Fuad El-Hibri Wire

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.

The El-Hibri Foundation is a nonprofit organization with the goal of fostering dialogue between various religions and encouraging nonviolent solutions to global challenges affecting humankind.  The Foundation has a new website at www.elhibrifoundation.org.

The Foundation, lead by Chairman of the Board of Trustees Fuad El-HIbri, is divided into four different initiatives: The Peace Education Initiative, The Interfaith Dialogue Initiative, The Humanitarian Aid Initiative, and The Social Justice Initiative.

Fuad El-Hibri awards the 2009 Peace Education award

The Peace Education Initiative focuses on conflict resolution, embracing cultural diversity, and supporting cross-cultural approaches to peace-building.  The Interfaith Dialogue Initiative focuses on supporting understanding between the three Abrahamic faiths: Islam, Judaism and Christianity.  The Humanitarian Aid Initiative provides grants to organizations that aim at delivering education and medical care to the disadvantaged.  The last of the four initiatives is the Social Justice Initiative.  The Social Justice Initiative addresses issues of equality, justice and human rights, especially for women and children.

The El-Hibri Foundation promotes these four initiatives through the provision of grants.  Since its creation in 2001, the Foundation has given away 36 grants totaling over 8.2 million dollars.

For more information on the El-Hibri Foundation visit their website:  www.elhibrifoundation.org

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.

Fuad El-Hibri, CEO of Emergent BioSolutions Inc., announces that the company will be participating in the following investor conferences during June 2010:

• 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”.

ROCKVILLE, MD, May 13, 2010 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland’s (TCM) Annual Tech Awards.  This award acknowledges the company that best exemplifies the spirit of Maryland’s biotechnology community as well as its presence and leadership within the state.

“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.

Emergent BioSolutions’ senior management team, headed by Fuad El-Hibri, chairman and chief executive officer and Daniel J. Abdun-Nabi, president and chief operating officer, are hosting “Bioterrorism Prevention, Preparedness and Response,” a forum uniquely organized for members of the North Atlantic Treaty Organization (NATO) Parliamentary Assembly (PA). The one-day event is an interactive discussion related to biopreparedness strategies and best practices such as funding, development, and manufacture of biodefense medical countermeasures, creation of strategic stockpiles, and cooperation within the international community.

“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.

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

by Nick Rees on December 8, 2009

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

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

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

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

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

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

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

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

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

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

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

Digg Fuad El-Hibri Wikipedia Article

Fuad El-Hibri Chairman of the Board of Directors and Chief Executive Officer Emergent BioSolutions Inc.