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	<title>Fuad El-Hibri Organization Blog &#187; Federal government of the United States</title>
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		<title>Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments</title>
		<link>http://fuad-elhibri.org/2010/07/07/emergent-biosolutions-completes-deliveries-of-biothrax-to-allied-foreign-governments/</link>
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		<pubDate>Wed, 07 Jul 2010 10:24:24 +0000</pubDate>
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				<category><![CDATA[Anthrax]]></category>
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		<description><![CDATA[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 [...]


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			<content:encoded><![CDATA[<p><strong>ROCKVILLE, MD,  June 24, 2010</strong> – Emergent  BioSolutions  Inc. (NYSE:EBS) led by CEO <a onclick="javascript:pageTracker._trackPageview('/outbound/article/www.usatoday.com');" href="http://www.usatoday.com/money/2004-05-18-muslim-ceos_x.htm">Fuad  El-Hibri</a><span style="font-family: verdana,sans-serif;"><span style="font-family: arial;">,</span></span>announced today that it has  completed separate international sales and deliveries of  BioThrax<sup>®</sup> (Anthrax Vaccine Adsorbed) to governments of several allied nations.    The company’s international sales efforts have resulted<strong> </strong>in  these sales of an undisclosed  number of BioThrax doses for aggregate  revenue of approximately $2.3 million in  the second quarter.</p>
<p>“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.”</p>
<p><strong>About BioThrax</strong></p>
<p>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  <em>Bacillus anthracis.</em> 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 <a onclick="javascript:pageTracker._trackPageview('/outbound/article/www.biothrax.com');" href="http://www.biothrax.com/prescribinginformation_biothrax_us.pdf" target="_blank">www.biothrax.com/prescribinginformation_biothrax_us.pdf</a>.</p>
<p><strong>Important Safety Information  for BioThrax<sup>®</sup></strong></p>
<p>The most  common (&gt;10%) local (injection-site) adverse reactions  observed in clinical  studies were tenderness, pain, erythema and arm  motion limitation. The most  common (&gt;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.</p>
<p>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.</p>
<p>Vaccination with BioThrax should  be avoided by individuals with a  history of anaphylactic or  anaphylactic-like reaction following a  previous dose of BioThrax.</p>
<p><strong>About Emergent BioSolutions  Inc.</strong></p>
<p>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<sup>®</sup> (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 <a title="http://www.emergentbiosolutions.com/" onclick="javascript:pageTracker._trackPageview('/outbound/article/www.emergentbiosolutions.com');" href="http://www.emergentbiosolutions.com/" target="_blank">www.emergentbiosolutions.com</a>.</p>
<p><strong> </strong></p>
<p><strong>Safe</strong><strong> Harbor</strong><strong> Statement</strong></p>
<p>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<sup>®</sup> procurement; our ability to  obtain new BioThrax<sup>®</sup> sales contracts; our plans to pursue  label expansions and improvements for  BioThrax<sup>®</sup>; 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.</p>
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		<title>Fuad el-Hibri, king of anthrax, wins an award from Ernst &amp; Young</title>
		<link>http://fuad-elhibri.org/2009/12/17/fuad-el-hibri-king-of-anthrax-wins-an-award-from-ernst-young/</link>
		<comments>http://fuad-elhibri.org/2009/12/17/fuad-el-hibri-king-of-anthrax-wins-an-award-from-ernst-young/#comments</comments>
		<pubDate>Thu, 17 Dec 2009 12:08:57 +0000</pubDate>
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				<category><![CDATA[Biothrax]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=189</guid>
		<description><![CDATA[
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&#38;Y 2009 prize, which [...]


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			<content:encoded><![CDATA[<div>
<p>Marie-José Daoud</p>
<p>Awarded the Ernst and Young prize for Entrepreneur of the year 2009 in the Technology category for the Greater Washington region last June, <a href="http://fuadelhibri.livejournal.com/">Fuad El-Hibri</a> 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&amp;Y 2009 prize, which will be awarded on November 14 in California<br />
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 &amp; 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).</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>Anthrax</p>
<p>Anthrax is an infectious disease caused by the spore-forming bacterium Bacillus anthracis.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>This is partially why the E&amp;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.<br />
—</p>
<p>www.emergentbiosolutions.com</p></div>
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		<title>Emergent BioSolutions reacts to BARDA&#8217;s Request for Proposal cancellation</title>
		<link>http://fuad-elhibri.org/2009/12/16/emergent-biosolutions-reacts-to-bardas-request-for-proposal-cancellation/</link>
		<comments>http://fuad-elhibri.org/2009/12/16/emergent-biosolutions-reacts-to-bardas-request-for-proposal-cancellation/#comments</comments>
		<pubDate>Wed, 16 Dec 2009 10:56:59 +0000</pubDate>
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		<description><![CDATA[by Nick Rees on December  8, 2009 
Fuad El-Hibri
The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA&#8217;s Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office&#8217;s Broad Agency Announcement.
BARDA canceled the RFP for the procurement for rPA vaccines after [...]


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			<content:encoded><![CDATA[<h3><small>by <a href="http://www.bioprepwatch.com/authors/nick-rees/news/all">Nick Rees</a> on December  8, 2009 </small></h3>
<div><a href="http://cms.newsinator.com/system/datas/1146/original/El-Hibri_Fuad.jpg"><img src="http://cms.newsinator.com/system/datas/1146/original/El-Hibri_Fuad.jpg" alt="El-hibri_fuad" width="150" /></a><a href="http://crackle.com/members/2591146">Fuad El-Hibri</a></div>
<p><span style="font-size: small;"><span style="font-family: arial,helvetica,sans-serif;">The Office of the Biomedical Advanced Research and Development Authority has advised Emergent BioSolutions that while BARDA&#8217;s Request for Proposal has been canceled, Emergent is encouraged to submit a proposal for the office&#8217;s Broad Agency Announcement.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>This announcement also does not impact Emergent&#8217;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.</p>
<p>“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.”</p>
<p>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.</p>
<p>“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,&#8221; Daniel J.Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, said. &#8220;BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.”</p>
<p>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&#8217;s new 50,000-square-foot Lansing, Mich., manufacturing facility.</p>
<p>&#8220;I am proud that Lansing remains home to America&#8217;s first line of defense against what experts say is the single biggest bioterror threat, anthrax,&#8221; U.S. Rep. Mike Rogers, MI-08, said. &#8220;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.</p>
<p>&#8220;Rest assured, I will continue working to strengthen our nation&#8217;s existing bioterror preparedness measures and protect national security jobs in Lansing.&#8221;</span></span></p>
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		<title>Bad News Clouds Two Bio Defense Stocks</title>
		<link>http://fuad-elhibri.org/2009/12/16/bad-news-clouds-two-bio-defense-stocks/</link>
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		<pubDate>Wed, 16 Dec 2009 10:29:58 +0000</pubDate>
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		<description><![CDATA[Written by Staff and Wire Reports
Tuesday, 08 December 2009 01:28
Key news developments will affect shares of these two companies who help meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.
The two companies which waited until late after hours on Monday to announce [...]


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			<content:encoded><![CDATA[<p>Written by Staff and Wire Reports<br />
Tuesday, 08 December 2009 01:28</p>
<p>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.</p>
<p>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.</p>
<p>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).</p>
<p>PharmAthene was informed of BARDA&#8217;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.</p>
<p>In similar news&#8230;</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>After selling dies down, there may be a bounce trade opportunity for EBS followers since the company feels that &#8220;BioThrax remains a critical and long-term countermeasure for the US government,” said <a href="http://www.tagged.com/fuadelhibri">Fuad El-Hibri</a>, 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.”</p>
<p>Source :: http://biomedreports.com/articles/most-popular/20870-bad-news-clouds-move-in-on-these-stocks.html</p>
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		<title>EMERGENT BIOSOLUTIONS SIGNS $448 MILLION THREE YEAR CONTRACT WITH DEPARTMENT OF HEALTH AND HUMAN SERVICES</title>
		<link>http://fuad-elhibri.org/2009/07/14/emergent-biosolutions-signs-448-million-three-year-contract-with-department-of-health-and-human-services/</link>
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		<pubDate>Tue, 14 Jul 2009 15:42:55 +0000</pubDate>
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		<description><![CDATA[ROCKVILLE, MD, September 26, 2007—Emergent BioSolutions Inc. (NYSE: EBS), announced today that it has signed a three year contract with the U.S. Department of Health and Human Services (HHS), with a total value of up to $448 million.  Components of the contract include:
(i)           $400 million firm fixed-price for delivery of 18.75 million doses of BioThrax® [...]


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			<content:encoded><![CDATA[<p><strong>ROCKVILLE, MD, September 26, 2007</strong>—Emergent BioSolutions Inc. (NYSE: <a class="zem_slink" title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">EBS</a>), announced today that it has signed a three year contract with the <a class="zem_slink" title="United States Department of Health and Human Services" rel="homepage" href="http://www.hhs.gov/">U.S. Department of Health and Human Services</a> (HHS), with a total value of up to $448 million.  Components of the contract include:</p>
<p>(i)           $400 million firm fixed-price for delivery of 18.75 million doses of BioThrax<sup>®</sup> (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (<a class="zem_slink" title="Strategic National Stockpile" rel="wikipedia" href="http://en.wikipedia.org/wiki/Strategic_National_Stockpile">SNS</a>);</p>
<p>(ii)          $34 million for receipt of regulatory approval of 4-year expiry dating for BioThrax payable through a combination of a lump-sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the per dose price to be paid for doses delivered following approval;</p>
<p>(iii)         up to $11.5 million in milestone payments in connection with advancement towards a <a class="zem_slink" title="Post-exposure prophylaxis" rel="wikipedia" href="http://en.wikipedia.org/wiki/Post-exposure_prophylaxis">post-exposure prophylaxis</a> (PEP) indication for BioThrax; and,</p>
<p>(iv)         $2.2 million for logistics services and other related support.</p>
<p>The Company anticipates making deliveries for approximately 6 million doses under this contract by year-end 2007.  As a result, the company reaffirms its expectation for full year total revenue growth of 10 to 15 percent, with a bias toward the upper end of the range, and full year positive net earnings.</p>
<p><a href="http://www.nationalhealthmuseum.org/themuseum/board.html">Fuad El-Hibri,</a> chairman and chief executive officer of Emergent BioSolutions, stated, “We are honored to continue our longstanding relationship with HHS to provide BioThrax as a critical component of our nation’s biodefense stockpile.  I applaud the dedication and professionalism of the senior leadership within HHS and <a class="zem_slink" title="Biomedical Advanced Research and Development Authority" rel="wikipedia" href="http://en.wikipedia.org/wiki/Biomedical_Advanced_Research_and_Development_Authority">Biomedical Advanced Research and Development Authority</a> in completing this important step towards enhancing our domestic biodefense infrastructure.  Emergent BioSolutions remains dedicated to working with various <a class="zem_slink" title="Federal government of the United States" rel="wikipedia" href="http://en.wikipedia.org/wiki/Federal_government_of_the_United_States">government</a> agencies in their commitment to procure medical countermeasures as a primary element of establishing the highest possible levels of biopreparedness.”</p>
<p>Under terms of the contract, HHS will purchase from the company an aggregate of 18.75 million doses of BioThrax through September 2010, for a firm, fixed-price of $400 million.  In the event the company receives <a class="zem_slink" title="U.S. Food and Drug Administration" rel="homepage" href="http://www.fda.gov/">U.S. Food and Drug Administration</a> (FDA) approval of the company’s pending supplement to its biologics license application (BLA) to extend the shelf life of BioThrax from three years to four years, the company will receive a lump sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the price per dose to be paid for doses delivered following the date of approval, with a total value of approximately $34 million.  If FDA approval of 4-year expiry dating is not received during the term of the contract, the company will not be entitled to receive any of the $34 million.  The company submitted its supplement for 4-year expiry dating to the FDA in December 2006 and has been providing additional information to the agency in support of its application.</p>
<p>Under the contract, HHS will also provide up to $11.5 million in connection with advancing the company’s program to obtain a PEP indication for BioThrax.  The PEP indication, which would expand the use of BioThrax beyond the current pre-exposure prophylaxis indication, is designed to permit the administration of BioThrax in combination with antibiotics following exposure to anthrax.  These funds are payable upon the company’s achievement of specific program milestones.  The company anticipates that it will receive $8.8 million of this amount in the fourth quarter of 2007.</p>
<p>In addition, under the contract the company has agreed to provide all shipping services related to delivery of doses into the SNS over the contract term, and will receive payment of an additional $2.2 million.</p>
<p>The contract has been funded with Federal funding through the <a class="zem_slink" title="Project Bioshield Act" rel="wikipedia" href="http://en.wikipedia.org/wiki/Project_Bioshield_Act">Project BioShield</a> Special Reserve Fund, which was created by an act of Congress in May 2004.</p>
<p>Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to HHS for inclusion in the SNS under a May 2005 supply agreement for 5 million doses valued at $123 million and a May 2006 contract modification for an additional 5 million doses valued at $120 million.</p>
<p><strong>Conference Call &amp; Webcast</strong></p>
<p>Company management will host a conference call at 9:00 am Eastern today, September 26, 2007 to discuss this announcement.  Interested parties may participate in the live teleconference by dialing 866/383-8008 or 617/597-5341 or via a webcast accessible at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>, under “Investors”.  A replay of the teleconference will be available on the company website or by dialing 888/286-8010 or 617/801-6888 and using the passcode 61817264, approximately one hour after the teleconference concludes.  The replay will be available through October 10, 2007.</p>
<p><strong>About BioThrax® (Anthrax Vaccine Adsorbed)</strong></p>
<p>BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection.  It is approved by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores.  BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of <em>Baccillus anthracis</em> and contains no dead or live bacteria.  BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter.  Since 1998, approximately 20 million doses of BioThrax have been procured by the <a class="zem_slink" title="United States" rel="geolocation" href="http://maps.google.com/maps?ll=38.8833333333,-77.0166666667&amp;spn=10.0,10.0&amp;q=38.8833333333,-77.0166666667%20%28United%20States%29&amp;t=h">U.S.</a> government.  During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel.  BioThrax cannot cause anthrax infection.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—<strong>to protect life</strong>.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Our commercial business focuses on immunobiotics for use against <a class="zem_slink" title="Infectious disease" rel="wikipedia" href="http://en.wikipedia.org/wiki/Infectious_disease">infectious diseases</a> and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>.</p>
<p><strong>Safe</strong><strong> Harbor</strong><strong> Statement</strong></p>
<p>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 our performance under our contract with HHS and future payments from HHS to us under the contract, and any other statements containing the words &#8220;believes&#8221;, &#8220;expects&#8221;, &#8220;anticipates&#8221;, &#8220;plans&#8221;, &#8220;estimates&#8221; and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company&#8217;s actual results to differ materially from those indicated by such forward-looking statements, including our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company&#8217;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.</p>
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		<title>EMERGENT BIOSOLUTIONS RECEIVES DEVELOPMENT CONTRACT FROM NIAID/BARDA TO FUND CONTINUED DEVELOPMENT OF ANTHRAX THERAPEUTIC</title>
		<link>http://fuad-elhibri.org/2009/07/14/emergent-biosolutions-receives-development-contract-from-niaidbarda-to-fund-continued-development-of-anthrax-therapeutic/</link>
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		<pubDate>Tue, 14 Jul 2009 15:32:43 +0000</pubDate>
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		<description><![CDATA[

ROCKVILLE, MD., September 27, 2007—Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has received a development contract, valued at up to $9.5 million, in support of non-clinical and clinical studies of the company’s anthrax therapeutic, or AIG, product candidate.  This product candidate is an immune globulin being developed as an intravenous therapeutic for treatment [...]


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<p><strong>ROCKVILLE, MD., September 27, 2007</strong>—Emergent BioSolutions Inc. (NYSE: <a class="zem_slink" title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">EBS</a>) announced today that it has received a development contract, valued at up to $9.5 million, in support of non-clinical and clinical studies of the company’s anthrax therapeutic, or <a class="zem_slink" title="NYSE: AIG" rel="stockexchange" href="http://finance.yahoo.com/q?s=AIG">AIG</a>, product candidate.  This product candidate is an immune globulin being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease following exposure to anthrax.</p>
<p>This development contract has been funded in whole or in part from Federal funds from the <a class="zem_slink" title="National Institute of Allergy and Infectious Diseases" rel="wikipedia" href="http://en.wikipedia.org/wiki/National_Institute_of_Allergy_and_Infectious_Diseases">National Institute of Allergy and Infectious Diseases</a> (NIAID), <a class="zem_slink" title="National Institutes of Health" rel="geolocation" href="http://maps.google.com/maps?ll=39.000443,-77.102394&amp;spn=1.0,1.0&amp;q=39.000443,-77.102394%20%28National%20Institutes%20of%20Health%29&amp;t=h">National Institutes of Health</a> (NIH) and the <a class="zem_slink" title="Biomedical Advanced Research and Development Authority" rel="wikipedia" href="http://en.wikipedia.org/wiki/Biomedical_Advanced_Research_and_Development_Authority">Biomedical Advanced Research and Development Authority</a> (BARDA), <a class="zem_slink" title="United States Department of Health and Human Services" rel="homepage" href="http://www.hhs.gov/">Department of Health and Human Services</a> (HHS), under Contract No. HHSN272200700034C.</p>
<p><a href="http://fundrace.huffingtonpost.com/neighbors.php?type=name&amp;lname=EL-HIBRI&amp;fname=FUAD">Fuad El-Hibri</a>, chairman and chief executive officer of Emergent BioSolutions, stated, “We are very pleased to have continuing support for AIG from NIAID and BARDA and commend the leadership throughout HHS for their commitment to funding the development of effective medical countermeasures against this deadly biological agent.  With the continued development funding of our AIG candidate, in conjunction with the $448 million contract with HHS announced yesterday regarding procurement of 18.75 million doses of our BioThrax anthrax vaccine for the strategic national stockpile, we are very encouraged by the government’s support of our anthrax franchise.  We look forward to continuing to be a leading participant in the <a class="zem_slink" title="Federal government of the United States" rel="wikipedia" href="http://en.wikipedia.org/wiki/Federal_government_of_the_United_States">U.S. government</a>’s effort to build a robust domestic biodefense industry.”</p>
<p>Under terms of the development award, the funds will be used to conduct various studies on AIG, including (i) non-clinical studies in support of efficacy; and (ii) a Phase I/II clinical study to evaluate pharmacokinetics and safety.  Previously, in August 2006 the company received $3.9 million from NIAID in support of the company’s AIG program.  When combined with the $9.5 million under this new development award, the total amount of government funding for AIG to date is over $13 million.</p>
<p><strong>About Anthrax Immune Globulin (AIG)</strong></p>
<p>Emergent BioSolutions’ anthrax immune globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body and for whom the use of the vaccine is no longer an effective option.  If successfully developed, AIG could be prescribed for administration in these circumstances either as a monotherapy or in conjunction with an antibiotic.</p>
<p>AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), Emergent BioSolutions’ anthrax vaccine, which is the only vaccine approved by the <a class="zem_slink" title="U.S. Food and Drug Administration" rel="homepage" href="http://www.fda.gov/">U.S. Food and Drug Administration</a> for the prevention of anthrax infection.</p>
<p>The company has collected a sufficient amount of plasma to initiate manufacturing of AIG under cGMP using a validated and approved process.  This manufacturing process entails fractionating the plasma and purifying the immune globulin.  The company has signed an exclusive license with Talecris Biotherapeutics, Inc., a North Carolina-based biopharmaceutical company and leading fractionation provider, to fractionate, purify and fill AIG at Talecris’ FDA-approved facilities.  To date, the first full-scale lot of AIG has been manufactured under cGMP requirements at Talecris.  The company has scheduled plans to complete a second full-scale lot of AIG.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—<strong>to protect life</strong>.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.  Our commercial business focuses on immunobiotics for use against <a class="zem_slink" title="Infectious disease" rel="wikipedia" href="http://en.wikipedia.org/wiki/Infectious_disease">infectious diseases</a> and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>.</p>
<p><strong>Safe</strong><strong> Harbor</strong><strong> Statement</strong></p>
<p>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 our performance under our contract with HHS and future payments from HHS to us under the contract, and any other statements containing the words &#8220;believes&#8221;, &#8220;expects&#8221;, &#8220;anticipates&#8221;, &#8220;plans&#8221;, &#8220;estimates&#8221; and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company&#8217;s actual results to differ materially from those indicated by such forward-looking statements, including our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and <a class="zem_slink" title="Clinical trials" rel="wikinvest" href="http://www.wikinvest.com/concept/Clinical_trials">clinical trials</a>; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company&#8217;s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.</p>
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		<title>EMERGENT BIOSOLUTIONS ANNOUNCES EXPANSION OF BOARD OF DIRECTORS AND APPOINTMENT OF DR. SUE BAILEY TO THE COMPANY’S BOARD OF DIRECTORS</title>
		<link>http://fuad-elhibri.org/2009/07/14/emergent-biosolutions-announces-expansion-of-board-of-directors-and-appointment-of-dr-sue-bailey-to-the-company%e2%80%99s-board-of-directors/</link>
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		<pubDate>Tue, 14 Jul 2009 15:21:54 +0000</pubDate>
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		<description><![CDATA[ROCKVILLE, MD, June 15, 2007—Emergent BioSolutions Inc. (NYSE: EBS), a biopharmaceutical company, announced today that at a regularly scheduled meeting of its board of directors the board passed a resolution authorizing the expansion of the total number of members of the board to eight.  The board also unanimously appointed Sue Bailey, M.D., as a Class [...]


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			<content:encoded><![CDATA[<p><strong>ROCKVILLE, MD, June 15, 2007</strong>—Emergent BioSolutions Inc. (NYSE: <a class="zem_slink" title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">EBS</a>), a biopharmaceutical company, announced today that at a regularly scheduled meeting of its board of directors the board passed a resolution authorizing the expansion of the total number of members of the board to eight.  The board also unanimously appointed Sue Bailey, M.D., as a Class III director, for a two-year term that will expire at the 2009 annual meeting of stockholders.</p>
<p>“I am delighted to welcome Dr. Bailey to the Emergent BioSolutions <a class="zem_slink" title="Board of directors" rel="wikipedia" href="http://en.wikipedia.org/wiki/Board_of_directors">Board of Directors</a>.  Her extensive experience in managing complex organizations and healthcare-related issues for both the federal <a class="zem_slink" title="Federal government of the United States" rel="wikipedia" href="http://en.wikipedia.org/wiki/Federal_government_of_the_United_States">government</a> and private corporations and her expertise in media relations will contribute greatly to our ability to meet our nation’s need for bioterrorism countermeasures and to create shareholder value,” said <a href="http://www.hpa.org.uk/webw/HPAweb&amp;HPAwebStandard/HPAweb_C/1195733729612?p=1158945066102">Fuad El-Hibri</a>, Emergent BioSolutions’ chairman and chief executive officer.</p>
<p>Dr. Bailey served as a news analyst for <a class="zem_slink" title="NBC Universal" rel="homepage" href="http://www.nbcuni.com">NBC</a> Universal from 2001 to 2006, focused on national security, bioterrorism, environmental safety and public health issues.  Dr. Bailey also served as Administrator for the National Highway Traffic Safety Administration from 2000 to 2001, as Assistant Secretary Of Defense (Health Affairs) from 1998 to 2000, and as <a class="zem_slink" title="United States Secretary of Defense" rel="wikipedia" href="http://en.wikipedia.org/wiki/United_States_Secretary_of_Defense">Deputy Assistant Secretary Of Defense</a> (Clinical Services) from 1994 to 1995.  During her tenure with DoD Health Affairs, Dr. Bailey headed the $17 billion military <a class="zem_slink" title="Medicine" rel="wikipedia" href="http://en.wikipedia.org/wiki/Medicine">medical</a> system, with responsibility for protecting American <a class="zem_slink" title="United States armed forces" rel="wikipedia" href="http://en.wikipedia.org/wiki/United_States_armed_forces">military forces</a> from combat causalities, disease, environmental hazards, and biochemical warfare.</p>
<p>“Protecting America’s military men and women against acts of bioterrorism and safeguarding citizens against infectious diseases has been the focus of my career,” said Dr. Bailey.  “I am pleased to be joining the Board of Emergent BioSolutions where I can help guide the company’s development of medical countermeasures that can protect the lives of those most at risk.”</p>
<p>Dr. Bailey is a board certified physician whose clinical and academic background included a faculty position at Georgetown University Medical  School.  In addition, she was formerly a Navy officer, having achieved the rank of Lt. Commander, <a class="zem_slink" title="United States" rel="geolocation" href="http://maps.google.com/maps?ll=38.8833333333,-77.0166666667&amp;spn=10.0,10.0&amp;q=38.8833333333,-77.0166666667%20%28United%20States%29&amp;t=h">U.S.</a> Navy Reserve.  Dr. Bailey also serves as an advisor or member of the board of directors for a variety of industry, academic and trade healthcare and safety-oriented organizations.</p>
<p>Dr. Bailey holds a degree from the University of  Maryland and her medical degree from the Philadelphia College of Osteopathic Medicine.  She completed her internship and residency at George Washington University and completed a medical post-graduate fellowship at <a class="zem_slink" title="Johns Hopkins University" rel="geolocation" href="http://maps.google.com/maps?ll=39.330049,-76.620669&amp;spn=1.0,1.0&amp;q=39.330049,-76.620669%20%28Johns%20Hopkins%20University%29&amp;t=h">Johns  Hopkins University</a>.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission—<strong>to protect life</strong>.  We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare.  Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. <a class="zem_slink" title="U.S. Food and Drug Administration" rel="homepage" href="http://www.fda.gov/">Food and Drug Administration</a> for the prevention of anthrax infection.  Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs.  More information on the company is available at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>.</p>
<p><strong>Safe</strong><strong> Harbor</strong><strong> Statement</strong></p>
<p>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 our expected revenue growth and net earnings for 2007, 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 our performance under BioThrax® sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; 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 product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Annual Report on Form 10-K for the year ended December 31, 2006 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.</p>
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