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><channel><title>Chris Abraham &#187; Food and Drug Administration</title> <atom:link href="http://chrisabraham.com/tag/food-and-drug-administration/feed/" rel="self" type="application/rss+xml" /><link>http://chrisabraham.com</link> <description>Because the Medium is the Message</description> <lastBuildDate>Sun, 27 May 2012 03:06:01 +0000</lastBuildDate> <language>en</language> <sy:updatePeriod>hourly</sy:updatePeriod> <sy:updateFrequency>1</sy:updateFrequency> <generator>http://wordpress.org/?v=3.3.2</generator> <xhtml:meta xmlns:xhtml="http://www.w3.org/1999/xhtml" name="robots" content="noindex" /> <item><title>Washington Emergent BioSolutions on rPA Vaccine</title><link>http://chrisabraham.com/2009/12/09/washington-emergent-biosolutions-on-rpa-vaccine/</link> <comments>http://chrisabraham.com/2009/12/09/washington-emergent-biosolutions-on-rpa-vaccine/#comments</comments> <pubDate>Wed, 09 Dec 2009 23:16:34 +0000</pubDate> <dc:creator>Chris Abraham</dc:creator> <category><![CDATA[Anthrax Vaccine]]></category> <category><![CDATA[BAA]]></category> <category><![CDATA[bio technology]]></category> <category><![CDATA[biotech]]></category> <category><![CDATA[Development of rPA Vaccines]]></category> <category><![CDATA[EBS]]></category> <category><![CDATA[Emergent]]></category> <category><![CDATA[Emergent BioSolutions]]></category> <category><![CDATA[Fuad El-Hibri]]></category> <category><![CDATA[HHS Cancels RFP]]></category> <category><![CDATA[rPA Procurement]]></category> <category><![CDATA[US FDA license]]></category> <category><![CDATA[Washington area]]></category> <category><![CDATA[BARDA]]></category> <category><![CDATA[Centers for Disease Control and Prevention]]></category> <category><![CDATA[Federal government of the United States]]></category> <category><![CDATA[Food and Drug Administration]]></category> <category><![CDATA[Private Securities Litigation Reform Act]]></category> <category><![CDATA[Project Bioshield Act]]></category> <category><![CDATA[Strategic National Stockpile]]></category><guid
isPermaLink="false">http://chrisabraham.com/?p=8252</guid> <description><![CDATA[Back after the DOT-COM bomb in 2000 people were looking for the next thing.  Many in the Metro Washington area were sure it would be bio technology but that quickly seemed to go nowhere.  Or did it?  Well, not really.  Lots of money, research, investment, and brain power did indeed go into biotech and executives [...]]]></description> <content:encoded><![CDATA[<p></p><div
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border="0" style="border:0;" src="//assets.pinterest.com/images/PinExt.png" title="Pin It" alt="PinExt Washington Emergent BioSolutions on rPA Vaccine" /></a></div><p>Back after the DOT-COM bomb in 2000 people were looking for the next thing.  Many in the Metro Washington area were sure it would be bio technology but that quickly seemed to go nowhere.  Or did it?  Well, not really.  Lots of money, research, investment, and brain power did indeed go into biotech and executives like <a
href="http://en.wikipedia.org/wiki/Fuad_El-Hibri">Fuad El-Hibri</a> have created companies like <a
title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">Emergent BioSolutions</a> all over the are.  Well, maybe not exactly like Emergent because they hold the only US FDA license for the <a
class="zem_slink" title="Anthrax vaccines" rel="wikipedia" href="http://en.wikipedia.org/wiki/Anthrax_vaccines">Anthrax Vaccine</a>.  Well, a couple days ago some news hit the wire: <a
href="http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&amp;newsId=20091207006413&amp;newsLang=en">HHS Cancels RFP for rPA Procurement and Modifies Their Approach in Favor of BAA for Development of rPA Vaccines</a>.</p><p><span
id="more-8252"></span></p><blockquote><p><strong><a
href="http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&amp;newsId=20091207006413&amp;newsLang=en">HHS Cancels RFP for rPA Procurement and Modifies Their Approach in Favor of BAA for Development of rPA Vaccines</a><br
/> </strong><br
/> <a
class="zem_slink" title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">Emergent BioSolutions</a> Inc. (NYSE:EBS) announced today that it has been advised by the Office of 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) that the Request for Proposal (RFP) for the procurement of rPA vaccines has been cancelled in favor of a Broad Agency Announcement (BAA) for rPA vaccine development. According to BARDA officials, BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the <a
class="zem_slink" title="Project Bioshield Act" rel="wikipedia" href="http://en.wikipedia.org/wiki/Project_Bioshield_Act">Project BioShield</a> statutory requirement of having a product ready for licensure within 8 years.</p><p>Simultaneously, BARDA issued an amendment to BAA 09-34 to enable companies to submit proposals to obtain development funding for rPA vaccine candidates. The due date for all proposals is February 1, 2010.</p><p>During a meeting with company officials today, BARDA strongly encouraged Emergent to submit a proposal to this BAA. Emergent intends to submit its proposal by the end of this year.</p><p>This decision by BARDA has no impact on the company’s $400 million procurement contract with the Centers for Disease Control and Prevention (CDC) for the manufacture and delivery of 14.5 million doses of BioThrax ® into the <a
class="zem_slink" title="Strategic National Stockpile" rel="homepage" href="http://www.bt.cdc.gov/stockpile/index.asp">Strategic National Stockpile</a> (SNS). The company is currently delivering BioThrax under this contract and expects to complete deliveries by September 2011. BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease.</p><p>&#8220;With this action, BioThrax remains a critical and long-term countermeasure for the US government,&#8221; said <a
href="http://en.wikipedia.org/wiki/Fuad_El-Hibri">Fuad El-Hibri</a>, chairman and <a
class="zem_slink" title="Chief executive officer" rel="wikipedia" href="http://en.wikipedia.org/wiki/Chief_executive_officer">chief executive officer</a> of Emergent BioSolutions. &#8220;In addition, based upon encouragement by the USG, we believe our rPA vaccine is well-positioned to obtain a development contract under this BAA. Our anthrax franchise solidifies Emergent as a leader in the development and supply of anthrax medical countermeasures.&#8221;</p><p>Emergent has recently resumed BioThrax scale-up activities within its new 50,000 sq. ft. state-of-the-art manufacturing facility in Lansing.</p><p>In addition, BARDA and Emergent are in discussions for a separate contract under which BARDA would fund scale-up and related activities to obtain FDA licensure for large-scale production of BioThrax in this new facility. This new facility is designed as a campaignable, multi-product facility capable of producing up to 30 million doses of BioThrax per annum. With the addition of a second train, the capacity of the facility could be doubled to up to 60 million doses per annum.</p><p>&#8220;This is an exciting development because it positions BioThrax as the sole <a
class="zem_slink" title="Anthrax vaccines" rel="wikipedia" href="http://en.wikipedia.org/wiki/Anthrax_vaccines">anthrax vaccine</a> for USG procurement for at least the next eight years,&#8221; said Daniel J. Abdun-Nabi, president and chief operating officer, Emergent BioSolutions. &#8220;We believe that BioThrax will remain a premier product based on its recent enhancements, such as four-year dating, a reduced vaccination schedule and intramuscular route of administration, together with the potential for a further reduction in the vaccination schedule to a 3-dose primary series with a 3-year boost.</p><p>BioThrax continues to be the product of choice for the USG and other customers seeking to address the anthrax threat.&#8221;</p><p>About Emergent BioSolutions Inc.<br
/> Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax ® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the <a
class="zem_slink" title="Food and Drug Administration (United States)" rel="homepage" href="http://www.fda.gov/">U.S. Food and Drug Administration</a> for the prevention of anthrax disease. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com : and www.biothrax.com : .</p><p>Safe Harbor Statement<br
/> This press release includes forward-looking statements within the meaning of the <a
class="zem_slink" title="Private Securities Litigation Reform Act" rel="wikipedia" href="http://en.wikipedia.org/wiki/Private_Securities_Litigation_Reform_Act">Private Securities Litigation Reform Act of 1995</a>. 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 2009, 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’s actual results to differ materially from those indicated by such forward-looking statements, including appropriations for BioThrax ® procurement; our ability to obtain new BioThrax ® sales contracts; our plans to pursue label expansions and improvements for BioThrax ® ; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the success of 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 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, 2009 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>Emergent BioSolutions Inc.Investors Contact:Robert G.</p><p>BurrowsVice President, Investor Relations301-795-1877 BurrowsR@ebsi.com : mailto:BurrowsR@ebsi.com orMedia<br
/> Contact:Tracey SchmittVice President, Corporate</p><p>Communications301-795-1800 SchmittT@ebsi.com : mailto:SchmittT@ebsi.com</p></blockquote><div
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isPermaLink="false">http://chrisabraham.com/?p=7914</guid> <description><![CDATA[Emergent acquires manufacturing facility from MdBio and land from City of Baltimore for $8.2 million ROCKVILLE, MD, November 13, 2009 – Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has completed the acquisition of a 55,000 square foot manufacturing facility from MdBio Foundation and the land on which the facility stands from the City of [...]]]></description> <content:encoded><![CDATA[<p></p><div
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border="0" style="border:0;" src="//assets.pinterest.com/images/PinExt.png" title="Pin It" alt="PinExt Emergent BioSolutions Enhances Manufacturing Infrastructure with Strategic Acquisition in Baltimore" /></a></div><p><em>Emergent acquires manufacturing facility from MdBio and land from City of Baltimore for $8.2 million</em></p><p><strong>ROCKVILLE, MD, November 13, 2009</strong> – <a
title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">Emergent BioSolutions</a> Inc. (NYSE:EBS) announced today that it has completed the acquisition of a 55,000 square foot manufacturing facility from MdBio Foundation and the land on which the facility stands from the City of Baltimore for a total purchase price of $8.2 million.  The facility, located within the City of <a
title="Baltimore" rel="geolocation" href="http://maps.google.com/maps?ll=39.2833333333,-76.6166666667&amp;spn=0.1,0.1&amp;q=39.2833333333,-76.6166666667%20%28Baltimore%29&amp;t=h">Baltimore, Maryland</a>, previously operated as a Food and Drug Administration (FDA) licensed facility used by an experienced contract manufacturing organization (CMO) to produce a number of FDA approved products.</p><p><img
title="More..." src="http://chrisabraham.com/wp-content/uploads/2009/11/trans.gif" alt="trans Emergent BioSolutions Enhances Manufacturing Infrastructure with Strategic Acquisition in Baltimore"  />“Emergent is excited about this new facility in Baltimore because it houses several suites capable of manufacturing multiple products at the same time,” said <a
title="Fuad El-Hibri" rel="wikipedia" href="http://en.wikipedia.org/wiki/Fuad_El-Hibri">Fuad El-Hibri</a>, chairman and <a
title="Chief executive officer" rel="wikipedia" href="http://en.wikipedia.org/wiki/Chief_executive_officer">chief executive officer</a> of <a
title="NYSE: EBS" rel="stockexchange" href="http://finance.yahoo.com/q?s=EBS">Emergent BioSolutions</a>.  “Accordingly, this facility will provide the flexibility to conduct large-scale manufacturing of rPA while also producing other products in our pipeline.”</p><p><span
id="more-7914"></span></p><p>Emergent worked closely with the Maryland Department of Business and Economic Development (DBED), MdBio, the City of Baltimore, Baltimore Development Corporation, and other related governmental agencies to complete this transaction.</p><p>“Maryland is continuing to strengthen its biotechnology prowess by helping to grow industry leaders like Emergent BioSolutions,” said Governor <a
title="Martin O'Malley" rel="wikipedia" href="http://en.wikipedia.org/wiki/Martin_O%27Malley">Martin O’Malley</a>. “The transaction between MdBio and Emergent will maximize the value of the BioProcessing Center by maintaining a bio-manufacturing infrastructure for Maryland’s bioscience community, enabling additional investment to be made in the Center and ensuring that those high paying, highly skilled jobs are created and remain in Maryland.”</p><p>Emergent BioSolutions employs over 600 employees across the globe, with over 150 employees located in its corporate headquarters in Rockville and one of its product development sites in Gaithersburg.</p><p>“This acquisition reflects our commitment to both continually creating jobs and investing additional capital in the State of Maryland,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.  “We extend our sincere appreciation to the state and local governments for their ongoing support of our efforts to develop our local manufacturing capabilities and look forward to growing Emergent’s presence in the state.”</p><p>Mayor Sheila Dixon, commenting on the announcement, said, “The City of Baltimore is excited about welcoming Emergent BioSolutions to the Baltimore biotech community.  With great research institutions such as Johns Hopkins and the University of Maryland as potential partners in the area, we know that Emergent will be a wonderful contributor in the future.”</p><p>“Emergent’s decision to expand in Maryland underscores not only our rich <a
title="Research and development" rel="wikipedia" href="http://en.wikipedia.org/wiki/Research_and_development">research and development</a> environment, but also our mission to support the complete product development life cycle that includes bio manufacturing,” said Maryland Department of Business and Economic Development Secretary Christian S. Johansson. “The Department was pleased to work with MdBio Foundation and the Baltimore Development Corp. to bring this project to fruition.”</p><p><strong>About Emergent BioSolutions Inc.</strong><br
/> Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease.  Emergent’s marketed product, BioThrax (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the <a
title="Food and Drug Administration (United States)" rel="homepage" href="http://www.fda.gov/">U.S. Food and Drug Administration</a> for the prevention of anthrax.  Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia.  Additional information may be found at <a
href="http://www.emergentbiosolutions.com/">www.emergentbiosolutions.com</a> and <a
href="http://www.biothrax.com/">www.biothrax.com</a>.</p><p><strong>About MdBio Foundation, Inc.</strong><br
/> The MdBio Foundation, Inc. is a charitable and educational organization whose mission is to provide and support the State of Maryland’s bioscience community through bioscience awareness, education and workforce development programs including scholarships, post-doctoral conference and career expos, BioGENEius science competition and summer science camps.  Since 2003, MdBio has operated the MdBioLab, an educational and well-known mobile bioscience laboratory that visits high schools throughout Maryland to educate youth on biosciences.  Over the past six years, MdBioLab has held more than 2,800 classes with 55,000 students and 1,500 teachers. MdBio Foundation became an affiliate of the Tech Council of Maryland in 2006.</p><p><strong>Safe</strong><strong> Harbor</strong><strong> 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 2009, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain FDA approval to manufacture products or product candidates in the newly acquired facility; 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 <a
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 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 period ended September 30, 2009 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
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