterrorism. In its commercial business, the company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs.

El-Hibri served as chief executive officer and chairman of the board of directors of BioPort Corporation from 1998 until 2004, when BioPort became a subsidiary of Emergent.  He also served as chairman of Digicel Holdings, Ltd., a privately held cellular telecommunications firm, from August 2000 to October 2006.  Since 1990, he has also served as chairman of East West Resources Corporation, a venture capital and financial consulting firm.

He is a member of the board of trustees of American University and a member of the board of directors of the International Biomedical Research Alliance, an academic joint venture among NIH, Oxford University and Cambridge University. He also serves as chairman and treasurer of El-Hibri Charitable Foundation which has contributed to a variety of international development projects, including a children’s orphanage in Lebanon.  He holds a master’s degree in public and private management from Yale University and a B.A. in economics from Stanford University.

Margaret A. Hamburg, MD, Senior Scientist, Global Health and Security Initiative, NTI

One of the youngest people ever elected to the Institute of Medicine of the National Academy of Sciences, Dr. Margaret “Peggy” Hamburg is a highly regarded expert in community health and bio-defense, including preparedness for nuclear, biological, and chemical threats.  She currently serves as Senior Scientist for the Global Health and Security Initiative of the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons.  A graduate of Radcliffe College, she earned her M.D. from Harvard Medical School, and completed her training at the New York Hospital/Cornell University Medical Center.

From 1997 to 2001, Hamburg held the position of Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services (HHS), serving as principal policy advisor to Secretary of Health and Human Services Donna Shalala.  From 1991 to 1997, she served as New York City Health Commissioner, a position in which she designed and implemented an internationally recognized tuberculosis control program that produced dramatic declines in tuberculosis cases, and created the first public health bio-terrorism preparedness program in the nation.  Between 1986 and 1990, she held a variety of positions within HHS, including Special Assistant to the Director, Office of Disease Prevention and Health Promotion; and Special Assistant to the Director, and later Assistant Director, of the National Institute of Allergy & Infectious Diseases at the National Institutes of Health.

A member of the Harvard College Board of Overseers and the Boards of Trustees of Rockefeller University and the Rockefeller Foundation, Hamburg is also a distinguished senior fellow with the Center for Strategic and International Studies, and a fellow of the American Association of the Advancement of Science.  She holds membership in the New York Academy of Medicine, and the Council on Foreign Relations and serves on the board of Henry Schein Company.  She has served on the boards of other organizations, including the New York City Health and Hospitals Corporation, the Nathan Cummings Foundation, the Primary Care Development Corporation, and the Board of Scientific Counselors for the National Center for Infectious Diseases of the Centers for Disease Control and Prevention.

James M. Phillips, Vice Chairman, Luminetx

James “Jim” Phillips’s career has been marked by success at starting and guiding companies through successful initial public offerings and pioneering new technologies into major industry-leading positions – including the PDA, digital cell phone, fixed cellular and internet multimedia.  A classic entrepreneur, Phillips’ began his career with Telecommunications System of America, which was sold to Northern Telecom (Nortel), where Phillips eventually became vice president.  He held subsequent executive positions at SkyTel, which became the nation’s largest messaging company; Telular Corporation, the world’s largest fixed wireless cellular company; and Motorola, where he participated in launching digital cellular and multimedia, bringing cable modem to the market.

Phillips then became Chairman and CEO of IPIX, which produced digital photographs with 360° navigable images that are today widely used on major Web sites.  After taking the company public, he was asked to become involved with the effort to build the FedEx Institute of Technology (FIT), a partnership between Federal Express Corp. and The University of Memphis.  Phillips resigned from IPIX, moved to Memphis and raised $100 million to make FIT a reality.  Information Week has called FIT the technology industry’s “newest center for innovation” and WIRED has compared it to the famous Media Lab at MIT.

After successfully launching FIT, Phillips served as CEO in residence at Morgan Keegan, a Memphis-based investment firm, before raising the capital to launch Luminetx Corporation.  Luminetx produces the VeinViewer, which was named in 2004 by Time as “one of the coolest medical inventions of the year.”  Phillips is Vice Chairman of Luminetx, having previously served as the company’s CEO, president and chairman.  A holder of patents in cell phone, PDA and data modem design, he also serves on a number of boards including the American Museum of Science and Energy, Visio Technologies Corporation, EmergeMemphis, Memphis Biotech Foundation, University of Memphis Fogelman School of Business and Economics, and the Memphis Area Chamber of Commerce.

Source :http://www.nationalhealthmuseum.org/news/articles/trustees_update.html

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.