Anthrax Vaccine by Fuad El-Hibri

Fuad El-Hibri next generation anthrax vaccine

FOR IMMEDIATE RELEASE CONTACT: Caree Vander Linden
May 12, 2008 (301) 619-2285
Caree.Vander-Linden@amedd.army.mil

USAMRIID’s Next Generation Anthrax Vaccine Acquired for Advanced Development

An anthrax vaccine discovered and initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has been acquired by a Maryland-based firm for advanced development that could lead to eventual licensure of the product by the Food and Drug Administration.

According to company officials, Emergent BioSolutions Inc. has acquired the next generation anthrax vaccine, as well as the technology on which it is based. This vaccine candidate was patented by USAMRIID and previously licensed to a company called VaxGen, which had pursued advanced development since 2002 under a contract from the U.S. Department of Health and Human Services.

The vaccine uses recombinant protective antigen, or rPA, a protein secreted by the anthrax bacterium, Bacillus anthracis. This protein induces the body’s immune system to produce antibodies against the bacteria’s toxins. In several nonhuman primate studies conducted at USAMRIID, rPA has demonstrated the ability to induce a high level of protection against inhalational anthrax—the type most likely to occur following a bioterrorist event.

“We believe this acquisition will facilitate the continued development of this promising anthrax vaccine candidate,” said Colonel George W. Korch, Jr., commander of USAMRIID. “We are excited about the future prospects for rPA as an effective medical countermeasure for the nation’s biodefense.”

Anthrax is caused by spores and most commonly occurs in wild and domestic mammals, although it has the potential to be used as a biological threat agent. Symptoms vary depending on the route of exposure; however, sore throat, mild fever, and muscle aches usually begin within 7 days of exposure. Severe breathing difficulty, shock, and meningitis can follow, and as the bacteria multiply in the lymph nodes, toxemia progresses and the potential for widespread tissue destruction and organ failure increases. Up to 90 percent of untreated cases of inhalational anthrax result in death. Obtaining an alternative for the currently licensed anthrax vaccine would provide the Department of Defense—and the nation—with additional options in protecting against this threat.

USAMRIID’s proprietary technology also has a number of potential manufacturing advantages, including the ability to express full-length soluble anthrax PA in a non-toxic, non

spore-forming strain of the anthrax bacterium. When full-length rPA is expressed in anthrax bacteria, it is secreted into the culture fluid, from which it can be isolated in a highly purified form. This material also has the potential to provide broader protection against anthrax.

“By acquiring this particular vaccine candidate, Emergent will be able to leverage over a decade of development work conducted at USAMRIID and 5 years of experience and advanced development work conducted by VaxGen, in order to continue the development of this vaccine through to licensure,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc.

USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Department of Defense Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute conducts basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. While USAMRIID’s primary mission is focused on the military, its research often has applications that benefit society as a whole. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil

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Fuad El-Hibri hired W. James Jackson, Ph.D. at Emergent BioSolutions Inc.

ROCKVILLE, Md.–(Business Wire)– Emergent BioSolutions Inc. (NYSE: EBS) announced today that W. James Jackson, Ph.D., has been appointed chief scientific officer, effective immediately. Dr. Jackson will report directly to Fuad El-Hibri, chairman and chief executive officer.

As CSO, Dr. Jackson will lead the company’s scientific evaluation of new products and technology platforms and will be responsible for building and managing Emergent’s scientific advisory board. Additionally, Dr. Jackson will support the CEO in external communications by providing scientific expertise and perspective about the company’s technologies, platforms, and product candidates to government agencies and officials, investors, analysts and at scientific meetings.

“I am honored to be named chief scientific officer of Emergent BioSolutions. Because we are such a pioneering and growth-oriented company, I look forward to playing a leading role in the company’s new product acquisition efforts, and to applying my experience to help extend the company’s product portfolio in pursuit of our strategic goals,” said Dr. Jackson.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions said, “After an extensive search including interviews with a variety of internal and external candidates, I am very pleased to appoint Dr. Jackson to this important post. Jim’s breadth and depth of experience and his intimate knowledge of our pipeline make him particularly suited to serve as Emergent’s chief scientific officer. I look forward to working closely with him in this new capacity and am confident his expertise will provide leadership to our development initiatives and add value to our company as a whole.”

Dr. Jackson joined Emergent BioSolutions in 2003, as a result of Emergent’s acquisition of Antex Biologics Inc., where Dr. Jackson had been vice president of research and development. Since 2003, Dr. Jackson has served in several management capacities within the company including vice president, commercial product development and most recently as vice president, technical support. Dr. Jackson brings over 20 years of biopharmaceutical research and development experience to the company, including leading research efforts related to antigen identification and characterization, pre-clinical evaluation, and initial development of bacterial vaccines in the areas of respiratory, enteric, and sexually transmitted diseases. Among his accomplishments, Dr. Jackson has been issued 17 U.S. and foreign patents, obtained a number of state and federal research grants and has published frequently in various scientific journals. Dr. Jackson holds a Ph.D. in microbiology from the University of Georgia.

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. Our products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Our 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. More information on the company is available at www.emergentbiosolutions.com.

Emergent BioSolutions Inc.
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