Wednesday, December 16, 2009

Fuad el-Hibri, king of anthrax, wins an award from Ernst & Young

Marie-José Daoud

Awarded the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region last June, Fuad El-Hibri is the CEO of Emergent Biosolutions, an American company that supplies the anthrax vaccine to the American government. He is in line for the national E&Y 2009 prize, which will be awarded on November 14 in California.

He is a tall, imposing and smiling man. He has the assurance of those who are proud of their career and the modesty of those who attribute their success to the staff around them. He has just won the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region. This prize rewards over 15 years in the biopharmaceutical industry, ten of which have been dedicated to Emergent Biosolutions, the company that supplies the only anthrax vaccine approved by the American government’s powerful Food and Drug Administration (FDA). Fuad El-Hibri landed in biopharmaceuticals somewhat by chance and somewhat by interest. He defines himself as “an entrepreneur in spirit” and, before dedicating himself to biopharmaceuticals, he had already created and sold various telecommunications companies in Russia, Venezuela and El Salvador. In the early 90s, this German native, born to a Lebanese father and a German mother, and who had spent time in the banking industry (Citibank) and consultant (BoozAllen & Hamilton), joins Porton Product, a biotechnology company located in the United Kingdom. There he plays a predominant role in marketing and sales of biodefense vaccines to foreign governments. Hibri is, in particular, a key man behind the purchase by Saudi Arabia of anthrax vaccines during the first Gulf war. This is where he maintains he gained his insight into the magnitude of the need for medical solutions to combat bioterrorism. In 1994, he organized the buy-back of Porton Products by its managers, before reselling his shares in 1996 (the price is not known).

In 1998, an opportunity opened up for him to buy BioThrax in competitive bidding, the only anti-anthrax vaccine approved by the Food and Drug Administration, until then owned by the State of Michigan. So he creates BioPort, obtains American nationality . in 1999, wins the bidding (approximately 24 million dollars) and finds himself at the head of a company with 170 employees, and develops a product: BioThrax.

Hibri has in fact the advantage of a monopoly situation since he is the only supplier of the American government who buys millions of doses of BioThrax per year from him to vaccinate its servicemen and to maintain a stock in case of bioterrorist attack. A situation which fuels all the controversies, as proved by the frenzied comments posted on the Internet.

Once BioPort is consolidated, and to diversify his portfolio, Hibri buys several biotechnology companies. In 2003, BioPort buys Antex, an American company working on the development of a vaccine against chlamydia. In 2005, the company, which in the meantime has become Emergent Biosolutions, acquired Microscience, an English company which had invested in research on hepatitis B and typhoid. In 2006, it purchased VIVACS, a German company specialized in research on the influenza vaccine. In 2008, it does a joint venture with Oxford University (among others) to develop a vaccine against tuberculosis.

Today, Emergent is at the head of a developing portfolio of vaccines and treatments against seven diseases which could bring in “hundreds of millions of dollars per year” when the products are on the market, according to Hibri. Four of these should be on the market within four to seven years. Most of these products have the specific feature of only requiring two technologies that the company has: a technology for vaccines given orally and another for vaccines administered by injection. “Which leads to major synergies enabling substantial cost savings to be made,” explains Hibri. But Emergent is in direct competition with large pharmaceutical laboratories such as Sanofi, Novartis and Roche on the development of these treatments and vaccines, of more commercial use than BioThrax. Furthermore, even with anthrax, Emergent will probably have to face competition from other biotechnology laboratories, like PharmAthene and Cangene, who are currently in the development phase of vaccines and treatment against the bacterium. In the meantime, to meet increasing demand from the American government, and that of other foreign governments who fill out its client portfolio, Emergent has recently invested in its BioThrax production capacity: it has gone from a capacity of three million doses per year to eight million and is currently validating a new factory in Michigan which can produce up to 40 million doses per year.

Today, eleven years after acquiring BioThrax, the latter, still provides the bulk of the company’s turnover (178.6 million dollars in 2008), the other part coming from development contracts with the government and revenue granted by public or private funds.

Anthrax

Anthrax is an infectious disease caused by the spore-forming bacterium Bacillus anthracis.

Anthrax most commonly occurs in wild and domestic animals but it can also occur in humans when they are exposed to infected animals or tissue from infected animals.

The disease is transmitted by spores, or contaminated hide, but not from human to human. Cultivation of the bacterium and spores are relatively easy in a laboratory, which makes it an ideal biological weapon.

The company has 600 employees and has been quoted on the New York stock exchange since 2006, with a capitalization of 500 million dollars. Hibri, his family and his management staff keep control of the company with over half of the capital. Emergent has a presence in the United States, United Kingdom, Singapore, China and Germany. And for seven years, between 2000 and 2007, it has experienced uninterrupted growth.

This is partially why the E&Y prize was awarded to Hibri. Other criteria were also taken into account: his ability to inspire his staff, who, he himself acknowledges are “dedicated and motivated”; and his philanthropic involvement in numerous charity organizations, among which the El-Hibri Charitable Foundation, created by his father, that among other things finances the Dar Al-Aytam orphanage in Lebanon.
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www.emergentbiosolutions.com

Thursday, December 10, 2009

Emergent BioSolutions reacts to BARDA's Request for Proposal cancellation

by Nick Rees on December 8, 2009

The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA's Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office's Broad Agency Announcement.

BARDA canceled the RFP for the procurement for rPA vaccines after a technical evaluation panel determined that no proposals submitted by vaccine developers could meet the ProjectBioShield statutory requirement of having the product ready for licensure within eight years.

An amendment issued by BARDA to BAA 09-34 at the same time, however, enable companies to submit proposals to obtain development funding for rPA vaccine candidates, which Emergent has been strongly encouraged to do by BARDA.

Emergent plans to submit its proposal to the BAA by the end of this year, in front of the due date of February 1, 2010 for the proposals.

This announcement also does not impact Emergent's $400 million procurement with the Centers for Disease Control and Prevention to manufacture and deliver 14.5 million doses of BioThrax for the Strategic National Stockpile.

“With this action, BioThrax remains a critical and long-term countermeasure for the US government,” Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, said. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”

BioThrax is currently being delivered under this contract with an expected completion of deliveries by September 2011. BioThrax is the only FDA licensed vaccine for the prevention of anthrax diseases.

“We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost," Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. "BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”

BARDA and Emergent are also in separate talks for a contract that would see BARDAA fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax at Emergent's new 50,000-square-foot Lansing, Mich., manufacturing facility.

"I am proud that Lansing remains home to America's first line of defense against what experts say is the single biggest bioterror threat, anthrax," U.S. Rep. Mike Rogers, MI-08, said. "The good news about the cancellation of this particular proposal is HHS recommitted itself to the Lansing-made anthrax vaccine and has opened a new proposal for a next-generation anthrax vaccine for which Emergent has indicated it will compete.

"Rest assured, I will continue working to strengthen our nation's existing bioterror preparedness measures and protect national security jobs in Lansing."

Bad News Clouds Two Bio Defense Stocks

Written by Staff and Wire Reports
Tuesday, 08 December 2009 01:28


Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.

The two companies which waited until late after hours on Monday to announce that the Biomedical Research and Development Authority had informed them of some negative news.

After hours on Monday, PharmAthene, Inc. (NYSE Amex: PIP) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

PharmAthene was informed of BARDA's decision during a meeting late Monday afternoon with BARDA representatives. BARDA issued a press release after the close of the securities markets announcing that it will cancel RFP BARDA 08-15 because it did not believe vaccine developers submitting proposals in response to the request for proposal (RFP) could have product ready for FDA licensure within 8 years.

In similar news...

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been advised by the Office of the Biomedical Advanced Research and Development Authority (BARDA) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirement of having a product ready for licensure within 8 years.

Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010. During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.

While the decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax® into the Strategic National Stockpile (SNS). Investors are still likely to react negatively to the news.

After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that "BioThrax remains a critical and long-term countermeasure for the US government,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.”


Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-on-these-stocks.html

Saturday, October 17, 2009

October 9, 2008 - Farr Honors Former Santa Cruz Mayor

WASHINGTON, D.C. - R. Scott Kennedy, former mayor of Santa Cruz and co-founder of the city's Resource Center for Nonviolence, was presented with the 2008 El-Hibri Peace Education Prize. This prize, including a check for $10,000, is a joint effort between Nonviolence International, American University and the El-Hibri family. Nancy El-Hibri presented Kennedy the prize honoring his service as a "peace educator and activist of extraordinary impact." The award presentation ceremony highlighted his central role in "establishing and promoting the now cottage industry of educational delegations for peace to Central America and the Middle East." Congressman Sam Farr (D-Carmel), entered a congratulatory statement in the Congressional Record paying tribute to Kennedy. "It is with great pleasure that I call attention to Dr. Scott Kennedy's work to bring peace to the world over the course of his lifetime," Rep. Farr wrote. "He has been a Peace Educator for 40 years and was instrumental in pioneering educational delegations to conflict zones, now a widely practiced form of peace education." During the October 4 award ceremony, Kennedy remarked, "Peace education in the classroom is valuable, yet needs to be complemented with pragmatic, hands-on efforts in our communities to make peace and justice a living reality." He expressed deep appreciation for the many colleagues at the Resource Center for Nonviolence as well as the citizens of Santa Cruz for their tremendous support and inspiration. Mr. Fuad El-Hibri, who established the El-Hibri Peace Education Prize, noted that he and the El-Hibri Charitable Foundation will continue to support the prize and its growth each year in an effort to highlight the importance of peace education, and to support people who are working for a just, peaceful and healthy planet. Kennedy is co-founder of Witness for Peace, the Resource Center for Nonviolence and Interfaith Peacebuilders, which has sent educational around the world to countries whose people suffer from conflict, lack of educational opportunities and social injustice. Source : : http://www.farr.house.gov/index.php?option=com_content&task=view&id=442

Thursday, October 15, 2009

Lebanese CEO Sees Opportunity in Current Crisis

Daily Star

July 10, 2009

http://www.dailystar.com.lb/article.asp?edition_id=1&categ_id=3&article_id=104008
Chairman and CEO Fouad El Hibri insists that good business opportunitiesoften arise in time of crisis, which he considers the best time forentrepreneurs to invest in new projects. "When the market is down, Ibelieve that good opportunities arise and investors have better chancesto find assets that are undervalued and able to provide wonderfulreturns in the future," Hibri told The Daily Star.

"I see within any turmoil great opportunities," he said.

Hibri, an American entrepreneur with Lebanese heritage, is the winner ofErnst & Young Entrepreneur of the Year 2009 Award in the Technologycategory in greater Washington. With great persistence and commitment,Hibri was able to successfully grow a pharmaceutical biotech facilitythat is worth hundreds of millions of dollars and was previously ownedand run by the state of Michigan.

Washington Launched Me, But I am Proud to be a Lebanese Dreaming of New Technology - Al Anwar

By Nihad Tobalian

Lebanese businessman Fuad El-Hibri is the “Entrepreneur of the Year for 2009” for the Washington, DC area, and earned this award from Ernst & Young’s Global Technology Group, which is given to honor businessmen who lead nascent companies to growth in their specialized area of work. He earned this award for leading his American company, “Emergent BioSolutions,” which he transformed from a stumbling company into a pioneer company in the field of development of medical vaccines. What are the details of this award, and the types of vaccines that the 51-year-old El-Hibri has developed?

During a meeting with Anwar, businessman Fuad El-Hibri, who spends his annual vacation in Lebanon, said:

From this award, “Ernst & Young” is seeking major companies that apply quality standards of work and production and the ability to develop new products, against the contribution of these companies in the development and preservation of the community. What helped us as “Emergent BioSolutions” to win this award, specifically for the category of technology in the Washington metropolitan area, is our adherence to the requirement of the award, especially after the recent acquisition of the company, which was for sale for approximately $25 million, and which has 170 employees. Through expansion and development strategy, the price of the company rose to between 400 and 500 million dollars, according to the New York Stock Exchange, as the price per share has risen from six dollars ten years ago to 26 dollars, in addition to increasing the number of employees to 600 employees, which helped us to increase the volume of our business, especially since our approved strategy was also based on a policy of expansion through the acquisition of three money losing companies in the United States, Britain and Germany.

Overseeing Companies

“Ernst & Young,” explains businessman Fuad El-Hibri, “is a global financial company that exercises financial control over companies, and honors those who achieve their aspirations and consequently, their achievements in the creative and innovative areas in the field of technology. After that, a panel of judges selects a ‘Leading Businessman.’ Ernst &Young selected me as the pioneer businessman for 2009 in the field of technology, in my capacity as owner of the company ‘Emergent BioSolutions.’ And while I am proud of the award, I am also proud of every employee in the company, because they all, in addition to being loyal to the company, believe in what we do, and devote themselves to work, especially since the scope of our work requires protecting human life. It is true that the company has a business face, but the primary nature of our work is to protect human life through the development of vaccines that will provide them with immunity against disease. The motto with which we operate the commercial side does not negate the human aspect.”

Oxford University

● You spoke about the specialized vaccines that the company you own develop. What are these vaccines? And against which diseases do they work?
- We are currently working on the development of several new vaccines, including a vaccine for tuberculosis. We, in this regard, are working to develop a special vaccine for this disease, and I can say we are in the advanced stages of testing which we have conducted in South Africa, as we are in the second stage, Phase b, results of which have been encouraging. After two years of testing this vaccine on a sample of children to determine its potency, we have reached the stage of measuring the potency and immunity of the vaccine. If the tests are successful tests, then we will move on to Phase III of the trials to expand the tests to include the category of adults who provide material support for the companies developing the typhoid vaccine. We also receive support from the “Wellcome Trust,” while our partner in these trials is the University of Oxford in the United Kingdom.
The second vaccine—according to El-Hibri—is related to hepatitis B, which would, if successfully tested, provide immunity for patients with this disease. It would also provide a treatment for the chronic diseases resulting from hepatitis B. Businessman Fuad El-Hibri explains, “Patients who suffer from this disease often experience hepatitis B turning into a chronic disease, which may lead, in advanced stages, to liver cancer or liver failure for good. The vaccine, which we are currently developing, helps the patient’s body to protect itself against the disease in terms of reducing and limiting the progress of the disease and limiting its spread in the body. If I were to be optimistic, I would say that this vaccine could eliminate the disease completely, but today, I would say that if we were able to alleviate the pressure of this disease on the patient’s body, then we would have achieved a great result in this area, namely the prevention of the deterioration of the patient’s health. With respect to this vaccine, we have reached the second phase of testing which was conducted on a sample of citizens in China.

A New Medical Development

● What about the work on a vaccine for cancer, for which effective medical treatments have not been found?
- We are working on a number of vaccines for multiple diseases, including for example, work on the development of a vaccine to increase the effectiveness of an old vaccine. For example, there is an effective vaccine for typhoid, but we are working to develop a single dose vaccine, to be administered orally, not with a needle. As for internal diseases, such as internal inflammations for example, we have two technical working groups at the company studying the possibility of trying to find volunteers to receive these vaccines. However, I think it is premature to talk about this vaccine, because we are still in the early stages of the work, and specifically, we are still at the exploration stage. However, in this connection, if we were to look at this issue from a scientific point of view, vaccines are the most advanced in the pharmaceutical industry. Biological studies have shown that vaccines, and immunity enhancement and vaccination are more mature in biological research than they are in the pharmaceutical industry.

● Those who are familiar with your curriculum vitae will find that you specialize in economics. What led you to work in the medical treatment field? - By nature, I love to work on the development of medical treatments. True, I specialized in economics, where I got a diploma from Stanford University and then an advanced degree in business from Yale University, then worked as head of the Operations Department at Citibank Group and then in Hamilton, and both were of consulting nature that encompass different industries, from the financial industry to beverages to research management. After that, I moved to work for consulting firm Booz Allen Hamilton, but above all I love to work on the development of medical treatments, even though I do not have any scientific background in the field of medicine. However, the nature of my work in these institutions and companies helped me to get into this area. In addition, I was lucky to have a wonderful team that helped me and taught me, because the working group has a scientific background and its members are dreamers like me. They have taught me and helped me to penetrate this field.

Friday, August 14, 2009

Emergent BioSolutions Inc., Q2 2009 Earnings Call Transcript

Emergent BioSolutions Inc., (EBS)

Q2 2009 Earnings Call

August 6, 2009 5:00 pm ET


Executives


Robert G. Burrows - Vice President, Investor Relations

Fuad El-Hibri - Chairman of the Board, Chief Executive Officer

R. Don Elsey - Chief Financial Officer

Daniel J. Abdun-Nabi - President, Chief Operating Officer

W. James Jackson, Ph.D. - Senior Vice President and Chief Scientific Officer


Analysts


Eric Schmidt - Cowen & Company

David Moskowitz - Caris & Company

Mona Ashiya - J.P. Morgan

Sean Long – Kennedy Capital Management


Presentation


Operator


Welcome to the Emergent BioSolutions Incorporated second quarter 2009 financial results conference call. (Operator Instructions) I would now like to turn the call over to Mr. Robert Burrows.


Robert Burrows


Good afternoon ladies and gentlemen. My name is Robert Burrows, Vice President of Investor Relations for Emergent. Thank you for joining us today as we discuss Emergent BioSolutions financial results for the second quarter and first six months of 2009. As is customary, our call today is open to all participants. In addition, the call is being recorded and is copyrighted by Emergent BioSolutions.

Joining me on the call this afternoon will be Fuad El-Hibri, Chairman and Chief Executive Officer, and Don Elsey, Chief Financial Officer. Additional members of our senior management team will be present on the call for purposes of the Q&A session.

Before we begin, however, I am compelled to remind everyone that during the all management may make projections and other forward-looking statements regarding future events and the company’s prospects or future performance. These forward-looking statements reflect Emergent’s current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve substantial risks and uncertainties. Actual results may differ materially from those projected in any forward-looking statements.

You are encouraged to review Emergent’s filings with the SEC on Forms 10-K, 10-Q, and 8-K for more information on the risks and uncertainties that could cause actual results to differ.

Emergent BioSolutions Inc. (EBS) CEO & Chairman, 10% Owner Fuad El-hibri sells 15,000 Shares

CEO & Chairman, 10% Owner of Emergent BioSolutions Inc. (EBS) Fuad El-hibri sells 15,000 shares of EBS on 08/11/2009 at an average price of $16.78 a share.

EMERGENT BIOSULUTIONS INC. is a leading biopharmaceutical company dedicated to one simple mission - to protect life. EBS develops manufactures and commercializes vaccines and therapeutics that assist the body\'s immune system to prevent or treat disease. Their products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. Their marketed product BioThrax? (Anthrax Vaccine Adsorbed) is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent BioSolutions Inc. has a market cap of $511.8 million; its shares were traded at around $16.91 with a P/E ratio of 13.1 and P/S ratio of 2.8.

Monday, August 10, 2009

EMERGENT BIOSOLUTIONS INC Profile

Emergent BioSolutions protects your thorax against anthrax. Emergent BioSolutions develops and produces, for government and commercial markets, drugs that treat or protect against infectious diseases and bio-agents. The company supplies BioThrax (the US's only FDA-approved anthrax vaccine) primarily to the departments of Defense and Health and Human Services (HHS). Its biodefense unit is also developing a post-exposure treatment for anthrax and a preventive vaccine for botulinum toxin. For commercial markets, Emergent is working on therapies and vaccines for typhoid, Group B strep, and hepatitis B, among other things. Chairman and CEO Fuad El-Hibri controls more than half of the company....

Friday, August 7, 2009

Fuad El-Hibibri on Business Week

Fuad El-Hibri has been Chairman and Chief Executive Officer of Emergent Biodefense Operations Lansing Inc., a subsidiary of Emergent Biosolutions Inc. since June 2004. Mr. El-Hibri founded Emergent Biosolutions Inc. in 2004 and has been its Chairman and Chief Executive Officer since June 2004. He served as President of Emergent BioSolutions, Inc. from March 2006 to April 2007. He is a successful business entrepreneur with extensive experience in telecommunications and

Fuad El-Hibri on Corridor Inc.

Fuad El-Hibri, chairman and chief executive officer at Emergent BioSolutions Inc., is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region. The awards program recognizes extraordinary innovation, financial performance and personal commitment to a businesses and its community. Emergent BioSolutions, based in Rockville, is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics.

Fuad El-Hibri on Ttiqq

Username: Avatar fuadelhibri
User: Fuad El-Hibri
Homepage: http://www.emergentbiosolutions.com/
Public email: fuadelhibri@aim.com
Location: Rockville, MD

2007 Executive Compensation Report

Fuad El-Hbri
Title:
Chairman and CEO
Company: Emergent BioSolutions
Industry: Biotechnology
Category: Public Companies

2007 Compensation Details

Total Compensation $868,010
Salary $509,100

Emergent Biosolutions’ Typhoid Vaccine Candidate Achieves Endpoints In Phase II Clinical Study

Vaccine well tolerated and immunogenic in double-blind, placebo-controlled study in pediatric population

ROCKVILLE, MD, October 10, 2007— Emergent BioSolutions Inc. (NYSE: EBS) announced today that preliminary results from a recently completed, randomized, placebo-controlled Phase II clinical study demonstrated that its single-dose, drinkable typhoid vaccine candidate achieved the study endpoints for safety and immunogenicity. In this clinical study, which recruited children between 5 and 14 years of age, a total of 101 children received the vaccine candidate and 50 children received placebo. The vaccine candidate and placebo were allocated in a blinded manner. This clinical study, which was conducted in Viet Nam, is the first study of this product candidate in a pediatric population in a region in which typhoid is endemic and was performed in collaboration with Oxford University and the Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam, and financially supported by the Wellcome Trust.

The data from this Phase II clinical study, which is still being analyzed, support the following key findings:

  • The vaccine was immunogenic and met the predefined criterion of an overall immune response rate of greater than 50%, with 95% confidence.
  • The vaccine induced significantly higher antibody concentrations, indicative of systemic responses, in children in the vaccine group compared to the placebo control group.
  • The vaccine was well tolerated with no serious adverse events or deaths reported, and no subjects withdrew due to adverse events.
  • Overall, there were no statistical differences in the incidence of adverse events between the vaccinated and placebo treated groups.

“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.

Previously published studies have shown the vaccine candidate to be immunogenic and well-tolerated. In addition to this Phase II clinical study, the following clinical trials have been completed:

  • An open-label, non-placebo controlled, pilot study conducted in the United Kingdom in healthy adults in which the vaccine candidate was well tolerated and immunogenic, eliciting both cell mediated and humoral immunogenicity.
  • A double-blind, placebo controlled, single dose, dose escalating clinical trial conducted in the United States in which 100% of the trial participants in the highest dose group and 56% of the participants in the lowest dose group had an immune response on the scheduled testing days.
  • An open-label, controlled, single dose clinical trial conducted in the United States in healthy adults to evaluate the safety and immunogenicity of two different presentations of the vaccine. The vaccine candidate was similarly immunogenic in both presentations and both were well tolerated.
  • A single-blind, placebo controlled clinical trial in Viet Nam in healthy adults. The Wellcome Trust provided funding for the trial. The vaccine met the criterion for immunogenicity and was well tolerated, with no serious adverse events reported.

About Typhoid

Typhoid, also known as typhoid fever, is caused by infection with the bacterium Salmonella typhi. Typhoid is characterized by fever, headache, constipation, malaise, stomach pains, anorexia and myalgia. Severe cases of typhoid can result in confusion, delirium, intestinal perforation and death. Typhoid is transmitted by consuming contaminated food or drinks.

Contamination usually results from poor hygiene and sanitation. Typhoid is often endemic in developing countries in which there is limited access to treated water supplies and sanitation.

An estimated 22 million cases of typhoid occur per year worldwide. The Centers for Disease Control (CDC) recommends that all persons from the United States traveling to developing countries consider receiving a typhoid vaccination, with travelers to Asia, Africa and Latin America deemed to be especially at risk. U.S. military personnel deployed in these areas are also at risk of infection.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a 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 biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. 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 clinical trial results and 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 the company’s 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 our products; our ongoing and planned development programs, preclinical studies and clinical trials, including future clinical data for our typhoid vaccine candidate; our ability to identify and acquire or in-license products and product candidates that satisfy our 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 the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 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.

Emergent looks to buy Maryland lab

Emergent BioSolutions Inc. hopes to ramp up production of its anthrax vaccine in Lansing.

The Rockville, Md.-based company said Thursday it plans to sell two unused buildings and purchase a manufacturing facility and laboratory in Maryland.

The pending moves could free up space in Lansing for additional production of BioThrax, the only federally approved anthrax vaccine.

"From a strategic perspective, the new Maryland manufacturing facility broadens our options," CEO Fuad El-Hibri said. Terms of the deals were not disclosed.

Nearly 400 employees work for Emergent in Lansing. About 30 have been hired since the company announced plans to add up to 93 new hires as part of an expansion announced in March that included state tax incentives.

Emergent hopes to ramp up the nation's stockpile of doses for use in case of a biological terrorist attack.

"The government has previously stated they want a stockpile of at least 75 million doses. Our calculations would show the stockpile is way short of that," Chief Financial Officer Don Elsey said.

He wouldn't provide details on the stockpile's shortfall, but said the Department of Defense also draws from the supply.

Emergent currently makes the anthrax vaccine in a Lansing facility with a capacity for roughly 7 million doses a year, Elsey said.

In September, the company will start producing 14.5 million doses as part of a $405 million government contract for the national drug stockpile. It will take two years to complete the contract.

A new $75 million large-scale manufacturing plant in Lansing could handle an additional 30 million doses a year.

The building, completed last year, originally was slated to produce the next-generation anthrax vaccine once it received government approval. But Emergent now is proposing production of the new vaccine be moved to the new Maryland facility, allowing Lansing to make more BioThrax - something that also needs a government OK.

"We have shared with the government our thoughts on this and the new capabilities that this will bring and they are considering it," Elsey said. "It's definitely not something that's firm yet."








Thursday, August 6, 2009

EMERGENT BIOSOLUTIONS ANNOUNCES RESULTS FROM ANNUAL MEETING OF STOCKHOLDERS

Annual Stockholders Meeting Emergent Biosolutions Inc.

ROCKVILLE, MD, June 14, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today the results of the company’s 2007 annual meeting of stockholders, which took place today at the Hyatt Regency Bethesda at 10:00 am Eastern.

There were present, in person or represented by proxy, the holders of more than a majority of the shares of the outstanding common stock of the company, thus constituting a quorum.

Proposal 1—Election of Directors

The following individuals were elected Class I directors of the company to serve for a three-year term expiring 2010: Fuad El-Hibri, Jerome M. Hauer and Ronald B. Richard.

Proposal 2—Ratify Selection of Ernst & Young LLP as the Company’s Independent Registered Public Accounting Firm

The proposal to select Ernst & Young LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2007 successfully passed.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a 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 biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

Fuad El-Hibri -Speaker Life Science Alliances World 2007

Mr Fuad El-Hibri,
Chief Executive Officer and Chairman,
Emergent BioSolutions Inc.

Mr. El-Hibri has served as chief executive officer and as chairman of the board of directors of Emergent BioSolutions since June 2004 and as president since March 2006. Mr. El-Hibri served as chief executive officer and chairman of the board of directors of BioPort Corporation from May 1998 until June 2004, when, as a result of a corporate reorganization, BioPort became a wholly owned subsidiary of Emergent. The Company subsequently renamed BioPort as Emergent BioDefense Operations Lansing Inc. Mr. El-Hibri served as chairman of Digicel Holdings, Ltd., a privately held telecommunications firm, from August 2000 to October 2006. He served as president of Digicel from August 2000 to February 2005. 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 Chief Executive Officer and Chairman of the Board of Directors

Mr. Fuad El-Hibri has served as chief executive officer and chairman of the board of directors since June 2004 and as president from March 2006 to April 2007. Mr. El-Hibri served as chief executive officer and chairman of the board of directors of BioPort Corporation from May 1998 until June 2004, when, as a result of our corporate reorganization, BioPort became a wholly owned subsidiary of Emergent. We subsequently renamed BioPort as Emergent BioDefense Operations Lansing Inc. Mr. El-Hibri served as chairman of Digicel Holdings, Ltd., a privately held telecommunications firm, from August 2000 to October 2006. He served as president of Digicel from August 2000 to February 2005.
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.

Local Fuad El-Hibri Named EY Entrepreneur of the Year

Ever since the dot-COM bubble burst almost ten years ago, Maryland has been bragging about how biotech would not only become the next big thing in innovation and business but would put Maryland on the map. Well, while it has mostly been hyperbole, Rockville, Maryland, based Emergent BioSolutions has been the bright-burning exception under the leadership of Chairman and CEO, Mr. Fuad El-Hibri. Well, Ernst & Young has named Fuad El-Hibri the Ernst & Young Entrepreneur of the Year 2009

Fuad El-Hibri on Backtype

Fuad El-Hibri

Name
Fuad El-Hibri
Web
www.emergentbiosolutions.com
About Me
Mr. Fuad El-Hibri is the Chairman and Chief Executive Officer of Emergent BioSolutions Inc. (Emergent).

Fuad El-Hibri discusses challenges of marketing overseas

BioPort is the only FDA-licensed producer of the anthrax vaccine.

Fuad El-Hibri, chairman and CEO of Emergent BioSolutions Inc., speaks March 9 in Sage Hall. Kevin Stearns/University Photography

On March 9, MBA students taking International Political Risk Management, a course taught by Elena Iankova, a lecturer at the S.C. Johnson Graduate School of Management, heard Fuad El-Hibri, chairman and CEO of Bioport’s parent company, Emergent BioSolutions Inc., discuss the hurdles his firm faces in making and marketing its products abroad.

His guest lecture was titled “Managing International Risk in the Bio-Defense and Telecommunications Industries.”

Using his own company as an example, El-Hibri outlined six areas of risk in international business, among them export/import regulations, politics at home and abroad and financial issues. Much of his talk focused on political issues ranging from export regulations to how to deal with foreign governments.

One hurdle: when BioPort sought to export its anthrax vaccine, BioThrax, the U.S. Department of Defense claimed the vaccine was primarily of military importance and should therefore fall under International Traffic in Arms Regulations (ITAR). Under ITAR, export of the vaccine is controlled by the Department of State and a license is required for each sale. BioPort succeeded in arguing that its product was non-military in nature and therefore belonged under Export Administration Regulations (EAR). Exportation under EAR is controlled by the Department of Commerce and has far fewer restrictions.

El-Hibri seemed to take such challenges in stride. “Obviously,” he said, “the U.S. government is interested in vaccines, especially bio-defense vaccines.” It controls which countries vaccines can be exported to and may use them as a bargaining chip in its own deals with foreign ministries of defense, he commented. “They like to throw our vaccine into the mix and say, ‘Listen, if you buy one more tank or one more fighter jet … we’ll throw in 10,000 doses of anthrax vaccine,’” he said. But such giveaways create problems for companies like BioPort by reducing demand for its products in foreign countries.

Some uncontrollable variables that affect the demand for vaccines are: Politics within the foreign country, the country’s relationship with the United States, its finances, its fears about external threats and regional geopolitics, noted El-Hibri.

He also repeatedly mentioned the importance of having local connections. “It is critical that you appoint or partner up with a local distributor,” he stressed. A local partner can help businesses stay abreast of the political situation and provide valuable insight into local culture and customs, he said, noting that acceptable business practices often vary widely between countries.

For example, in many countries it is common practice for businesses to offer bribes or gifts to government officials in return for their assistance, he commented. But under U.S. law, it is illegal for American companies to do so, with stiff penalties for violations. While the restriction can be circumvented by giving small gifts, under $25 in value, a better policy is to avoid gifts altogether, said El-Hibri, and instead get close to decision makers by developing relationships with them, helping them solve some of their problems.

He also stressed that the media can be either an important ally or a formidable enemy. “Many of our competitors aren’t as media savvy as we are and that gives us an edge.”

Iankova later said of El-Hibri’s talk: “I was impressed because he’s put a lot of effort into addressing exactly the issues we addressed in class. [It was] very helpful for my students.”

Gligor Tashkovich ‘87, MBA ‘91, who worked with El-Hibri in the telecommunications industry and helped to organize his visit to campus, called him “a brilliant businessman and entrepreneur.”

And Herb Lara, MBA ‘06, president of the Health Care and Biotechnology Club, a student group at the Johnson School, enjoyed having the opportunity to hear El-Hibri speak. “Bio-defense is something that’s not a widely available topic for discussion, so it was definitely a big deal to have someone of his stature come here to talk to us,” he said.

Before entering the biopharmaceutical industry 15 years ago, El-Hibri worked at Citicorp and Booz Allen & Hamilton.

Courtney Potts is an intern with the Cornell News Office.

Peace Prize awarded to Center for Nonviolence’s Kennedy

Scott Kennedy, cofounder and staff member of the Resource Center for Nonviolence, will receive the 2008 El-Hibri Peace Education Prize the first week of October in Washington, DC. The annual prize is given by the El-Hibri family, Nonviolence International, and the International Peace and Conflict Resolution program at American University.

In a letter notifying Kennedy tha he had been selected to receive the prize, Mubarak Awad, founder and director of Nonviolence International in Washington, DC, cited Kennedy’s “outstanding achievements as a peace educator,” including his role in co-founding and leading the Resource Center for Nonviolencce, work with the Fellowship of Reconcilation, and promoting the practice of peace education tours to the Middle East other parts of the world. Awad commented that together these activities “highlight a tremendous legacy of peace education, for which we are proud to recognize you with this prize.” Mr. Fuad El-Hibri established the El-Hibri Peace Education Prize in 2007 to honor individuals who have dedicated their lives to peace education in their community. The first prize was given to Professor Abdul Aziz Said of American University for his 50 years of teaching and advocating for peace through peace education…..