Fuad El-Hibri Wire

Fuad El-Hibri, MBA
Chief Executive Officer and Chairman of the Board of Directors
Emergent Biosolutions, Inc.
Yale School of Management

Mr. El-Hibri has served as chairman of East West Resources Corporation, a venture capital and financial consulting firm, since June 1990. He served as president of East West Resources from September 1990 to January 2004. Mr. El-Hibri 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 the NIH, Oxford University and Cambridge University. He also serves as chairman and treasurer of El-Hibri Charitable Foundation. Mr. El-Hibri received a master’s degree in public and private management from Yale University and a B.A. in economics from Stanford University.

Fuad El-Hibri and EBS Initial Public Offering

A Gaithersburg drug company that makes most of its money selling the only federally approved vaccine against anthrax is in the final stages of preparing an initial public offering to raise up to $92 million.

Late last month, Emergent Biosolutions Inc. set the range of its offering at $14 to $16 a share. The company said it intends to use the money on its manufacturing facilities in Frederick and Michigan and to fund development of several products, according to documents filed with the Securities and Exchange Commission.

The company is tightly controlled by Fuad El-Hibri, its chairman and chief executive. El-Hibri, who lives in Potomac, has an extensive background in the telecommunications industry. He and his father have also had significant involvement with a British provider of anthrax vaccines. El-Hibri, who became a U.S. citizen in 1999, was born in Germany and grew up around Europe and the Middle East before attending Stanford and Yale universities.

El-Hibri controls 99.5 percent of the Emergent’s outstanding stock. After going public, he will control 81.4 percent. In SEC documents, the company said El-Hibri “will continue to have substantial control over us after this offering, including through his ability to control the election of the members of our board of directors, and could delay or prevent a change of control.”

Biotech analysts said Emergent could have a tough time with its initial public offering. Just two biotech companies — Osiris Therapeutics, a Baltimore biotechnology firm working on stem-cell therapies, is one — went public in the third quarter, and the market for IPOs in general has been spotty.

According to Thomson Financial, more companies have withdrawn IPOs this year than in any of the previous five years, indicating investors are skeptical of new company stock offerings despite the generally strong market for stocks. And venture capital-backed IPOs, traditionally the most prolific source of new company issues, fell significantly in the third quarter.

Companies that have managed to go public are in a broad range of industries, and those that have had the most success are in tried-and-true money-making or technologically hot industries. For example, locally, government contracting giant SAIC Inc. is up 33 percent since its Oct. 12 IPO. And Osiris Therapeutics is up 89 percent since its August IPO.

Emergent Biosolutions’ effort to finish its IPO comes as federal health officials deal with a troubled $877.5 million contract for another anthrax vaccine, made by VaxGen Inc. VaxGen is supposed to provide 75 million doses for the national stockpile, but the Food and Drug Administration recently halted human testing of the California company’s vaccine because of concerns about its potency, throwing the entire contract into doubt.

VaxGen’s contract was awarded under the Project Bioshield initiative, which seeks to develop modern vaccines and drugs for chemical, biological, radiological or nuclear attacks. VaxGen’s proposed anthrax vaccine, if successful, would require fewer doses over a shorter period of time to produce immunity than the older version made by Emergent.

Emergent has been urging Congress and federal health officials to buy more of its anthrax vaccine, called BioThrax, for the stockpile. The efforts are being aided by Louis W. Sullivan, who was health and human services secretary from 1989 to 1993, and Jerome M. Hauer, a former senior HHS official who oversaw public health emergency preparedness. Both men are on Emergent’s board.

So far, the government has purchased 10 million doses.

In its SEC filings, Emergent said the government’s efforts to stockpile a newer version “would limit, possibly significantly, the market for BioThrax.” The company said it is in the early stages of developing a next-generation anthrax vaccine and products for other diseases and bioterrorism agents.

Emergent officials could not comment because the company is in a quiet period before its offering.

While the $5.6 billion Project Bioshield program is potentially the most lucrative outlet for BioThrax, Emergent also sells the vaccine to the Defense Department. Since 1998, the Defense Department has vaccinated 1.5 million people with more than 5.7 million doses, according to SEC documents. It is providing 1.5 million doses to the military through September 2007.

BioThrax has been controversial in the military. Some soldiers have complained of significant side effects and have refused to use the vaccine, leading to a court battle that temporarily stopped mandatory vaccinations. The government recently resumed mandatory vaccinations with BioThrax after the FDA said the vaccine was safe and effective.

John T. McCamant, editor of the Medical Technology Stock Letter, said Emergent’s IPO could be particularly difficult because the only customer for bioterrorism products is the government.

“That’s a tall trick because the money will come in lumps at best,” he said.

Staff writer Terence O’Hara contributed to this report.

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.

Fuad El-Hibri Next Generation Anthrax Vaccine

Jun 15
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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

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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Posted in Anthrax Vaccine, El-Hibri Fuad, Emergent BioDefense, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: Anthrax, Emergent BioSolutions, Fort Detrick, Infectious disease, United States Army Medical Research Institute of Infectious Diseases, United States Department of Health and Human Services, US Army Medical Research Institute of Infectious Diseases, USAMRIID, VaxGen

Emergent BioSolutions Inc. announced that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.

Fuad El-Hibri’s Emergent BioSolutions gets market authorization in India for BioThrax

According to a release, Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the U.S. Food and Drug Administration (FDA).

The company noted that the BioThrax market authorization for India follows the publication in 2008 of the National Disaster Management Guidelines by the Indian National Disaster Management Authority (NDMA), which is the government body that oversees disaster management. In that document, the  government of India provided guidance with respect to the management of biological disasters and said that there is a need to have a supply of readily available anthrax vaccines to be administered rapidly in the event of an outbreak. The report goes on to state that all first responders will be vaccinated in an impending disaster situation.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said, “The Government of India has been explicit in expressing its commitment to protect its population from the continuing threat of bioterrorism. We are certainly pleased that BioThrax will be a valuable countermeasure available to the Government of India to achieve that goal. Today marks a pivotal milestone in Emergent’s efforts to expand globally and further our mission of protecting life.”

About BioThrax (Anthrax Vaccine Adsorbed): BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis and contains no dead or live bacteria. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, nearly 8.4  million doses have been administered to more than 2.1 million military personnel. BioThrax cannot cause anthrax infection. Please visit emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf for full prescribing information.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.

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For full details on Emergent BioSolutions Inc (EBS) click here. Emergent BioSolutions Inc (EBS) has Short Term PowerRatings of 1. Details on Emergent BioSolutions Inc (EBS) Short Term PowerRatings is available at This Link.

Posted in BioThrax, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
Tags: Bacillus anthracis, BioThrax, Emergent BioSolutions, Government of India, India, United States, US Food and Drug Administration, Vaccine