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	<title>Fuad El-Hibri Organization Blog &#187; National Institutes of Health</title>
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		<title>Emergent BioSolutions Starts Phase I Clinical Trial for Third Generation Anthrax Vaccine</title>
		<link>http://fuad-elhibri.org/2011/01/05/emergent-biosolutions-starts-phase-i-clinical-trial-for-third-generation-anthrax-vaccine/</link>
		<comments>http://fuad-elhibri.org/2011/01/05/emergent-biosolutions-starts-phase-i-clinical-trial-for-third-generation-anthrax-vaccine/#comments</comments>
		<pubDate>Wed, 05 Jan 2011 04:59:31 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Anthrax vaccines]]></category>
		<category><![CDATA[Biothrax]]></category>
		<category><![CDATA[Chief executive officer]]></category>
		<category><![CDATA[El-Hibri]]></category>
		<category><![CDATA[Emergent BioSolutions]]></category>
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		<category><![CDATA[Clinical trial]]></category>
		<category><![CDATA[National Institute of Allergy and Infectious Diseases]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=279</guid>
		<description><![CDATA[ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions  Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical  trial for NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909  Adjuvant), also known as AV7909, with the dosing of the first subject.  The product candidate, a third generation vaccine being developed [...]


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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., Dec 27, 2010 (BUSINESS WIRE) — Emergent BioSolutions  Inc. (NYSE:EBS) today announced the initiation of a Phase I clinical  trial for NuThrax<sup>TM</sup> (Anthrax Vaccine Adsorbed with CPG 7909  Adjuvant), also known as AV7909, with the dosing of the first subject.  The product candidate, a third generation vaccine being developed as  part of Emergent’s anthrax franchise, consists of BioThrax<sup>(R)</sup> (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909.</p>
<p>“Emergent is pleased to commence this clinical trial in support of  the U.S. government’s multiple product strategy to strengthen the  nation’s biodefense capabilities,” said Daniel J. Abdun-Nabi, president  and chief operating officer of Emergent BioSolutions. “We believe this  third generation anthrax vaccine has the potential to exhibit advanced  characteristics such as requiring fewer doses, generating an enhanced  immune response, and having a favorable shelf life. If successful, this  could be an attractive candidate for the government’s growing arsenal of  medical countermeasures.”</p>
<p>The Phase I clinical trial, a parallel arm dose-ranging study, is  designed to evaluate the safety, tolerability, and immunogenicity of the  vaccine candidate. The study is being conducted in multiple sites  within the U.S. and involves 105 healthy volunteers. Preliminary data  from this study is expected to be available in the third quarter of  2011.</p>
<p>This Phase I trial is being conducted with support from a development  contract that is jointly administered under contract number  HHSN272200800051C by the <a href="http://www.niaid.nih.gov/Pages/default.aspx">National Institute of Allergy and Infectious Diseases</a> (NIAID), a component of the <a href="http://www.nih.gov/">National Institutes of Health</a> (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the <a href="http://www.hhs.gov/">Department of Health and Human Services</a> (HHS).</p>
<p>About Emergent BioSolutions Inc.</p>
<p>Emergent BioSolutions Inc., led by Chairman and CEO <a href="http://www.webbiographies.com/JournalViewVisitor.do?method=view&amp;chapterid=471793&amp;visitingbioid=31678">Fuad El-Hibri,</a> is a global 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 and investigational products target infectious  diseases, oncology, and autoimmune disorders. Additional information  about the company may be found at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>.</p>
<p>Safe Harbor Statement</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 the  success of our ongoing and planned preclinical studies and clinical  trials; our plans to pursue label expansions and improvements for  BioThrax<sup>(R)</sup>; 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 September 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>
<p>SOURCE: Emergent BioSolutions Inc.</p>


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		<title>Fuad El-Hibri and the International Biomedical Research Alliance</title>
		<link>http://fuad-elhibri.org/2010/11/13/fuad-el-hibri-and-the-international-biomedical-research-alliance/</link>
		<comments>http://fuad-elhibri.org/2010/11/13/fuad-el-hibri-and-the-international-biomedical-research-alliance/#comments</comments>
		<pubDate>Sat, 13 Nov 2010 10:50:38 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Anthrax]]></category>
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		<category><![CDATA[Emergent BioSolutions]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=270</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://fuad-elhibri.org/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>
		<comments>http://fuad-elhibri.org/2010/09/10/emergent-biosolutions-awarded-niaid-contract-that-increases-potential-funding-to-over-58-million-for-advanced-development-of-third-generation-anthrax-vaccine/#comments</comments>
		<pubDate>Fri, 10 Sep 2010 11:39:37 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=257</guid>
		<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 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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		<category><![CDATA[Biomedical Advanced Research and Development Authority]]></category>
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		<category><![CDATA[Infectious disease]]></category>
		<category><![CDATA[National Institute of Allergy and Infectious Diseases]]></category>
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		<category><![CDATA[U.S. Food and Drug Administration]]></category>
		<category><![CDATA[United States Department of Health and Human Services]]></category>

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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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