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	<title>Fuad El-Hibri Wire &#187; Vaccine</title>
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	<description>News Updates on Fuad El-Hibri</description>
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		<title>Fuad El-Hibri and the International Biomedical Research Alliance</title>
		<link>http://fuadelhibri.cc/2010/11/13/fuad-el-hibri-and-the-international-biomedical-research-alliance/</link>
		<comments>http://fuadelhibri.cc/2010/11/13/fuad-el-hibri-and-the-international-biomedical-research-alliance/#comments</comments>
		<pubDate>Sat, 13 Nov 2010 11:12:44 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Anthrax Vaccine]]></category>
		<category><![CDATA[BioThrax]]></category>
		<category><![CDATA[Chief executive officer]]></category>
		<category><![CDATA[Emergent BioSolutions]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[Fuad El-Hibri]]></category>
		<category><![CDATA[Vaccine]]></category>
		<category><![CDATA[Anthrax vaccines]]></category>
		<category><![CDATA[Infectious disease]]></category>
		<category><![CDATA[Leadership]]></category>
		<category><![CDATA[Medical research]]></category>

		<guid isPermaLink="false">http://fuadelhibri.cc/?p=394</guid>
		<description><![CDATA[The International Biomedical Research Alliance (IBRA) is a philanthropic organization that is dedicated to the support  of the NIH-Oxford-Cambridge Scholars Program, which strives to  establish the highest standards of excellence in training biomedical  researchers, advance groundbreaking biomedical research, enrich the pool  of leaders in the field, and eliminate barriers which frustrate [...]


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			<content:encoded><![CDATA[<p>The <a href="http://www.biomedalliance.org/">International Biomedical Research Alliance</a> (IBRA) is a philanthropic organization that is dedicated to the support  of the NIH-Oxford-Cambridge Scholars Program, which strives to  establish the highest standards of excellence in training biomedical  researchers, advance groundbreaking biomedical research, enrich the pool  of leaders in the field, and eliminate barriers which frustrate the  transfer of a broad spectrum of knowledge to the next generation of  researchers.</p>
<p>Along with colleagues from industry, education, and government, <a href="http://www.elhibrifoundation.org/board.html">Fuad El-Hibri</a> is a member of the IBRA Board of Directors. The Alliance helps provide  opportunities for students to build and develop important elements of  scientific leadership, giving students the opportunity to grow into  exceptional biomedical research leaders. IBRA firmly believes in the  ability of outstanding researchers to transform today’s promise of cures  and treatments into available therapies, drugs and prevention measures  that enhance the world’s health.</p>
<p>Since its inception in 2000, the Scholars program has recruited  gifted, inquiring, creative and dedicated minds for a uniquely designed  doctoral program of training and investigative, exploration to  challenges some of the worlds greatest minds to achieve IBRA’s main goal  to create the premier PhD and MD/PhD program.</p>
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		<title>Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine</title>
		<link>http://fuadelhibri.cc/2010/09/10/emergent-biosolutions-awarded-niaid-contract-that-increases-potential-funding-to-over-58-million-for-advanced-development-of-third-generation-anthrax-vaccine/</link>
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		<pubDate>Fri, 10 Sep 2010 13:06:24 +0000</pubDate>
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				<category><![CDATA[Anthrax Vaccine]]></category>
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		<description><![CDATA[New Contract Valued at up to $28.7 Million for Phase II Clinical Trial
ROCKVILLE, Md., Sep 01, 2010 –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has  signed a contract valued at up to $28.7 million with the National  Institute of Allergy and Infectious Diseases (NIAID), an institute  within the National Institutes of [...]


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			<content:encoded><![CDATA[<p style="text-align: center;"><strong>New Contract Valued at up to $28.7 Million for Phase II Clinical Trial</strong></p>
<p style="text-align: left;"><strong>ROCKVILLE, Md., Sep 01, 2010</strong> –Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has  signed a contract valued at up to $28.7 million with the National  Institute of Allergy and Infectious Diseases (NIAID), an institute  within the National Institutes of Health (NIH), for advanced development  of the company’s third generation anthrax vaccine candidate. The award  of this contract increases to over $58 million the total potential  development funding from NIAID for this product. This product candidate,  one of two third generation vaccines being developed as part of  Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine  Adsorbed) in combination with a novel immunostimulatory compound, CPG  7909 (VaxImmuneTM).</p>
<p>“Emergent applauds the U.S. government’s commitment to protecting the  nation against biological threats by supporting critical development of  advanced vaccine and therapeutic candidates,” said Daniel J.  Abdun-Nabi, president and chief operating officer of Emergent  BioSolutions. “We believe our vaccine candidate addresses key criteria  established by the government for a third generation anthrax vaccine. If  successfully developed, we believe this product would strengthen the  government’s portfolio of biodefense medical countermeasures.”</p>
<p>This four-year development contract consists of a two-year base,  valued at $9.1 million, and milestone-based options that if exercised,  would increase the total contract value to up to $28.7 million. The base  contract will fund activities related to manufacturing and stability  studies of Phase II clinical trial lots, process characterization and  assay validation, and clinical trial preparation. The milestone-based  options include continued stability testing of Phase II clinical trial  lots and a clinical study to evaluate safety and immunogenicity of the  product candidate. The Phase II clinical trial is anticipated to begin  in the first quarter of 2012, with preliminary data expected to be  available in the second half of 2012.</p>
<p>This new contract was awarded to expand the development efforts being  conducted under a Biomedical Advanced Research and Development  Authority (BARDA)/NIAID contract awarded in September 2008, which  provides for funding of up to $29.7 million. Thus, with this new  contract, the potential funding from the U.S. government for this third  generation anthrax vaccine candidate increases to over $58 million.</p>
<p><strong>About Emergent BioSolutions Inc.</strong><br />
Emergent BioSolutions Inc., led by Chairman and CEO <a href="http://fuadelhibri.org/">Fuad El-Hibri</a>,  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 <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.emergentbiosolutions.com%2F&amp;esheet=6414538&amp;lan=en-US&amp;anchor=www.emergentbiosolutions.com&amp;index=1&amp;md5=63fb7afefd4626e4cab7d3b78aa66196">www.emergentbiosolutions.com</a> .</p>
<p><strong>Safe Harbor Statement</strong><br />
This press release includes forward-looking statements within the  meaning of the Private Securities Litigation Reform Act of 1995. Any  statements, other than statements of historical fact, including  statements regarding our strategy, future operations, future financial  position, future revenues, projected costs, prospects, plans and  objectives of management, including any potential future securities  offering, our expected revenue growth and net earnings for 2010, and any  other statements containing the words “believes”, “expects”,  “anticipates”, “plans”, “estimates” and similar expressions, are  forward-looking statements. There are a number of important factors that  could cause the company’s actual results to differ materially from  those indicated by such forward-looking statements, including the  success of our ongoing and planned preclinical studies and clinical  trials; our plans to pursue label expansions and improvements for  BioThrax(R); the rate and degree of market acceptance and clinical  utility of our products; the success of our ongoing and planned  development programs; the timing of and our ability to obtain and  maintain regulatory approvals for our other product candidates; our  commercialization, marketing and manufacturing capabilities and  strategy; our estimates regarding expenses, future revenue, capital  requirements and needs for additional financing; and other factors  identified in the company’s Quarterly Report on Form 10-Q for the  quarter ended June 30, 2010 and subsequent reports filed with the SEC.  The company disclaims any intention or obligation to update any  forward-looking statements as a result of developments occurring after  the date of this press release.</p>


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		<title>Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax</title>
		<link>http://fuadelhibri.cc/2010/07/15/emergent-biosolutions-awarded-hhs-contract-valued-at-up-to-107-million-to-develop-large-scale-manufacturing-for-biothrax/</link>
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		<pubDate>Thu, 15 Jul 2010 15:21:26 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<description><![CDATA[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 [...]


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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., Jul 14, 2010</p>
<p>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<sup>(R)</sup> (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s  large-scale state-of-the-art vaccine manufacturing facility in Lansing,  Michigan.</p>
<p>“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 <a onclick="javascript:pageTracker._trackPageview('/outbound/article/projects.washingtonpost.com');" href="http://projects.washingtonpost.com/post200/2007/executive/3921/">Fuad  El-Hibri</a>, 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.”</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</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>(R)</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 onclick="javascript:pageTracker._trackPageview('/outbound/article/cts.businesswire.com');" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.emergentbiosolutions.com%2F&amp;esheet=6358735&amp;lan=en-US&amp;anchor=www.emergentbiosolutions.com&amp;index=1&amp;md5=5d039309ea707584adf105b56687bf9c">www.emergentbiosolutions.com</a>.</p>
<p><strong>About BioThrax</strong></p>
<p>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 <em>Bacillus  anthracis.</em> Since 1998, the U.S. government has procured over 42  million doses of BioThrax. During that time period, more than 9.6  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/cts.businesswire.com');" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.biothrax.com%2Fprescribinginformation_biothrax_us.pdf&amp;esheet=6358735&amp;lan=en-US&amp;anchor=www.biothrax.com%2Fprescribinginformation_biothrax_us.pdf&amp;index=2&amp;md5=be47129f1b38c1e39dfb%20">www.biothrax.com/prescribinginformation_biothrax_us.pdf</a>.</p>
<p><strong>Safe Harbor 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>(R)</sup> procurement; our ability to  obtain new BioThrax<sup>(R)</sup> sales contracts; our plans to pursue  label expansions and improvements for BioThrax<sup>(R)</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; 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.</p>


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