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Fuad El-Hibri EBS IPO and BioThrax

June 21st, 2009 admin No comments

“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.”

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.

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.


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.


Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri, Initial Public Offering
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Fuad El-Hibri Profits and Losses

June 21st, 2009 admin No comments

“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.”

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.

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 hires W. James Jackson, Ph.D.

June 21st, 2009 admin No comments
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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.”

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.

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


Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri

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Anthrax Vaccine by Fuad El-Hibri

June 21st, 2009 admin No comments

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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Fuad El-Hibri Appoints Allen Shofe

June 21st, 2009 admin No comments

Emergent BioSolutions Inc. today announced the appointment of Allen Shofe to the position of Vice President of Government Affairs. Fuad El-Hibri appoints Allen Shofe Vice President of Government Affairs

Emergent BioSolutions Appoints Allen Shofe Vice President of Government Affairs

GAITHERSBURG, Md., Sept. 15 /PRNewswire/ — Emergent BioSolutions Inc. today announced the appointment of Allen Shofe to the position of Vice President of Government Affairs.  In this position, Mr. Shofe will be responsible for designing, implementing and overseeing all aspects of the company’s domestic and international government affairs initiatives.

“Allen is a versatile and highly astute government relations and public affairs executive,” said Fuad El-Hibri, CEO of Emergent BioSolutions.  “His government affairs expertise and extensive network of professional contacts throughout the United States and Europe will prove invaluable as we continue our efforts to become a global leader in our field.”

Mr. Shofe has more than 15 years experience in government relations and government affairs at the Federal and state levels, as well as in the international arena.  Mr. Shofe previously held the position of Director of Federal Government Relations at Eli Lilly and Company, where he managed a series of government initiatives, including those that focused on intellectual property, patent law and tort reform.  Mr. Shofe received his BA in International Relations/Diplomacy at the University of Minnesota and an LL.M, Master of Laws from the University of Leicester in the United Kingdom. “I look forward to the opportunity to help advance Emergent BioSolutions into a world class biopharmaceutical company,” said Mr. Shofe.  “This company has such a promising future, and to be a part of its growth and success is something I am extremely proud of.”

About Emergent BioSolutions
Emergent BioSolutions Inc., formed in 2004, is dedicated to the research, development and manufacture of novel products which harness the immune system to treat and prevent disease.  These include vaccines and related products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction.  The company currently employs more than 450 people with facilities in Gaithersburg and Frederick, Maryland, Lansing, Michigan, Berkshire, U.K. and Munich Germany.  More information about Emergent BioSolutions and its subsidiaries can be found at http://www.ebsi.com


Posted in Allen Shofe, El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri
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Tuberculosis Vaccine by Fuad El-Hibri

June 21st, 2009 admin No comments
The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort:

Tuberculosis Vaccine by Fuad El-Hibri

Fuad El-Hibri’s EBS is Developing TB Vaccine

Jun 15
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Fuad El-Hibri’s EBS is Developing TB Vaccine

“The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort,” said Jerald C. Sadoff, president and CEO of Aeras, in a statement.

“This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world’s deadliest diseases,” said Fuad El-Hibri, chairman and CEO of Rockville biotech Emergent BioSolutions, which is teaming with the University of Oxford on the TB project.


Fuad El-Hibri Key Executive at Emergent

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

June 21st, 2009 admin No comments

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.

((Comments on this story may be sent to health@closeupmedia.com))

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.

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Fuad El-Hibri’s Emergent BioSolutions’ Typhoid Vaccine

June 21st, 2009 admin No comments

We are very pleased to have met the objectives of this Phase II study of our typhoid vaccine candidate:

Fuad El-Hibri’s Emergent BioSolutionsTyphoid Vaccine Candidate Achieves Endpoints in Phase II Clinical Study

“We are very pleased to have met the objectives of this Phase II study of our typhoid vaccine candidate. This data is encouraging and indicates great promise for what would be the first single-dose, drinkable typhoid vaccine. We are particularly grateful to the Wellcome Trust for their partnership and generous support of this important project,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “Typhoid is endemic in many developing countries, putting countless international travelers and families who visit these nations at risk. With typhoid claiming 200,000 lives each year, continued progress in the development of this vaccine is an important milestone in our company’s efforts to protect life. Emergent BioSolutions remains committed to addressing significant underserved health needs,” he continued.

About the Typhoid Vaccine Candidate

The company’s typhoid vaccine candidate is a live, attenuated strain of the Salmonella typhi bacterium designed to eliminate virulence by deletion of two specific genes. The vaccine is intended to be administered in a single, drinkable dose prior to travel to countries where typhoid is endemic. If approved, this method of administration could provide a competitive advantage compared to currently approved typhoid vaccines.


Fuad El-Hibri EBS Typhoid Vaccine

Jun 15
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Fuad El-Hibri EBS Typhoid Vaccine

Emergent BioSolutions is on the path to finding gold with its typhoid vaccine following positive results in a Phase II trial.

The Maryland-based biopharmaceutical company is developing a single-dose oral drinkable typhoid vaccine aimed to take on Crucell’s three to four dose oral formulation and Sanofi’s injectable formulation. The global travellers market was worth $130m (€92m) in 2003, and is expected to increase to $200m by 2014.

According to the company, the typhoid vaccine candidate achieved the study endpoints for safety and immunogenicity with an overall immune response rate of greater than 50 per cent, with 95 per cent confidence.

“We are very pleased to have met the objective of this Phase II study of our typhoid vaccine candidate. This data is encouraging and indicates great promise for what would be the first single-dose, drinkable typhoid vaccine,” Emergent BioSolutions chairman and chief executive Fuad El-Hibri said.

Typhoid is endemic in many developing countries, putting countless international travellers and families who visit these nations at risk. With typhoid claiming 200,000 lives each year, continued progress in the development of this vaccine is an important milestone in our company’s efforts to protect life.”

The company’s typhoid vaccine candidate is a live, attenuated strain of the Salmonella typhi bacterium designed to eliminate virulence by deletion of two specific genes.


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