“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

“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 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 Inc. (NYSE:EBS) is hosting “Bioterrorism Prevention, Preparedness and Response,” a forum organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA) to raise global awareness of the importance of biopreparedness. The visiting delegation is composed of parliamentarians from Canada, Estonia, France, Finland, Germany, Greece, Italy, Hungary, Lithuania, the Netherlands, Norway, Romania, Poland, Portugal, Turkey, Sweden, Slovenia, Spain, and the United Kingdom.

“Emergent commends NATO parliamentarians for advancing the international dialogue on biopreparedness,” said Allen Shofe, senior vice president public affairs, Emergent BioSolutions. “We are pleased to share our knowledge based on Emergent’s extensive experience in the development, manufacture, and delivery of medical countermeasures that are critical to the U.S. government’s biodefense infrastructure.”

The forum features biodefense expert Dr. Robert Kadlec, Director of PRTM Biodefense and Public Health Practice, who will discuss the United States’ approach to bioterrorism prevention, including best practices and strategies such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

Emergent BioSolutions’ senior management team, headed by Daniel J. Abdun-Nabi, President and Chief Operating Officer, Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services, and Dr. Barry Kellman, President of the International Security and Biopolicy Institute (ISBI) are among the attendees. The forum is taking place in Washington, D.C.

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.

About the NATO Parliamentary Assembly

The NATO Parliamentary Assembly is the inter-parliamentary organization of legislators from the member countries of the North Atlantic Alliance as well as 14 associate members. The Assembly provides a critical forum for international parliamentary dialogue on an array of security, political and economic matters. For more information, visit www.nato-pa.int.

“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.

• The Jefferies & Company 2010 Global Life Sciences Conference
  New York, NY.
  June 8, 2010
  Corporate Overview Presentation
  11:00 AM Eastern
  There will be a full webcast with slides that will include discussion of the Company’s business activities, financial outlook and current news.

• The Needham & Company 9^th Annual Healthcare Conference
  New York, NY.
  June 10, 2010
  Corporate Overview Presentation
  3:20 PM Eastern
  There will be a full webcast with slides that will include discussion of the Company’s business activities, financial outlook and current news.

Both webcasts will be accessible from the Emergent website www.emergentbiosolutions.com under “Investors”.

“It is an honor to represent Emergent BioSolutions, a company composed of talented and hardworking individuals committed to the corporate mission of protecting life,” said Fuad El-Hibri, chairman and chief executive officer, who received the award on behalf of the company.

Fuad El-Hibri Accepts the 2010 Tech Council of Maryland Biotechnology Firm of the Year Award

For 22 years, TCM has recognized companies that have helped establish Maryland’s thriving technology community.  This year’s theme “Building Something Great Together” focuses on the tremendous growth and future outlook for the technology community.

“The theme, ‘Building Something Great Together,’ is meaningful because Emergent’s success is built on teamwork and collaboration,” Mr. El-Hibri continued.  “It also acknowledges the role that businesses play in contributing to the State’s economic and job growth.  Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.”

The criteria for the Biotechnology Firm of the Year Award include: achieving significant and measurable success, contributing to the advancement of biosciences through cutting-edge research and development, crisply executing a growth strategy, and helping foster a vibrant biotech community.

TCM is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM’s mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody 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 approved by the U.S. Food and Drug Administration for the prevention of anthrax disease.  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

“Strengthening the Biological Weapons Convention and international cooperation in biodefense are of paramount importance. This forum organized by Emergent is extremely valuable in helping us, as national legislators, to obtain more information on biopreparedness and to promote the idea of strengthening national biodefense capabilities using the best practices and expertise developed by our Allies,” said Canadian Senator Pierre Claude Nolin, NATO PA Treasurer and Vice Chairman of the NATO PA Science and Technology Committee. “We are firm believers in international mechanisms to address bioterrorism challenges.”

The forum is to provide an overview of the United States’ approach to bioterrorism prevention, the role of the Department of Defense and the importance of coordination of international efforts. Featured speakers include: Congressman Mike Rogers (R-MI), Dr. Robert P. Kadlec, Director of PRTM Biodefense and Public Health Practice, Jim Saxton, former Member of the U.S. House of Representatives, and Dr. Tevi Troy, Senior Visiting Fellow at the Hudson Institute and former Deputy Director of the U.S. Department of Health and Human Services.  The visiting delegation, led by NATO Officers of the Science and Technology Committee, is composed of parliamentarians from representative NATO nations including Canada, the Czech Republic, France, and Portugal. The forum is taking place in Washington, D.C.

Mr Fuad El-Hibri and to his right Rep. Chris Van Hollen (D-MD)

ROCKVILLE, Md., Mar 11, 2010 (BUSINESS WIRE) — Emergent BioSolutions Inc. (EBS 15.96, -0.03, -0.19%) announced today that Fuad El-Hibri, its chairman and chief executive officer, has been named by the World Trade Center Institute (WTCI) as one of Maryland’s outstanding international business leaders. Celebrating the spirit of global ambition and excellence in international leadership, WTCI presents the Maryland International Leadership Awards annually to leaders within the state who exemplify entrepreneurial spirit, innovation, and global reach.

Mr. El-Hibri stated, “Across the globe and on a daily basis, the Emergent team lives out the company mission of protecting life – a commitment to make meaningful contributions to address unmet medical needs especially in underserved markets. It is an honor to be recognized for the work that we do and to receive this award on behalf of the team.”

“Mr. El-Hibri recognizes the importance of global markets as key to future growth. WTCI is pleased to showcase Mr. El-Hibri and Emergent BioSolutions’ many achievements and is honored to name him as one of Maryland’s 2010 International Business Leadership Award winners,” said Deborah M. Kielty, president and executive director of the World Trade Center Institute.

WTCI was established in Baltimore in 1989 as a non-profit membership organization to help connect Maryland to the globe. It is the region’s premier private sector international business partner and a member of the World Trade Center Association, a family of 300 centers located in vibrant business communities around 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(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.

SOURCE: Emergent BioSolutions Inc.

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

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.
—

www.emergentbiosolutions.com

Fuad El-Hibri

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.”

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

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….

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…..

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.

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.

Posted by Chris Abraham at 8:33 AM

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.