Fuad El-Hibri Blog

June 15, 2009

Fuad El-Hibri and Emergent gets boost from FDA

Fuad El-Hibri and Emergent gets boost from FDA

Emergent BioSolutions hit a jackpot of sorts when the Food and Drug Administration approved extending the shelf life of its anthrax vaccine from three to four years.

The milestone approval means that the vaccines that the Rockville biotech has already sold to the Department of Health and Human Services‘ Strategic National Stockpile are worth $30 million more than the original price. In a statement, Emergent said it plans to record that extra income in the current quarter.

Furthermore, the extended shelf life means that the value of the company’s contract for 14.5 million additional doses has increased to $405 million.

“We are pleased that the FDA has approved the 4-year expiry dating of BioThrax as this extends the ability of the U.S. government to store our product in the nation‘s Strategic National Stockpile,” said Fuad El-Hibri, chairman and CEO.

“This is a critically important product feature that we believe will increase the attractiveness of BioThrax to the U.S. government as it increases BioThrax’s life cycle value. We are continuing our efforts to further enhance the attributes of BioThrax, including research toward a further reduction in the vaccination schedule and an expanded label indication for post-exposure prophylaxis. We believe these enhancements, if approved, will advance the U.S. government’s preparedness efforts in response to anthrax as a potential weapon of bioterrorism.”

Emergent has supplied more than 33 million doses of BioThrax, the only FDA-approved anthrax vaccine, to the federal government, with more deliveries scheduled through the third quarter of 2011.

Also this week, Emergent sued privately held Protein Sciences Corp. of Meriden, Conn., which it planned to acquire last year, according to a filing with the Securities and Exchange Commission. In connection with the planned acquisition, Emergent made a $10 million loan to Protein Sciences, which used its assets as collateral. A May 31 deadline for repayment passed, prompting the suit, Emergent said.

Emergent also plans to proceed with its pending lawsuits against Protein Sciences and its management, including claims for breach of contract, fraud and unfair business practices.

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Fuad El-Hibri Recombinant Anthrax Vaccine Contract

Fuad El-Hibri Recombinant Anthrax Vaccine Contract

Emergent BioSolutions Inc. (NYSE:EBS) announced that late on April 15th, HHS requested that each bidder in the competitive range for the rPA contract submit its product development plans to FDA for review in advance of an award. Emergent had already requested and is presently scheduling a meeting with the FDA as part of its pre-award activity. The Company intends to incorporate any FDA comments into its rPA development plan. Emergent will continue to move its rPA program forward to position the company to execute on the anticipated contract, once awarded.

“We strongly support this step by HHS, which potentially reduces development risk for our rPA vaccine candidate. We remain confident that we are well-positioned and competitive to receive any award granted by HHS for the development and procurement of the rPA vaccine. We look forward to continuing our long-standing relationship with the US Government as the proven and preeminent supplier of medical countermeasures to protect our nation,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

As with any government solicitation of this size and scope, there are no assurances that HHS will not impose additional requirements, which may further extend contract negotiations.

This action has no impact on the company’s existing contracts with HHS to supply BioThrax®, the only FDA licensed anthrax vaccine, for the Strategic National Stockpile (SNS). This year Emergent is completing the delivery of 18.75 million doses of BioThrax for inclusion in the SNS. Also this year, following the completion of that delivery, Emergent will begin to supply HHS with an additional 14.5 million doses of BioThrax under a follow-on contract. The total value of these two procurement contracts with HHS for BioThrax exceeds $800 million.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and 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 licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at http://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, 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 clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 annual report on Form 10-K for the year ended December 31, 2008 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.

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

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.
Investors:
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
Media:
Tracey Schmitt, 301-795-1800
Director, Corporate Communications
SchmittT@ebsi.com

Copyright Business Wire 2008

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Fuad El-Hibri is an American University Board Trustee

Fuad El-Hibri is an American University Board Trustee

Gary M. Abramson*, Chairman of the Board, Partner, The Tower Companies, North Bethesda, MD

Thomas A. Gottschalk, Vice Chair of the Board, Executive Vice President, Law and Public Policy, and General Counsel, General Motors Corp., Detroit, MI

Stephanie M. Bennett-Smith, President Emerita, Centenary College, Hackettstown, NJ

David M. Carmen, President and CEO, Carmen Group Inc., Washington, DC

Edward R. Carr*, President (retired), CarrHomes, Inc., Falls Church, VA

Jack C. Cassell*, President and CEO, Visual Aids Electronics & Conference Systems, Inc., Germantown, MD

Gary D. Cohn*, President and Co-Chief Operating Officer, Goldman Sachs & Co., New York, NY

Pamela M. Deese*, Partner, Arent Fox PLLC, Washington, DC

Jerome King Del Pino, General Secretary, General Board of Higher Education and Ministry, United Methodist Church, Nashville, TN

David R. Drobis*, Chairman Emeritus, Ketchum Worldwide, Naples, FL

Fuad El-Hibri, President, East West Resources Corp., Rockville, MD

Gisela B. Huberman*, President, GBH Radio, Inc., Fisher Island, FL

Hani M.S. Farsi*, Managing Director and Chairman, Reservoir Management Services Ltd., London, England

C. Nicholas Keating, Jr.*, President and CEO, Network Equipment Technologies, Fremont, CA

Cornelius M. Kerwin*, Interim President, American University, Washington, DC

Margery Kraus*, President and CEO, APCO Worldwide, Washington, DC

Charles H. Lydecker*, Executive Vice President, Brown & Brown, Inc., Daytona Beach, FL

A. Robyn Mathias*, Principal (retired), Rolling Terrace Elementary School, Bethesda, MD

Regina L. Muehlhauser*, President (retired), Bank of America San Francisco, Pleasanton, CA

Matthew S. Pittinsky*, Chairman and Co-Founder, Blackboard, Inc., Washington, DC

Arthur J. Rothkopf, Senior Vice President and Counselor to the President, U.S. Chamber of Commerce, Washington, DC

Mark L. Schneider, Senior Vice President, International Crisis Group, Washington, DC

John R. Schol, Bishop, Baltimore-Washington Conference of The United Methodist Church, Washington, DC

Neal A. Sharma*, CEO, Digital Evolution Group, Overland Park, KS

Jeffrey A. Sine*, Vice Chairman and Global Head of Telecommunication and Technology, UBS Securities LLC, New York, NY

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Fuad El-Hibri at Washington DC Gala

Fuad El-Hibri at Washington DC Gala

The Gala brought together some 430 Arab and Lebanese-Americans, as well as former and current U.S. Administration officials, Arab ambassadors and diplomats, and Lebanese-American leaders from around the USA, all united by a common will of promoting peace and stability in Lebanon.

H.E. Nayla Moawad, Founder and Honorary President of the Foundation, former First Lady of Lebanon, and current Minister of Social Affairs hosted this special occasion. Some of the honored guests included Minister Sami Haddad and Minister Jihad Azour. Former World Bank President Paul Wolfowitz was also in attendance.

The Keynote address was given by H.E. Ambassador Antoine Chedid. Distinguished Community Service and Achievement Awards were given to two very deserving recipients: Mr. Fuad El-Hibri, Chairman and CEO of Emergent BioSolutions, and the Partnership for Lebanon, established in September 2006 by US business leaders to assist the reconstruction efforts and to help the people of Lebanon find the path to long-term stability and economic growth. The Partnership’s leaders include the CEOs of Microsoft, Cisco Systems, Intel Corporation, Ghafari Inc. and Occidental Petroleum.

The evening also featured a fashion show by the renowned Lebanese designer Jean Fares, who is known for combining beauty and fashion. His designer collection is designed with original concepts and an impeccable finish.

This year’s event will support the many educational programs that RMF is undertaking in Lebanon, thereby giving its youth a better educational environment and a more promising future.


H.E. Mrs Nayla Moawad


Minister Jihad Azour, Mr. Abdo Sabban
and Ambassador Vincent Battle


Mrs. A. Chedid, Ambassador A. Chedid, Mrs. Moawad, Mr. Paul Wolfowitz and Mr. Michel Moawad


Mr. Michel Moawad, MP Jawad Boulos


Mrs. Moawad presenting award to Mr. Fuad El-Hibri


From the fashion show


Mrs Moawad presenting award to Mr. Jean Fares

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Fuad El-Hibri and Emergent BioSolutions Inc. Profits and Losses

Fuad El-Hibri and Emergent BioSolutions Inc. Profits and Losses

Delayed orders of its anthrax product drastically cut into Emergent BioSolutions Inc.’s fourth-quarter revenue and profits.

The Rockville biotech earned nearly $35.8 million in revenue in the fourth quarter last year, a 60 percent drop from the $89.6 million it pulled in during the same period of 2007. That also resulted in a nearly 95 percent plunge in fourth-quarter profits, from $27.7 million to nearly $1.5 million.

The company said it had expected to ship three additional lots of its BioThrax anthrax vaccine to the U.S. Department of Health and Human Services during the fourth quarter — representing $12 million worth of product sales — but that delivery was delayed.

“Such an event is further evidence that our revenues fluctuate quarter to quarter based on the timing of deliveries of BioThrax to HHS,” said Don Elsey, chief financial officer, in a statement.

Despite that drop, Emergent’s revenue for the full year in 2008 dipped only 2 percent, from $182.9 million to $178.5 million, and profit fell 10 percent, from $22.9 million to $20.7 million. Nearly all of the company’s product sales came from BioThrax, and Emergent said it saw a 16 percent drop in BioThrax doses delivered to HHS. That was offset, though, by an 18 percent rise in Emergent’s BioThrax dose price.

The company earns most of its money from HHS contracts. While Emergent still has two contracts outstanding, worth a total $853 million, to deliver more than 33 million doses to HHS, the larger of those two contracts, worth $448 million, will be completed in the third quarter of this year.

Emergent is awaiting an HHS decision on its bid last year to sell 25 million doses of a separate anthrax vaccine to the agency — a negotiation process that has been delayed by a protest from one of the other bidders on the HHS request for proposals, Emergent officials said.

“When you have two parties you can maybe exercise control over one party, which is ourselves. Our relationship with HHS continues to be strong, and we’re excited about this opportunity,” said Fuad El-Hibri, chief executive officer, in a conference call with analysts. “These are half-billion-dollar types of contracts. They just take time to negotiate.”

Emergent thinks its revenue this year will grow by 25 to 35 percent and lie between $225 million and $240 million. It also expects profits to exceed $20 million this year.

Emergent had plans to expand its manufacturing space into Frederick, Md., but those plans have been put on hold as it concentrates its work at a current plant in Lansing, Mich. Emergent officials have been wary of giving any timelines for further manufacturing expansions but did say nothing would occur before the end of next year.

“We would be using existing manufacturing process, existing scale, existing equipment,” El-Hibri said. “We have plenty of space.”

By the end of last year, the company had $91.5 million in cash and equivalents.

Emergent’s share price (NYSE: EBS) dropped $1.08, or a little more than 6 percent, in trading after closing bell Thursday, when the company released its earnings.

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Fuad El-Hibri and Emergent BioSystems on the Alacra Store

Fuad El-Hibri and Emergent BioSystems on the Alacra Store

The Group’s principal activities are developing, manufacturing and commercialization of immunobiotics. It operates through two segments: Biodefense: Focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. BioThrax(R), its marketed product is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. The Commercial segment focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. The Commercial product portfolio includes a typhoid vaccine candidate and a hepatitis B therapeutic vaccine candidate, both of which are in Phase II clinical development, a group B streptococcus vaccine candidate in Phase I clinical development and two vaccine candidates in preclinical development.

Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Finalist in Greater Washington Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Finalist in Greater Washington

Emergent BioSolutions Inc.

2273 Research Boulevard
Suite 400
Rockville, MD 20850
United States
Tel: 1/301 795-1899
URL: http://www.emergentbiosolutions.com/
Primary Symbol & Exchange:
EBS – Common Stock – New York Stock Exchange
Industry:
Biotechnology
+ SIC Industry Code:
+ NAICS Industry Code:
Mergers & Acquisitions:
Emergent BioSolutions Inc. Mergers and Acquisitions
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About Fuad and Ibrahim El-Hibri

3 quick facts about Ibrahim El-Hibri:
El-Hibri is a former director of the British maker of a different anthrax vaccine

Source: www.michigandaily.com… [www.michigandaily.com]

At the time of the BioPort bid, El-Hibri was a German citizen of Lebanese heritage…

Source: forums.perseusbooksgroup.com… [forums.perseusbooksgroup.com]

El-Hibri is a U.S.-born citizen, her husband Fuad was educated at Yale and has applied for U.S…

Source: members.tripod.com [members.tripod.com]

Click here for a comprehensive search on Ibrahim El-Hibri…
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Fuad El-Hibri Quarter 4 Profits

Fuad El-Hibri Quarter 4 Profits

Delayed orders of its anthrax product drastically cut into Emergent BioSolutions Inc.’s fourth-quarter revenue and profits.

The Rockville biotech earned nearly $35.8 million in revenue in the fourth quarter last year, a 60 percent drop from the $89.6 million it pulled in during the same period of 2007. That also resulted in a nearly 95 percent plunge in fourth-quarter profits, from $27.7 million to nearly $1.5 million.

The company said it had expected to ship three additional lots of its BioThrax anthrax vaccine to the U.S. Department of Health and Human Services during the fourth quarter — representing $12 million worth of product sales — but that delivery was delayed.

“Such an event is further evidence that our revenues fluctuate quarter to quarter based on the timing of deliveries of BioThrax to HHS,” said Don Elsey, chief financial officer, in a statement.

Despite that drop, Emergent’s revenue for the full year in 2008 dipped only 2 percent, from $182.9 million to $178.5 million, and profit fell 10 percent, from $22.9 million to $20.7 million. Nearly all of the company’s product sales came from BioThrax, and Emergent said it saw a 16 percent drop in BioThrax doses delivered to HHS. That was offset, though, by an 18 percent rise in Emergent’s BioThrax dose price.

The company earns most of its money from HHS contracts. While Emergent still has two contracts outstanding, worth a total $853 million, to deliver more than 33 million doses to HHS, the larger of those two contracts, worth $448 million, will be completed in the third quarter of this year.

Emergent is awaiting an HHS decision on its bid last year to sell 25 million doses of a separate anthrax vaccine to the agency — a negotiation process that has been delayed by a protest from one of the other bidders on the HHS request for proposals, Emergent officials said.

“When you have two parties you can maybe exercise control over one party, which is ourselves. Our relationship with HHS continues to be strong, and we’re excited about this opportunity,” said Fuad El-Hibri, chief executive officer, in a conference call with analysts. “These are half-billion-dollar types of contracts. They just take time to negotiate.”

Emergent thinks its revenue this year will grow by 25 to 35 percent and lie between $225 million and $240 million. It also expects profits to exceed $20 million this year.

Emergent had plans to expand its manufacturing space into Frederick, Md., but those plans have been put on hold as it concentrates its work at a current plant in Lansing, Mich. Emergent officials have been wary of giving any timelines for further manufacturing expansions but did say nothing would occur before the end of next year.

“We would be using existing manufacturing process, existing scale, existing equipment,” El-Hibri said. “We have plenty of space.”

By the end of last year, the company had $91.5 million in cash and equivalents.

Emergent’s share price (NYSE: EBS) dropped $1.08, or a little more than 6 percent, in trading after closing bell Thursday, when the company released its earnings.

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Fuad El-Hibri and EBS Initial Public Offering

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.

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