Emergent BioSolutions reacts to BARDA’s Request for Proposal cancellation

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.”

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

Marie-José Daoud

Awarded the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region last June, Fuad El-Hibri is the CEO of Emergent Biosolutions, an American company that supplies the anthrax vaccine to the American government. He is in line for the national E&Y 2009 prize, which will be awarded on November 14 in California
He is a tall, imposing and smiling man. He has the assurance of those who are proud of their career and the modesty of those who attribute their success to the staff around them. He has just won the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region. This prize rewards over 15 years in the biopharmaceutical industry, ten of which have been dedicated to Emergent Biosolutions, the company that supplies the only anthrax vaccine approved by the American government’s powerful Food and Drug Administration (FDA). Fuad El-Hibri landed in biopharmaceuticals somewhat by chance and somewhat by interest. He defines himself as “an entrepreneur in spirit” and, before dedicating himself to biopharmaceuticals, he had already created and sold various telecommunications companies in Russia, Venezuela and El Salvador. In the early 90s, this German native, born to a Lebanese father and a German mother, and who had spent time in the banking industry (Citibank) and consultant (BoozAllen & Hamilton), joins Porton Product, a biotechnology company located in the United Kingdom. There he plays a predominant role in marketing and sales of biodefense vaccines to foreign governments. Hibri is, in particular, a key man behind the purchase by Saudi Arabia of anthrax vaccines during the first Gulf war. This is where he maintains he gained his insight into the magnitude of the need for medical solutions to combat bioterrorism. In 1994, he organized the buy-back of Porton Products by its managers, before reselling his shares in 1996 (the price is not known).

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

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

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

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

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

Anthrax

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

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

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

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

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

500 Most Influential Muslims: Science and Technology

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

Nominations Being Accepted Now for 2010 El-Hibri Peace Education Prize

The El-Hibri Peace Education Prize is awarded yearly to an individual who is making valuable contributions to peace education and social justice in the Middle East. The purpose of the $10,000 prize is to recognize outstanding peace educators, to provide financial support to continue peace education and study, and to promote the importance of peace education globally by affirming efforts to integrate peacemaking into curricula at all levels of education.

The prize was founded in 2007 by businessman and philanthropist Fuad El-Hibri and his wife Nancy El-Hibri in order to highlight the importance of peace education and to support people who are working for a just, peaceful and healthy planet. El-Hibri is the CEO of Emergent BioSolutions, as well Chairman of the El-Hibri Charitable Foundation. Past winners include Professor Abdul Aziz Said, the Mohammed Said Farsi Chair of Islamic Peace at American University; Scott Kennedy, an influential Peace Educator for 40 years; and Dr. Mary Elizabeth King a professor of peace and conflict studies at the United Nations-affiliated University for Peace.

Nominations for the 2010 prize will be accepted until June 6, 2010, with the winner announced on July 11, 2010. The award will be presented on September 21, 2010, which is the International Day of Peace. Nominees can be individuals or organizations based in the United States making valuable contributions to the theory, practice, and teaching of peace and social justice in the Middle East. More information about the nomination process and the prize itself can be found at http://www.elhibriprize.org .

Nominations, questions, and financial contributions may be sent to: nonviolence@igc.org

Emergent BioSolutions Chairman and CEO Fuad El-Hibri Recognized as Outstanding International Business Leader

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

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.