<SEC-DOCUMENT>0001367644-14-000031.txt : 20140730
<SEC-HEADER>0001367644-14-000031.hdr.sgml : 20140730
<ACCEPTANCE-DATETIME>20140730082836
ACCESSION NUMBER:		0001367644-14-000031
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20140729
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20140730
DATE AS OF CHANGE:		20140730

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Emergent BioSolutions Inc.
		CENTRAL INDEX KEY:			0001367644
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				141902018
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33137
		FILM NUMBER:		141001377

	BUSINESS ADDRESS:	
		STREET 1:		2273 RESEARCH BLVD, SUITE 400
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850
		BUSINESS PHONE:		(301) 795-1800

	MAIL ADDRESS:	
		STREET 1:		2273 RESEARCH BLVD, SUITE 400
		CITY:			ROCKVILLE
		STATE:			MD
		ZIP:			20850
</SEC-HEADER>
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<TYPE>8-K
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<FILENAME>form8k07302014.htm
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 14pt; FONT-WEIGHT: bold">UNITED STATES</div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 14pt">SECURITIES AND EXCHANGE COMMISSION</font><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
</font> WASHINGTON, D.C. 20549</div>

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<div style="TEXT-ALIGN: center; MARGIN-TOP: 12pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 18pt; FONT-WEIGHT: bold">FORM 8-K</div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">CURRENT REPORT<font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
</font> Pursuant to Section 13 or 15(d) of the</div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Securities Exchange Act of 1934</div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">Date of report (Date of earliest event reported):&#160;&#160;<font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">July 29, 2014</font></div>

<div style="TEXT-ALIGN: center"><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 14pt; FONT-WEIGHT: bold">Emergent BioSolutions Inc.</font><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
</font>(Exact Name of Registrant as Specified in Charter)<font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">001-33137</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">(State or Other Jurisdiction</div>

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</font> File Number)</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">(IRS Employer<font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
</font> Identification No.)</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">2273 Research Boulevard, Suite 400, Rockville, Maryland</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">(Address of Principal Executive Offices)</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">Registrant's telephone number, including area code:&#160; <font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">(301) 795-1800</font></div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 3pt; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Not applicable</div>

<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">(Former Name or Former Address, if Changed Since Last Report)</div>

<div style="TEXT-ALIGN: left; TEXT-INDENT: 36pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):</div>

<div style="TEXT-ALIGN: left; TEXT-INDENT: 36pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">&#61551; Written communications pursuant to Rule&#160;425 under the Securities Act (17 CFR 230.425)</div>

<div style="TEXT-ALIGN: left; TEXT-INDENT: 36pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">&#61551; Soliciting material pursuant to Rule&#160;14a-12 under the Exchange Act (17 CFR 240.14a-12)</div>

<div style="TEXT-ALIGN: left; TEXT-INDENT: 36pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">&#61551; Pre-commencement communications pursuant to Rule&#160;14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</div>

<div style="TEXT-ALIGN: left; TEXT-INDENT: 36pt; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt">&#61551; Pre-commencement communications pursuant to Rule&#160;13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</div>
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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Item 8.01 Other Events.</div>

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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration has&#160;issued a complete response letter for the New Drug Application of IXINITY&#8482; [coagulation factor IX (recombinant)] for the control and prevention of bleeding episodes and perioperative management in adults and children, 12 years old and above, living with Hemophilia B.</div>

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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">The complete response letter requested additional analyses of data from completed studies and noted deficiencies in the CMC section of the license application, all of which must be resolved before approval can be granted by FDA.&#160;The company plans to engage with the FDA to better ascertain the requirements for approval, following which it will determine its next steps. The company does not anticipate launching the product in 2014.</div>

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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Safe Harbor Statement</div>

<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt; FONT-WEIGHT: bold">&#160;</div>

<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">This disclosure 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, anticipated launch of IXINITY, and any other statements containing the words "believes", "expects", "anticipates", "intends", "plans", "estimates" and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this disclosure, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances. 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 efforts to resolve the deficiencies noted by the FDA. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.</div>
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<div style="TEXT-ALIGN: center; FONT-FAMILY: ''Times New Roman'', Times, serif; MARGIN-BOTTOM: 12pt; FONT-SIZE: 10pt; FONT-WEIGHT: bold">SIGNATURE</div>

<div style="TEXT-ALIGN: left; MARGIN-BOTTOM: 12pt"><font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.<font style="FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><br>
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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">Date:&#160; July 30, 2014</div>
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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">EMERGENT BIOSOLUTIONS INC.</div>
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<div style="TEXT-ALIGN: right; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">By:</div>
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<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt"><u>/s/A.B. Cruz</u></div>

<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">A.B. Cruz</div>

<div style="TEXT-ALIGN: left; FONT-FAMILY: ''Times New Roman'', Times, serif; FONT-SIZE: 10pt">Executive Vice President, General Counsel<font style="FONT-SIZE: 6pt" id="TRGRRTFtoHTMLTab">&#160;&#160;</font>and Corporate Secretary</div>
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