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	<title>Fuad El-Hibri Organization Blog &#187; Biothrax</title>
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		<title>Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax</title>
		<link>http://fuad-elhibri.org/2011/07/07/singapore-health-sciences-authority-approves-emergent-biosolutions-anthrax-vaccine-biothrax/</link>
		<comments>http://fuad-elhibri.org/2011/07/07/singapore-health-sciences-authority-approves-emergent-biosolutions-anthrax-vaccine-biothrax/#comments</comments>
		<pubDate>Thu, 07 Jul 2011 13:15:27 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Biothrax]]></category>
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		<category><![CDATA[Emergent BioSolutions]]></category>
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		<category><![CDATA[Anthrax vaccines]]></category>
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		<category><![CDATA[Singapore Ministry of Health]]></category>

		<guid isPermaLink="false">http://fuad-elhibri.org/?p=314</guid>
		<description><![CDATA[ROCKVILLE, Md., &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced on June 23rdthat the Singapore Health Sciences Authority (HSA) has approved Emergent&#8217;s product license application for the marketing and sale of BioThrax(R) (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection.
&#8220;Emergent is [...]


Related posts:<ol><li><a href='http://fuad-elhibri.org/2011/06/07/emergent-biosolutions-on-track-to-complete-delivery-of-14-5m-doses-of-biothrax-to-the-us-government-ahead-of-schedule/' rel='bookmark' title='Permanent Link: Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule'>Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule</a> <small>ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/10/14/fuad-el-hibri-announces-emergent-biosolutionsaward-to-supply-biothrax-anthrax-vaccine-to-u-s-government/' rel='bookmark' title='Permanent Link: Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government'>Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government</a> <small>Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/06/10/emergent-biosolutions-investigational-anthrax-vaccine-nuthrax-granted-fast-track-designation/' rel='bookmark' title='Permanent Link: Emergent BioSolutions&#8217; Investigational Anthrax Vaccine, NuThrax,  Granted Fast Track Designation'>Emergent BioSolutions&#8217; Investigational Anthrax Vaccine, NuThrax,  Granted Fast Track Designation</a> <small>ROCKVILLE, Md., Jun 09, 2011 &#8212; Emergent BioSolutions Inc. (NYSE:EBS)...</small></li></ol>

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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., &#8212; <a href="http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&amp;p=irol-govBio&amp;ID=158307">Emergent BioSolutions Inc</a>. (NYSE:EBS) announced on June 23<sup>rd</sup>that the Singapore Health Sciences Authority (HSA) has approved Emergent&#8217;s product license application for the marketing and sale of BioThrax<sup>(R)</sup> (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the <a href="http://www.fda.gov/">U.S. Food and Drug Administration</a> (FDA) to protect against anthrax infection.</p>
<p>&#8220;Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim,&#8221; said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. &#8220;With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon.&#8221;</p>
<p>HSA is the statutory board of the <a href="http://www.moh.gov.sg/mohcorp/default.aspx">Singapore Ministry of Health</a> that administers the country&#8217;s regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions, led by Chairman and CEO <a href="http://investing.businessweek.com/research/stocks/people/person.asp?personId=5875211&amp;ticker=EBS:AV">Fuad El-Hibri</a> protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent&#8217;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/">http://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> To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit <a href="http://www.biothrax.com/prescribinginformation_biothrax_us.pdf">http://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 2011, 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 appropriations for BioThrax<sup>(R)</sup> procurement; our ability to obtain new BioThrax<sup>(R)</sup> sales contracts or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company&#8217;s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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>


<p>Related posts:<ol><li><a href='http://fuad-elhibri.org/2011/06/07/emergent-biosolutions-on-track-to-complete-delivery-of-14-5m-doses-of-biothrax-to-the-us-government-ahead-of-schedule/' rel='bookmark' title='Permanent Link: Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule'>Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule</a> <small>ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/10/14/fuad-el-hibri-announces-emergent-biosolutionsaward-to-supply-biothrax-anthrax-vaccine-to-u-s-government/' rel='bookmark' title='Permanent Link: Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government'>Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government</a> <small>Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/06/10/emergent-biosolutions-investigational-anthrax-vaccine-nuthrax-granted-fast-track-designation/' rel='bookmark' title='Permanent Link: Emergent BioSolutions&#8217; Investigational Anthrax Vaccine, NuThrax,  Granted Fast Track Designation'>Emergent BioSolutions&#8217; Investigational Anthrax Vaccine, NuThrax,  Granted Fast Track Designation</a> <small>ROCKVILLE, Md., Jun 09, 2011 &#8212; Emergent BioSolutions Inc. (NYSE:EBS)...</small></li></ol></p>
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		<title>Emergent BioSolutions&#8217; Investigational Anthrax Vaccine, NuThrax,  Granted Fast Track Designation</title>
		<link>http://fuad-elhibri.org/2011/06/10/emergent-biosolutions-investigational-anthrax-vaccine-nuthrax-granted-fast-track-designation/</link>
		<comments>http://fuad-elhibri.org/2011/06/10/emergent-biosolutions-investigational-anthrax-vaccine-nuthrax-granted-fast-track-designation/#comments</comments>
		<pubDate>Fri, 10 Jun 2011 13:26:05 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Chief executive officer]]></category>
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		<category><![CDATA[NuThrax]]></category>
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		<category><![CDATA[fuad el-hibri]]></category>
		<category><![CDATA[anthrax vaccine]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=310</guid>
		<description><![CDATA[ROCKVILLE, Md., Jun 09, 2011 &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational anthrax vaccine, NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also known as AV7909, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with [...]


Related posts:<ol><li><a href='http://fuad-elhibri.org/2011/06/07/emergent-biosolutions-on-track-to-complete-delivery-of-14-5m-doses-of-biothrax-to-the-us-government-ahead-of-schedule/' rel='bookmark' title='Permanent Link: Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule'>Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule</a> <small>ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/07/07/singapore-health-sciences-authority-approves-emergent-biosolutions-anthrax-vaccine-biothrax/' rel='bookmark' title='Permanent Link: Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax'>Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax</a> <small>ROCKVILLE, Md., &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced on June...</small></li><li><a href='http://fuad-elhibri.org/2011/10/14/fuad-el-hibri-announces-emergent-biosolutionsaward-to-supply-biothrax-anthrax-vaccine-to-u-s-government/' rel='bookmark' title='Permanent Link: Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government'>Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government</a> <small>Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...</small></li></ol>

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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., Jun 09, 2011 &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational anthrax vaccine, <a href="http://socialmedia.trademarkia.com/nuthrax-85139770.html">NuThrax<sup>TM</sup></a> (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted <a href="http://en.wikipedia.org/wiki/FDA_Fast_Track_Development_Program">Fast Track Designation</a> by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also known as AV7909, consists of BioThrax<sup>(R)</sup> (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatoryoligodeoxynucleotide compound, CPG 7909, and is currently being evaluated in a Phase 1b clinical trial for safety, tolerability, and immunogenicity. The FDA&#8217;s Fast Track Development Program provides for expedited regulatory review of drugs and biologics that treat serious or life threatening diseases and that demonstrate the potential to address unmet medical needs.</p>
<p>&#8220;Emergent is pleased to receive Fast Track Designation for NuThrax,&#8221; said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. &#8220;Expedited regulatory review could mean more frequent communications with FDA, priority review of <a href="http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/default.htm">Biologics License Applications (BLA)</a> for our vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.&#8221;</p>
<p>The Phase 1b trial for NuThrax is being conducted with support from a development contract that is jointly administered under contract number HHSN272200800051C by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions, led by Chairman and CEO <a href="http://fuad-elhibri.com/">Fuad El-Hibri</a>, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent&#8217;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><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 2011, and any other statements containing the words &#8220;believes&#8221;, &#8220;expects&#8221;, &#8220;anticipates&#8221;, &#8220;plans&#8221;, &#8220;estimates&#8221;, &#8220;may&#8221;, &#8220;would&#8221;, &#8220;will&#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 the success of our preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the rate and degree of market acceptance 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 plans to pursue label expansions and improvements for BioThrax; 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&#8217;s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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>


<p>Related posts:<ol><li><a href='http://fuad-elhibri.org/2011/06/07/emergent-biosolutions-on-track-to-complete-delivery-of-14-5m-doses-of-biothrax-to-the-us-government-ahead-of-schedule/' rel='bookmark' title='Permanent Link: Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule'>Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule</a> <small>ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions...</small></li><li><a href='http://fuad-elhibri.org/2011/07/07/singapore-health-sciences-authority-approves-emergent-biosolutions-anthrax-vaccine-biothrax/' rel='bookmark' title='Permanent Link: Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax'>Singapore Health Sciences Authority Approves Emergent BioSolutions Anthrax Vaccine, BioThrax</a> <small>ROCKVILLE, Md., &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced on June...</small></li><li><a href='http://fuad-elhibri.org/2011/10/14/fuad-el-hibri-announces-emergent-biosolutionsaward-to-supply-biothrax-anthrax-vaccine-to-u-s-government/' rel='bookmark' title='Permanent Link: Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government'>Fuad El-Hibri Announces Emergent BioSolutionsAward to Supply BioThrax Anthrax Vaccine to U.S. Government</a> <small>Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions...</small></li></ol></p>
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		<title>Emergent BioSolutions on Track to Complete Delivery of 14.5M Doses of BioThrax to the US Government Ahead of Schedule</title>
		<link>http://fuad-elhibri.org/2011/06/07/emergent-biosolutions-on-track-to-complete-delivery-of-14-5m-doses-of-biothrax-to-the-us-government-ahead-of-schedule/</link>
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		<pubDate>Tue, 07 Jun 2011 14:41:28 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<description><![CDATA[ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced today that eight lots of BioThrax(R) (Anthrax Vaccine Adsorbed) have received regulatory release for delivery to the U.S. government under the company&#8217;s contract (200-2009-30162) originally written to supply 14.5 million doses of BioThrax to the Strategic National Stockpile. This marks the largest [...]


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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., May 31, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutions Inc. (NYSE:EBS) announced today that eight lots of <a href="http://biothrax.com/">BioThrax</a><sup>(R)</sup> (Anthrax Vaccine Adsorbed) have received regulatory release for delivery to the U.S. government under the company&#8217;s contract (200-2009-30162) originally written to supply 14.5 million doses of BioThrax to the <a href="http://www.cdc.gov/phpr/stockpile.htm">Strategic National Stockpile</a>. This marks the largest single-week regulatory release of product for delivery in the company&#8217;s history. The company expects to complete delivery of the 14.5 million doses as early as June, approximately three months ahead of the schedule originally set forth in the contract. BioThrax is the only vaccine licensed by the <a href="http://www.fda.gov/">U.S. Food and Drug Administration (FDA)</a> to protect against anthrax infection.</p>
<p>&#8220;Emergent is pleased with its progress towards early completion of its original procurement contract to supply 14.5 million doses of BioThrax,&#8221; said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. &#8220;Upon completion of this delivery, anticipated to occur as early as June, the company will focus on delivering the additional 3.42 million doses under the modified procurement contract. With the recent request for proposal issued by the U.S. government, Emergent is also advancing discussions to supply 44.75 million doses of BioThrax over the next five years.&#8221;</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions.led by Chairman and CEO <a href="http://www.fuadelhibri.org/">Fuad El-Hibri</a>, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent&#8217;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><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> To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel. For full prescribing information, please visit <a href="http://www.biothrax.com/prescribinginformation_biothrax_us.pdf">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 2011, 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 appropriations for BioThrax<sup>(R)</sup> procurement; our ability to obtain new BioThrax<sup>(R)</sup> sales contracts or modifications to existing 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 of our products; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; and other factors identified in the company&#8217;s Quarterly Report on Form 10-Q for the quarter ended March 31, 2011 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>Emergent BioSolutions Reports Financial Results for First Quarter 2011</title>
		<link>http://fuad-elhibri.org/2011/05/12/emergent-biosolutions-reports-financial-results-for-first-quarter-2011/</link>
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		<pubDate>Thu, 12 May 2011 10:52:35 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<description><![CDATA[ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutionsInc. (NYSE: EBS) announced  its financial results for the first quarter ended March 31, 2011.
For 1Q 2011, total revenues were $18.5 million as compared to $46.8 million in 2010. In addition, for 1Q 2011 the company recorded a net loss of $21.4 million, or $0.61 per [...]


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			<content:encoded><![CDATA[<p>ROCKVILLE, Md., May 05, 2011 (BUSINESS WIRE) &#8212; Emergent BioSolutionsInc. (NYSE: EBS) announced  its financial results for the first quarter ended March 31, 2011.</p>
<p>For 1Q 2011, total revenues were $18.5 million as compared to $46.8 million in 2010. In addition, for 1Q 2011 the company recorded a net loss of $21.4 million, or $0.61 per basic share, as compared to net income of $2.5 million, or $0.08 per basic share, in 2010.</p>
<p>R. Don Elsey, chief financial officer of Emergent BioSolutions, stated, &#8220;While our first quarter revenues were slightly lower than expected, we remain on track to achieve our full year guidance of total revenues of $320 to $340 million and net income of $35 to $45 million.&#8221;</p>
<p><strong>1Q 2011 Key Financial Results</strong></p>
<p><strong><em>Product Sales</em></strong></p>
<p>For 1Q 2011, product sales were $5.6 million, a decrease of $33.3 million, or 86 percent, from $38.9 million for 1Q 2010. This decrease was primarily due to an 88 percent decrease in the number of doses of BioThrax delivered. During the first quarter, the company redeployed its potency testing capacity from BioThrax release testing to qualification of replacement reference standards and other development testing. This process, which is required to enable continued future release of BioThrax doses, has now been substantially completed. Product sales revenues for 1Q 2011 consisted of BioThrax sales to CDC of $5.0 million and aggregate international and other sales of $0.6 million.</p>
<p><strong><em>Contracts and Grants Revenues</em></strong></p>
<p>For 1Q 2011, contracts and grants revenues were $12.9 million, an increase of $5.0 million, or 63 percent, from $7.9 million for 1Q 2010. The increase was primarily due to revenues from the recently awarded contract from BARDA for large-scale manufacturing for BioThrax, collaborations with <a href="http://www.abbott.com/index2.htm">Abbott</a> and <a href="http://www.pfizer.com/home/">Pfizer</a>, along with increased activity and associated revenue from development contracts with <a href="http://www.phe.gov/about/barda/Pages/default.aspx">BARDA</a> and <a href="http://www.niaid.nih.gov/Pages/default.aspx">NIAID</a>.</p>
<p><strong><em>Cost of Product Sales</em></strong></p>
<p>For 1Q 2011, cost of product sales was $1.1 million, a decrease of $6.4 million, or 86 percent, from $7.5 million for 1Q 2010. This decrease was primarily attributable to the 88 percent decrease in the number of BioThrax doses sold.</p>
<p><strong><em>Research and Development</em></strong></p>
<p>For 1Q 2011, research and development expenses were $34.8 million, an increase of $14.8 million, or 74 percent, from $19.9 million for 1Q 2010. This increase primarily reflects higher contract service and personnel costs, and includes increased expenses of $13.9 million on product candidates and technology platform development activities associated with the BioSciences segment and increased expenses of $0.9 million on product candidates associated with the BioDefense segment. Net of development contracts and grants reimbursement revenue along with the net loss attributable to noncontrolling interests, research and development expenses were $20.0 million for 1Q 2011.</p>
<p><strong><em>Selling, General and Administrative</em></strong></p>
<p>For 1Q 2011, selling, general and administrative expenses were $18.2 million, an increase of $2.0 million, or 12 percent, from $16.2 million for 1Q 2010. This increase is primarily due to increased personnel-related expenses and professional services to support the business. Selling, general and administrative expenses for 1Q 2011 consisted of $14.0 million associated with the BioDefense segment and $4.2 million associated with the BioSciences segment.</p>
<p><strong><em>Financial Condition and Liquidity</em></strong></p>
<p>Cash and cash equivalents combined with investments at March 31, 2011 was $143.3 million compared to $171.0 million at December 31, 2010. Additionally, at March 31, 2011, the accounts receivable balance was $12.0 million, which is comprised primarily of unpaid amounts under our NIAID and BARDA development contracts.</p>
<p><strong>2Q 2011 Revenue Forecast</strong></p>
<p>For the second quarter of 2011, the company anticipates total revenues of $80 to $90 million.</p>
<p><strong>2011 Forecast</strong></p>
<p>For full year 2011, the company is reaffirming its financial forecast of total revenues of $320 to $340 million and net income of $35 to $45 million.</p>
<p>2011 total revenue is expected to be driven by, among other things:</p>
<ul>
<li>the continuation of deliveries of BioThrax under the      current multi-year procurement contract with CDC, which was recently      modified to increase the total contracted doses to 17.9 million;</li>
<li>additional deliveries of BioThrax under a follow-on,      multi-year procurement contract with CDC, anticipated to begin in 4Q 2011;</li>
<li>a significant increase in contracts and grants revenue      based primarily on development contracts related to product development      programs in the company&#8217;s BioDefense segment; and</li>
<li>collaboration and milestone revenues associated with      achievement of clinical development milestones related to the company&#8217;s      oncology product candidate, which is under an existing co-development      agreement with Abbott, and the company&#8217;s autoimmune product candidate,      which is being developed by Pfizer under a license agreement from the      company.</li>
</ul>
<p><strong>Conference Call and Webcast</strong></p>
<p>Company management hosted a conference call at 5:00 pm Eastern on May 5, 2011 to discuss the financial results for the first quarter of 2011, recent business developments, revenue guidance for the second quarter of 2011 and revenue and net income guidance for the full year 2011.</p>
<p>A replay of the conference call will be accessible by dialing 888/286-8010 or 617/801-6888 and using the passcode 12159691. The replay will be available through May 19, 2011. The webcast will be archived on the company&#8217;s website, <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a>, under &#8220;Investors&#8221;.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions, led by Chairman and CEO, <a href="http://investing.businessweek.com/research/stocks/people/person.asp?personId=5875211&amp;ticker=EBS:AV">Fuad El-Hibri,</a> protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent&#8217;s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information may be found at <a href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</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 estimates of preliminary results for 2010, and our expected revenue growth and net earnings for 2011, 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 appropriations for BioThrax<sup>(R)</sup> procurement; our ability to obtain new BioThrax<sup>(R)</sup> sales contracts or modifications to existing contracts; our plans to pursue label expansions and improvements for BioThrax<sup>(R)</sup>; our ability to perform under our current development contracts with the U.S. government; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance of our products and product candidates; the success of preclinical studies and clinical trials of our product candidates and post-approval clinical utility of our products; the potential benefits of our existing collaborations and our ability to selectively enter into additional collaborative arrangements; ongoing and planned development programs, preclinical studies and clinical trials; and other factors identified in the company&#8217;s Annual Report on Form 10-K for the year ended December 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>Emergent BioSolutions Reports Financial Results for Full Year 2010</title>
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		<pubDate>Wed, 13 Apr 2011 09:28:09 +0000</pubDate>
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		<description><![CDATA[
2010 revenues of $286.2 million
2010 net income of $51.7 million, or $1.63 per share, representing ninth consecutive year of profitability
2010 cash, investments and accounts receivable balance of $210.4 million
2011 forecast reaffirmed: total revenues of $320 to $340 million and net income of $35 to $45 million

Emergent BioSolutions Inc. (NYSE: EBS) announced on 10 March its [...]


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			<content:encoded><![CDATA[<ul type="disc">
<li>2010 revenues of $286.2 million</li>
<li>2010 net income of $51.7 million, or $1.63 per share, representing ninth consecutive year of profitability</li>
<li>2010 cash, investments and accounts receivable balance of $210.4 million</li>
<li>2011 forecast reaffirmed: total revenues of $320 to $340 million and net income of $35 to $45 million</li>
</ul>
<p><a href="http://www.emergentbiosolutions.com">Emergent BioSolutions Inc</a>. (NYSE: EBS) announced on 10 March its financial results for the full year  ending December 31, 2010. </p>
<p>Total revenues for 2010 were $286.2  million as compared to $234.8 million in 2009, and net income was $51.7  million, or $1.63 per basic share, as compared to $31.1 million, or $1.02 per  basic share, in 2009. </p>
<p>For the fourth quarter 2010, total  revenues were $103.2 million as compared to $53.8 million in 2009, and net  income was $26.2 million, or $0.78 per basic share, as compared to $4.2  million, or $0.14 per basic share, in 2009. </p>
<p>R. Don Elsey, chief financial  officer of Emergent BioSolutions, stated, &quot;Our 2010 financial performance  reflects our continued success in growing revenue from the sale of <a href="http://www.biothrax.com/">BioThrax</a>(R) and  government development contracts, as well as from development collaborations  with our large pharma partners. We achieved this revenue growth while closely  managing our overall expenditures even as we continued to advance our pipeline  of vaccines and therapeutics targeting key disease areas. We expect to continue  our growth in 2011, as evidenced by our reaffirmed 2011 forecast of total  revenues of $320 to $340 million and net income of $35 to $45 million.&quot; </p>
<p><strong>2010 Key Operational Accomplishments</strong> </p>
<ul type="disc">
<li>Acquired <a href="http://www.truemergent.com/">Trubion Pharmaceuticals, Inc.</a> for a total consideration of up to $131.6 million, including $92.9 million in upfront cash and stock and up to $38.7 million of success-based milestones, payable between October 2010 and October 2013; </li>
<li>Secured a <a href="http://www.phe.gov/about/barda/Pages/default.aspx">BARDA</a> development contract, valued at up to $107.0 million, to fund qualification, validation and licensure of Building 55 in order to manufacture BioThrax(R) (Anthrax Vaccine Adsorbed) at large-scale; </li>
<li>Secured a BARDA development contract, valued at up to $186.6 million, to fund development of our rPA vaccine candidate       PreviThraxTM (Recombinant Protective Antigen Anthrax Vaccine, Purified); </li>
<li>Secured a <a href="http://funding.niaid.nih.gov/researchfunding/contract/pages/about.aspx">NIAID development contract</a>, valued at up to $28.7 million, to fund further development of NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), the second contract award for this vaccine candidate; </li>
<li>Launched Singapore operations and formed EPIC Bio, Pte. Ltd., a joint venture with <a href="http://www.tlv.sg/">Temasek Life Sciences Ventures</a> Pte. Ltd., to develop, manufacture, and commercialize pre-pandemic influenza vaccines and therapeutics; </li>
<li>Obtained <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm">Fast Track designation</a> and <a href="http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm">Orphan Drug status</a> from FDA for ThravixaTM (Fully Human Anthrax Monoclonal Antibody); </li>
<li>Initiated a Phase 1 clinical study for Thravixa; </li>
<li>Initiated a Phase 1 clinical study for NuThrax; and </li>
</ul>
<p>Expanded  the Board of Directors with the appointment of John E. Niederhuber, M.D.,  former Director, The National Cancer Institute (NCI), and Marvin White, Chief  Financial Officer, St. Vincent Health and former Chief Financial Officer,  LillyUSA.</p>
<p><strong>About Emergent BioSolutions Inc.</strong></p>
<p>Emergent BioSolutions, led by Chairman and CEO<a href="http://www.webbiographies.com/JournalViewVisitor.do?method=view&amp;visitingbioid=31678&amp;chapterid=471793&amp;journalid=8352#8352">Fuad  El-Hibri</a>, protects and enhances life by developing and manufacturing vaccines  and therapeutics that are supplied to healthcare providers and purchasers for  use in preventing and treating disease. Emergent&#8217;s marketed and investigational  products target infectious diseases, oncology and autoimmune disorders.  Additional information may be found at <a href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.emergentbiosolutions.com&amp;esheet=6643305&amp;lan=en-US&amp;anchor=www.emergentbiosolutions.com&amp;index=3&amp;md5=974c9d419f86092b960b6d8622d54f18">http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.emergentbiosolutions.com&amp;esheet=6643305&amp;lan=en-US&amp;anchor=www.emergentbiosolutions.com&amp;index=3&amp;md5=974c9d419f86092b960b6d8622d54f18</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 estimates  of preliminary results for 2010, and our expected revenue growth and net  earnings for 2011, and any other statements containing the words  &quot;believes&quot;, &quot;expects&quot;, &quot;anticipates&quot;,  &quot;plans&quot;, &quot;estimates&quot; 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 appropriations for BioThrax(R)  procurement; our ability to obtain new BioThrax(R) sales contracts  or modifications to existing contracts; our plans to pursue label expansions  and improvements for BioThrax(R); our ability to perform under our  current development contracts with the U.S. government; our plans to expand our  manufacturing facilities and capabilities; the rate and degree of market  acceptance of our products and product candidates; the success of preclinical  studies and clinical trials of our product candidates and post-approval  clinical utility of our products; the potential benefits of our existing  collaborations and our ability to selectively enter into additional  collaborative arrangements; ongoing and planned development programs,  preclinical studies and clinical trials; and other factors identified in the  company&#8217;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>


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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>
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		<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 Revises Upward 2010 Financial Forecast</title>
		<link>http://fuad-elhibri.org/2010/08/03/emergent-revises-upward-2010-financial-forecast/</link>
		<comments>http://fuad-elhibri.org/2010/08/03/emergent-revises-upward-2010-financial-forecast/#comments</comments>
		<pubDate>Tue, 03 Aug 2010 09:45:59 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Anthrax]]></category>
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		<category><![CDATA[fuad el-hibri]]></category>
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		<category><![CDATA[Strategic National Stockpile]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=245</guid>
		<description><![CDATA[Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million
ROCKVILLE, MD, July 20, 2010 – Emergent BioSolutions  Inc. (NYSE:EBS) announced today that it is revising upwards its 2010  annual guidance to now reflect anticipated total revenues of $275 to  $300 million and net income of [...]


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			<content:encoded><![CDATA[<p><strong>Company anticipates total revenues of $275 to $300 million and net income of $40 to $50 million</strong></p>
<p><strong>ROCKVILLE, MD, July 20, 2010</strong> – Emergent BioSolutions  Inc. (NYSE:EBS) announced today that it is revising upwards its 2010  annual guidance to now reflect anticipated total revenues of $275 to  $300 million and net income of $40 to $50 million.  Of the anticipated  total revenues of $275 to $300 million, $165 to $190 million is expected  to be recognized in the second half of 2010.  This revised forecast  does not reflect or incorporate any revenue impact from a possible  development contract for the company’s rPA vaccine candidate.</p>
<p>The revision to the 2010 financial forecast is supported primarily by the recent modification to the company’s current BioThrax<sup>®</sup> procurement contract with the US Centers for Disease Control and  Prevention (CDC).  This contract modification increased the number of  doses of BioThrax that the company can deliver into the Strategic  National Stockpile (SNS) during calendar 2010.  This increased volume of  available doses of BioThrax is due to consistently high production  yields throughout 2010.</p>
<p>“This modification by the CDC to our existing BioThrax procurement  contract reinforces, yet again, the US government’s commitment to  BioThrax as a critical component of the Strategic National Stockpile and  to our nation’s defense against bioterrorism,” said <a onclick="javascript:pageTracker._trackPageview('/outbound/article/investors.emergentbiosolutions.com');" href="http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&amp;p=irol-govBio&amp;ID=158319" target="_blank">Fuad El-Hibri</a>,  chairman and chief executive officer of Emergent.  “This is another  example of how we continue to work with our US government partners in  establishing BioThrax as the backbone of our readiness against the  threat of anthrax and to building a stockpile as rapidly as possible.”</p>
<p>Daniel J. Abdun-Nabi, president and chief operating officer of  Emergent, also commented, “The production yields we have been  experiencing are a direct result of our commitment to driving innovation  in our manufacturing process and to a multi-year initiative focused on  process optimization of the existing Building 12 production facility.   We are extremely pleased with the results of our continuous process  improvement program for BioThrax and expect this program to drive the  maintenance of positive production metrics going forward.”</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>About BioThrax<sup>®</sup></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 45 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/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>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; 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 manufacturing success rates; 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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		<title>Maryland Governor Martin O’Malley Leads Ribbon Cutting Ceremony at Emergent’s Baltimore Manufacturing Facility</title>
		<link>http://fuad-elhibri.org/2010/07/27/maryland-governor-martin-o%e2%80%99malley-leads-ribbon-cutting-ceremony-at-emergent%e2%80%99s-baltimore-manufacturing-facility/</link>
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		<pubDate>Tue, 27 Jul 2010 08:37:49 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Biothrax]]></category>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=241</guid>
		<description><![CDATA[ROCKVILLE, MD, July 16,  2010 – Emergent   BioSolutions Inc. (NYSE:EBS) today held a  ribbon cutting ceremony, led   by Governor Martin O’Malley and Fuad El-Hibri,  Emergent’s chairman and   chief executive officer, to mark the formal opening of  Emergent   Manufacturing Operations Baltimore.  Emergent’s new facility [...]


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			<content:encoded><![CDATA[<p><strong>ROCKVILLE, MD, July 16,  2010</strong> – Emergent   BioSolutions Inc. (NYSE:EBS) today held a  ribbon cutting ceremony, led   by Governor Martin O’Malley and <a href="http://www.emergentbiosolutions.com/">Fuad El-Hibri</a>,  Emergent’s chairman and   chief executive officer, to mark the formal opening of  Emergent   Manufacturing Operations Baltimore.  Emergent’s new facility  consists   of 56,000 square feet of manufacturing and office space, and includes    multiple manufacturing suites designed to support clinical and   commercial  manufacture of the company’s rPA, anthrax monoclonal, and   tuberculosis product  candidates, among others.</p>
<p>“The  Baltimore  facility symbolizes Emergent’s continued investment   in manufacturing as one of  its core competencies and competitive   advantages,” said Mr. El-Hibri.  “It  is also a testament to Emergent’s   commitment to the State of Maryland, where we are  proud to be a key   contributor to economic development and job growth.”</p>
<p>“Maryland has a reputation of being a haven for  thriving life   sciences and biotechnology companies, thanks to industry leaders  like   Emergent BioSolutions,” said Governor O’Malley. “Emergent’s expansion   into  Baltimore, through the purchase and  re-commissioning of this   facility, enables significant investment in the biotech  infrastructure   already in place and ensures that high-paying, highly-skilled  jobs are   created and remain in Maryland.”</p>
<div id="attachment_242" class="wp-caption aligncenter" style="width: 310px"><img class="size-medium wp-image-242" title="Maryland Governor Martin O'Malley and Fuad El-Hibri" src="http://fuad-elhibri.org/wp-content/uploads/2010/07/Gov.-OMalley-and-Fuad-300x238.jpg" alt="Maryland Governor Martin O'Malley and Fuad El-Hibri" width="300" height="238" /><p class="wp-caption-text">Maryland Governor Martin O&#39;Malley and Fuad El-Hibri</p></div>
<p>Emergent employs over 680 employees across the globe,  with 180   employees located in Maryland, where,  aside from the Baltimore   manufacturing facility, its corporate  headquarters and one of its   product development sites are located.  The  opening of this new   facility could create an additional 120 jobs in the next  five years.</p>
<p>“The  opening of this new biopharmaceutical facility is good news for   three reasons:  jobs, jobs and more jobs for Maryland,” said Senator   Barbara  Mikulski<strong> </strong>(MD-D). “To keep our  state   competitive in the global economy, we have to create and support    Maryland’s  jobs of the future, like the innovative  life sciences jobs   at Emergent BioSolutions. I’m proud that  East Baltimore has been   selected to house a  facility dedicated to research that will keep   Americans healthy and safe.”</p>
<p>“I’m  pleased to welcome Emergent BioSolutions to Baltimore,” said   Congressman John Sarbanes  (MD-D).  “This manufacturing facility helps   Maryland maintain its status as a leader in  the bioscience industry and   brings more than 100 high paid, high skilled jobs  for Marylanders.”</p>
<p>“Baltimore  City is excited about Emergent  BioSolutions’ decision to   invest here, which will create many jobs and  contribute a great deal   to the Baltimore biotech industry,” Baltimore Mayor  Stephanie   Rawlings-Blake said.  “I welcome Emergent BioSolutions to  Baltimore   City and look forward to the company’s growth in one  of Baltimore’s    key industries.”</p>
<p>The  company is currently working on modifying and re-commissioning   the  facility.  Planned facility modifications will allow for the   utilization of  disposable manufacturing technology to potentially   result in lower capital  investments, lower operating costs, and   accelerated process development  timelines.  The facility previously   operated as a Food and Drug  Administration (FDA) licensed facility used   by an experienced contract  manufacturing organization to produce a   number of products approved by the FDA  and the European Medicines   Agency.</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 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&amp;esheet=6257694&amp;lan=en_US&amp;anchor=www.emergentbiosolutions.com&amp;index=4&amp;md5=dbd4bd5ebd31e5fca08bcedf78989c4a" target="_blank">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 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; 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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		<title>Emergent BioSolutions Awarded HHS Contract Valued at Up to $107 Million to Develop Large-Scale Manufacturing for BioThrax</title>
		<link>http://fuad-elhibri.org/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 14:59:22 +0000</pubDate>
		<dc:creator>admin</dc:creator>
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		<guid isPermaLink="false">http://fuad-elhibri.org/?p=239</guid>
		<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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		<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>
		<dc:creator>admin</dc:creator>
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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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