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Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine

September 10th, 2010 admin No comments

New Contract Valued at up to $28.7 Million for Phase II Clinical Trial

ROCKVILLE, Md., Sep 01, 2010 –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate. The award of this contract increases to over $58 million the total potential development funding from NIAID for this product. This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmuneTM).

“Emergent applauds the U.S. government’s commitment to protecting the nation against biological threats by supporting critical development of advanced vaccine and therapeutic candidates,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”

This four-year development contract consists of a two-year base, valued at $9.1 million, and milestone-based options that if exercised, would increase the total contract value to up to $28.7 million. The base contract will fund activities related to manufacturing and stability studies of Phase II clinical trial lots, process characterization and assay validation, and clinical trial preparation. The milestone-based options include continued stability testing of Phase II clinical trial lots and a clinical study to evaluate safety and immunogenicity of the product candidate. The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.

This new contract was awarded to expand the development efforts being conducted under a Biomedical Advanced Research and Development Authority (BARDA)/NIAID contract awarded in September 2008, which provides for funding of up to $29.7 million. Thus, with this new contract, the potential funding from the U.S. government for this third generation anthrax vaccine candidate increases to over $58 million.

About Emergent BioSolutions Inc.
Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s 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. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.Additional information may be found 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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, 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 ongoing and planned preclinical studies and clinical trials; our plans to pursue label expansions and improvements for BioThrax(R); the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 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 Revises Upward 2010 Financial Forecast

August 3rd, 2010 admin No comments

Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it is revising upwards its 2010 annual guidance to now reflect anticipated total revenues of $275 to $300 million and net income of $40 to $50 million.  Of the anticipated total revenues of $275 to $300 million, $165 to $190 million is expected to be recognized in the second half of 2010.  This revised forecast does not reflect or incorporate any revenue impact from a possible development contract for the company’s rPA vaccine candidate. The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax® procurement contract with the US Centers for Disease Control and Prevention (CDC).  This contract modification increased the number of doses of BioThrax that the company can deliver into the Strategic National Stockpile (SNS) during calendar 2010.  This increased volume of available doses of BioThrax is due to consistently high production yields throughout 2010. “This modification by the CDC to our existing BioThrax procurement contract reinforces, yet again, the US government’s commitment to BioThrax as a critical component of the Strategic National Stockpile and to our nation’s defense against bioterrorism,” said Fuad El-Hibri, chairman and chief executive officer of Emergent.  “This is another example of how we continue to work with our US government partners in establishing BioThrax as the backbone of our readiness against the threat of anthrax and to building a stockpile as rapidly as possible.” Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, also commented, “The production yields we have been experiencing are a direct result of our commitment to driving innovation in our manufacturing process and to a multi-year initiative focused on process optimization of the existing Building 12 production facility.  We are extremely pleased with the results of our continuous process improvement program for BioThrax and expect this program to drive the maintenance of positive production metrics going forward.”

About Emergent BioSolutions Inc. Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease.  Emergent’s 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’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.  Additional information may be found at www.emergentbiosolutions.com.

About BioThrax® BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection.  It is indicated for the active immunization of adults who are at high risk of exposure to anthrax.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis.  Since 1998, the U.S. government has procured over 45 million doses of BioThrax.  During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our manufacturing success rates; 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 March 31, 2010 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.

Maryland Governor Martin O’Malley Leads Ribbon Cutting Ceremony at Emergent’s Baltimore Manufacturing Facility

July 27th, 2010 admin No comments

ROCKVILLE, MD, July 16, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) today held a ribbon cutting ceremony, led by Governor Martin O’Malley and Fuad El-Hibri, Emergent’s chairman and chief executive officer, to mark the formal opening of Emergent Manufacturing Operations Baltimore.  Emergent’s new facility consists of 56,000 square feet of manufacturing and office space, and includes multiple manufacturing suites designed to support clinical and commercial manufacture of the company’s rPA, anthrax monoclonal, and tuberculosis product candidates, among others.

“The Baltimore facility symbolizes Emergent’s continued investment in manufacturing as one of its core competencies and competitive advantages,” said Mr. El-Hibri.  “It is also a testament to Emergent’s commitment to the State of Maryland, where we are proud to be a key contributor to economic development and job growth.”

“Maryland has a reputation of being a haven for thriving life sciences and biotechnology companies, thanks to industry leaders like Emergent BioSolutions,” said Governor O’Malley. “Emergent’s expansion into Baltimore, through the purchase and re-commissioning of this facility, enables significant investment in the biotech infrastructure already in place and ensures that high-paying, highly-skilled jobs are created and remain in Maryland.”

Emergent employs over 680 employees across the globe, with 180 employees located in Maryland, where, aside from the Baltimore manufacturing facility, its corporate headquarters and one of its product development sites are located.  The opening of this new facility could create an additional 120 jobs in the next five years.

“The opening of this new biopharmaceutical facility is good news for three reasons: jobs, jobs and more jobs for Maryland,” said Senator Barbara Mikulski (MD-D). “To keep our state competitive in the global economy, we have to create and support Maryland’s jobs of the future, like the innovative life sciences jobs at Emergent BioSolutions. I’m proud that East Baltimore has been selected to house a facility dedicated to research that will keep Americans healthy and safe.”

Maryland Governor Martin O'Malley and Fuad El-Hibri

Maryland Governor Martin O'Malley and Fuad El-Hibri

“I’m pleased to welcome Emergent BioSolutions to Baltimore,” said Congressman John Sarbanes (MD-D).  “This manufacturing facility helps Maryland maintain its status as a leader in the bioscience industry and brings more than 100 high paid, high skilled jobs for Marylanders.”

“Baltimore City is excited about Emergent BioSolutions’ decision to invest here, which will create many jobs and contribute a great deal to the Baltimore biotech industry,” Baltimore Mayor Stephanie Rawlings-Blake said.  “I welcome Emergent BioSolutions to Baltimore City and look forward to the company’s growth in one of Baltimore’s key industries.”

The company is currently working on modifying and re-commissioning the facility.  Planned facility modifications will allow for the utilization of disposable manufacturing technology to potentially result in lower capital investments, lower operating costs, and accelerated process development timelines.  The facility previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization to produce a number of products approved by the FDA and the European Medicines Agency.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s 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’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found 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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; 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 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 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 BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax

July 15th, 2010 admin No comments

ROCKVILLE, Md., Jul 14, 2010

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax(R) (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

“In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations.”

This cost plus fixed fee development contract has a total value of $107 million and consists of a two-year base period of performance valued at $54.6 million and three option years that, if exercised by BARDA, would increase the contract value to up to $107 million. Under the contract, the company anticipates recognizing revenues of up to $10 million and pretax earnings of up to $5 million during the second half of 2010. A substantial majority of the value of the $107 million contract will be realized in the first three years of performance (July 2010 to July 2013), assuming exercise of the first option year.

The contract award is based on a technical proposal provided to BARDA that projects an annual large-scale manufacturing capacity of 26 million doses in Building 55. This is a significant increase from the company’s current capacity of approximately 7-8 million doses per annum.

The company has developed a comprehensive plan to demonstrate comparability between the current manufacturing process and the large-scale manufacturing process for BioThrax. The contract will fund activities related to process validation, assay validation, fill/finish, and if required, non-clinical and clinical studies. The plan also includes regulatory activities in support of the submission to FDA of a supplemental Biologics License Application (sBLA) for BioThrax at the expanded scale. The company expects to begin manufacturing consistency lots as early as the fourth quarter of 2011.

Emergent has invested significant resources in Building 55, which has been designed to manufacture up to 25 to 30 million doses of BioThrax as currently configured, and is expandable by adding a second manufacturing train that would double annual capacity, based on demand. This is aligned with the company’s core strategy to enhance its manufacturing capabilities to meet the increasing government demand for anthrax vaccines for inclusion in the SNS.

The company also continues to enhance the attractiveness of BioThrax as a significant component of the SNS, most recently through FDA approval of extended shelf life to four years. In addition, based on data from a seven-year study by the Centers for Disease Control and Prevention, the company has submitted to FDA an sBLA to further reduce the BioThrax vaccination schedule to three doses within six months with triennial booster vaccinations. To date, Emergent has supplied over 42 million doses of BioThrax to the U.S. government with additional deliveries scheduled through the third quarter of 2011 pursuant to the current procurement contract with HHS.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s 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. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

About BioThrax

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax. During that time period, more than 9.6 million doses have been administered to nearly 2.4 million military personnel. For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

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, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax(R) procurement; our ability to obtain new BioThrax(R) sales contracts; our plans to pursue label expansions and improvements for BioThrax(R); our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; 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 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 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 BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments

July 7th, 2010 admin No comments

ROCKVILLE, MD, June 24, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) led by CEO Fuad El-Hibri,announced today that it has completed separate international sales and deliveries of BioThrax® (Anthrax Vaccine Adsorbed) to governments of several allied nations.  The company’s international sales efforts have resulted in these sales of an undisclosed number of BioThrax doses for aggregate revenue of approximately $2.3 million in the second quarter.

“Emergent recognizes that governments play a key role in protecting citizens against the growing threat of bioterrorism,” said Allen Shofe, senior vice president public affairs of Emergent BioSolutions.  “As the maker of the only U.S. FDA-licensed anthrax vaccine, and in line with our corporate mission to protect life, we are honored to support such biopreparedness efforts of allied international governments.”

About BioThrax

BioThrax is the only U.S. FDA-licensed vaccine for the prevention of anthrax infection.  It is indicated for the active immunization of adults who are at high risk of exposure to anthrax.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured over 42 million doses of BioThrax.  During that time period, more than 9.5 million doses have been administered to nearly 2.4 million military personnel.  For full prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Safety Information for BioThrax®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease.  Emergent’s 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’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia.  Additional information may be found 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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2010, 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 appropriations for BioThrax® procurement; our ability to obtain new BioThrax® sales contracts; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 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.

500 Most Influential Muslims: Science and Technology

January 6th, 2010 admin No comments

The Prince Alwaleed Bin Talaal Center for Muslim-Christian Understanding and The Royal Islamic Strategic Studies Centre published its first edition in what promises to be an annual series of insight into the movers and shakers of the Muslim world. Entitled The 500 Most Influential Muslims 2009, the book categorizes Muslims’ influential capacities into 15 categories: scholarly , political, administrative, lineage, preachers, women, youth, philanthropy, development, science and technology, arts and culture, Qu’ran reciters, media, radicals, international Islamic networks and issues of the day. As part of an ongoing series each week those receiving mention in North America will be highlighted. This week those who seem to have influence in Science and Technology will be highlighted. In this category, there are four people honored living in the United States.

Mohamad Chakaki is a founding member of Green Muslims, a Washington, D.C. group that seeks to relate sustainable environmental policy to faith. He works on projects in the US and the Middle East.

Fuad El Hibri is the CEO of Emergent BioSolutions, Inc. BioSolutions is a multinational bio-pharmaceutical company that is the sole-holder of the FDA-approved anthrax vaccine. He is also Chairman of the East West Resources Corporation and Chairman and Treasurer of the El Hibri Charitable Foundation.

Dr. Mehmet Oz is a cardiothoracic surgeon recently named one of the sexiest men alive for 2009. A frequent visitor of the Oprah Winfrey show and now host of his own show, he is a professor at Columbia University and leads numerous charities and organizations. He has authored several books on personal health.

Ahmed Zewail is the recipient of the 1999 Nobel Prize in Chemistry for his research on femotochemistry. He is the Linus Pauling Professor at the California Institute for Technology and was recently asked to serve at President Obama’s invitation as an adviser to the Presidential Council of Advisors on Science and Technology.

For more info: IBSN: 2009-9-4078

Source :
http://www.examiner.com/x-26018-SE-Michigan-Islamic-Examiner~y2009m12d27-500-Most-Influential-Muslims-Science-and-Technology?cid=edition-rss-Detroit

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Maker of anthrax vaccine discusses challenges of marketing overseas

August 4th, 2009 admin No comments

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.

http://www.news.cornell.edu/Chronicle/05/3.17.05/El-Hibri.jpg

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.

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Fuad El-Hibri Ernst & Young Entrepreneur of the Year 2009 Award Finalist

July 6th, 2009 admin No comments
Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Finalist in Greater Washington

ROCKVILLE, Md.–(BUSINESS WIRE)–Emergent BioSolutions Inc. (NYSE:EBS) announced today that its chairman and chief executive officer, Mr. Fuad El-Hibri, is a finalist for the Ernst & Young Entrepreneur of the Year® 2009 Award in the Greater Washington region. According to Ernst & Young LLP, the awards program recognizes entrepreneurs who demonstrate extraordinary success in the areas of innovation, financial performance and personal commitment to their businesses and communities. Mr. El-Hibri was selected as a finalist from nearly 100 nominations by a panel of independent judges. Award winners will be announced at a special gala event on June 18 at the Ritz-Carlton, Tysons Corner in Virginia.

“It is an honor to be chosen as a finalist for the Ernst & Young Entrepreneur of the Year Award,” said Mr. Fuad El-Hibri. “I am proud of the entrepreneurial spirit, commitment, and collaboration that prevail at Emergent, which are key factors to our company’s success. This recognition represents the contributions of each and every member of the Emergent Team as we work together in pursuit of our company mission – to protect life.”

Mr. El-Hibri was also a finalist for the Greater Washington region in 2007. The Ernst & Young Entrepreneur of the Year awards program celebrates its 23rd anniversary this year. The program has expanded to recognize business leaders in over 135 cities in 50 countries throughout the world.

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 www.emergentbiosolutions.com.

About Ernst & Young’s Entrepreneur of the Year® Awards Program
Ernst & Young’s Entrepreneur of the Year® Award is the world’s most prestigious business award for entrepreneurs. The award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, the Ernst & Young Entrepreneur of the Year® award celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 135 cities in 50 countries.

Sponsors
Founded and produced by Ernst & Young LLP, the Entrepreneur of the Year awards are pleased to have the Ewing Marion Kauffman Foundation and SAP America as national sponsors.

In Greater Washington, sponsors include HSBC Bank, Pillsbury Law, Reznick Group, Lockton Companies and the Washington Business Journal.

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Muslim CEO Fuad El-Hibri of U.S. firms fight terrorism, ’stop evil’

July 6th, 2009 admin No comments
ROCKVILLE, Md. — Those who go to sleep at night with the threat of terrorism on their minds might be surprised to learn that Muslim CEOs are running companies that watch over our safety.

Fuad El-Hibri is CEO of BioPort, the only U.S. maker of anthrax vaccine.

• Houssam Salloum is CEO of Axiolog, a Detroit firm developing a high-tech system for tracking international cargo into vulnerable U.S. ports.

• Nafa Khalaf is CEO of Detroit Contracting, which after the Sept. 11 attacks in 2001 secured the five major treatment plants that supply water to 4.5 million residents of the Detroit area. Khalaf, 50, emigrated from Iraq in 1986, and his company is now working to protect water plants in Iraq.

• Ahmad Mesdaq, owner of businesses in San Diego including a coffee lounge and cigar factory, this summer will launch an auto registration system in his native Afghanistan that will help authorities stop widespread shipments of explosives and drugs by warlords. Getting Afghanistan back on its feet brings security to the USA, he says.

The past three years have shown the war on terror is complicated. Just as sides can’t be drawn up by national boundaries, neither can the good guys and bad guys be identified based on their religion or national origin.

Throughout history corporate executives have played important roles in winning wars. President Franklin Roosevelt made Robert Wood Johnson, the late CEO of Johnson & Johnson, an Army general in World War II and put him in charge of bringing small business into the war effort. Executives will likely play a critical role in the war on terrorism as well. But they won’t all have names like Johnson. Some may have names like El-Hibri or Mesdaq.

“American Muslims are making endless efforts to stop evil,” Mesdaq says.

These executives are the antithesis of the celebrity CEO so common now in Corporate America. After all, these are times when Muslims running companies in homeland security could attract the attention of both Islamophobes and terrorists. It took months of searching trade associations, chambers of commerce and homeland security experts for USA TODAY to find a cadre of companies that contribute to the security of the U.S. and have a Muslim at the helm. When found, some said they were under contractual obligations not to talk to the media. Some, like Salloum, declined to be interviewed so as not to attract attention. Others were like El-Hibri, who agreed to an interview with reservation.

“Some successful business people in the Muslim community are worried that there are forces working against them,” he says, sitting in his office tucked away in a building with no exterior signage in this Washington, D.C., suburb.

“I’m trusting, not paranoid,” says El-Hibri, 46, who became a U.S. citizen in 1999. He was born in Germany and spent his childhood equally in Europe and the Middle East before coming to the USA to get an economics degree from Stanford and an MBA from Yale. “But there is a group who don’t think the anthrax vaccine should be in the hands of someone with an Arab or Muslim background.”

Scrutiny surrounds anthrax vaccine

Conspiracy-theory Internet sites have taken a special interest in El-Hibri’s formative years in Lebanon and Sudan, and a more recent three-year assignment in Saudi Arabia with Citibank. The sites imply crimes ranging from ties to Osama Bin Laden to being the mastermind behind the mailing of anthrax spores that killed five people in 2001. El-Hibri calls the Web sites annoying and jokes that he’s lucky to be in the vaccination business so that he can inoculate himself from the pain of accusers who can’t be confronted.

Even some members of Congress have objected to BioPort’s anthrax role. That criticism reflects ignorance, says retired admiral William Crowe, who served as chairman of the Joint Chiefs of Staff in the Reagan administration and the first George Bush administration and now is on BioPort’s board of directors. BioPort recruited Crowe, a friend of El-Hibri’s father. Crowe received 8% of BioPort’s stock to serve on its board, largely because of his expertise about the key customer, the Defense Department. But Crowe’s presence also mitigates the attention on El-Hibri.

BioPort keeps a small supply of anthrax spores under five layers of security to verify the potency of the vaccine, a requirement of the Food and Drug Administration. That makes El-Hibri a suspect of conspiracy theorists, who say the unsolved anthrax mail crime of 2001 increased demand for BioPort’s product while El-Hibri and his family were safely inoculated from the fatal bio-threat.

“That’s a terrible stretch,” says Crowe, who says El-Hibri is straightforward and honest and is one who has “never entertained even the slightest idea of fooling the government” and “bends over backward to make sure the Defense Department is aware.”

Muslim executives were careful and measured when responding to most questions but became noticeably uneasy when asked how devout they were to Islam. A typical response: “I attend mosque when I have time,” Khalafsaid. “My philosophy is to be good, to live with others and to be equal with others.”

“I don’t drink alcohol or gamble,” said Mesdaq, 32. “I go to mosque,” but he emphasized: “I’m not a political Muslim. I’m a normal American. I like to drive nice cars, go out and have fun and dance. I’m very blessed.”

El-Hibri says he attends mosque once a year. His mother is German and Catholic. He adopted the faith of his Lebanese father. Islam, Christianity and Judaism are essentially the same, El-Hibri says, with a “belief in one God, what’s right and what’s wrong. Do the best things in the eyes of God, that’s most important.”

That there are Muslims fighting terrorism comes as no surprise to Daniel Lubetzky, the Jewish CEO of Peaceworks, a New York company that fosters joint ventures in regions of conflict. For example, Peaceworks markets Meditalia food products made in cooperation among Israelis, Palestinians, Egyptians and Turks; and Bali Spices made by Muslims, Buddhists and Christians working as partners in Indonesia.

Lubetzky finds that business leaders are usually moderates who see extremism as the enemy to solving poverty. The majority of Muslims have the most to lose from terrorism, because the moderates always pay for the backlash against the extremists, Lubetzky says. “Terrorists hurt their own people the most.”

Making Afghanistan safer helps the USA

Mesdaq is the son of a brigadier general in the Afghani air force who immigrated to the USA as a 9-year-old after the Soviet Union invaded Afghanistan. After the Sept. 11 attacks and the subsequent U.S. war in Afghanistan, he returned a year ago to his native country to visit family. He found a country with more than 500,000 vehicles and no efficient system of registration and licensing. SUVs with tinted windows and diplomatic plates from Iran, Pakistan and the former Soviet republics are everywhere,loaded with explosives or drugs and driven by warlords, he says.

Mesdaq had an idea for a registration system using license plates with holograms. The U.S. State Department approved his plan last month, and he says it will be launched this summer. A one-time registration fee of $100 a car will generate $50 million for the country.

Mesdaq says it’s important that Afghanistan not become dependent on aid from the U.S. “They need to lift themselves if they love their country,” he said.

Salloum is a former captain for the Italian merchant marine who left Lebanon at 17. He has lived in the USA since 1998 and is developing a tracking system that uses satellites to monitor U.S.-bound cargo.

Under the present system, if authorities become suspicious about U.S.-bound cargo, the U.S. Coast Guard boards the arriving ship six miles out at sea, checks the paperwork and, if necessary, examines individual crates. The Axiolog system aims to let enforcement agents worldwide use intelligence more efficiently to flag questionable shipments.

For example, a shipment of books might be inspected if Axiolog finds no record of that company ever receiving paper to publish books. Axiolog would allow such anomalies to be examined by computer while the cargo is en route, cutting down on expensive delays to legitimate shipments.

Such a system could prove invaluable. Even the threat of a dirty bomb could close the port of Los Angeles for a week. It would then take nearly two months to clear the backlog of incoming ships, economic terrorism that could cost billions of dollars.

El-Hibri says it’s a myth that a belief in Islam interferes with being good in business. A study last year by Marcus Noland at the Institute for International Economics supports El-Hibri’s position. Noland found no evidence that Islam was a drag on economic development in countries with large Muslim populations — outside of oil-rich regions where extremist views often interfere with education.

“The Islamic religion promotes hard work and the idea that there’s nothing wrong with being a financial success as long as you do it in an ethical and moral way,” says El-Hibri, an avid polo player whose father’s company built telecommunication networks in Saudi Arabia, Russia, Poland, Venezuela and El Salvador.

Khalaf, who took just 18 months to get a civil engineering degree from Wayne State University when he came to the USA in 1986, then earned an MBA from George Washington University, agrees that Muslim executives have their priorities straight.

“When you become an American citizen your priority is to protect Americans,” he says.

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Fuad El-Hibri discusses challenges of marketing overseas

July 6th, 2009 admin No comments

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.

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