<SEC-DOCUMENT>0001171843-17-000525.txt : 20170130
<SEC-HEADER>0001171843-17-000525.hdr.sgml : 20170130
<ACCEPTANCE-DATETIME>20170130080539
ACCESSION NUMBER:		0001171843-17-000525
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20170130
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170130
DATE AS OF CHANGE:		20170130

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BIOCRYST PHARMACEUTICALS INC
		CENTRAL INDEX KEY:			0000882796
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				621413174
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-23186
		FILM NUMBER:		17555393

	BUSINESS ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
		BUSINESS PHONE:		919-859-1302

	MAIL ADDRESS:	
		STREET 1:		4505 EMPEROR BOULEVARD
		STREET 2:		SUITE 200
		CITY:			DURHAM
		STATE:			NC
		ZIP:			27703
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>f8k_013017.htm
<DESCRIPTION>FORM 8-K
<TEXT>
<html><head><title></title></head><body><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;"><font style="font-size: 10pt;">&#160;</font></div></div><p style="text-align: center;"><font style="font-size: 14pt;"><strong>UNITED STATES</strong><br><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br><strong>Washington, D.C. 20549</strong><br>_____________________</font></p><p style="text-transform: uppercase; text-align: center;"><font style="font-size: 14pt;"><strong>Form 8-K</strong><br>_____________________</font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>CURRENT REPORT</strong></font></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</strong></font></p><p align="center"><font style="font-size: 10pt;">Date of Report (Date of earliest event Reported): <!--January 30, 2017-->January 30, 2017 &#160;</font></p><p align="center"><font style="font-size: 12pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font><br><font style="font-size: 10pt;">(Exact Name of Registrant as Specified in Charter)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;"><strong>Delaware</strong></font></td><td align="center" width="34%"><font style="font-size: 10pt;"><strong>000-23186</strong></font></td><td align="center" width="33%"><font style="font-size: 10pt;"><strong>62-1413174</strong></font></td></tr><tr valign="top"><td align="center" width="33%"><font style="font-size: 10pt;">(State or Other Jurisdiction of Incorporation)</font></td><td align="center" width="34%"><font style="font-size: 10pt;">(Commission File Number)</font></td><td align="center" width="33%"><font style="font-size: 10pt;">(I.R.S. Employer Identification Number)</font></td></tr></table><p><font style="font-size: 10pt;">&#160;</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="bottom"><td align="center" width="50%"><font style="font-size: 10pt;"><strong>4505 Emperor Blvd., Suite 200, Durham, North Carolina 27703</strong><!----></font></td></tr><tr valign="top"><td align="center" width="50%"><font style="font-size: 10pt;">(Address of Principal Executive Offices) (Zip Code)</font></td></tr></table><p align="center"><font style="font-size: 10pt;"><strong>(919) 859-1302</strong><br>(Registrant's telephone number, including area code)</font></p><p align="center"><font style="font-size: 10pt;"><strong></strong><br>(Former name or former address, if changed since last report)</font></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td colspan="3"><font style="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:<br><br></font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[ &#160; ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[ &#160; ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[ &#160; ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></td></tr><tr valign="top"><td width="21"><font style="font-size: 10pt;">&#160;</font></td><td width="40"><font style="font-size: 10pt;">[ &#160; ]</font></td><td nowrap="nowrap"><font style="font-size: 10pt;">&#160;&#160;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></td></tr></table><div style="margin-top: 12pt; margin-bottom: 3pt;"><div style="font-size: 1pt; border-top: Black 1.1pt solid; border-bottom: Black 2.5pt solid; width: 100%;"><font style="font-size: 10pt;">&#160;</font></div>&#160;</div><hr style="page-break-after: always;" noshade="noshade"><p><font style="font-size: 10pt;">  <strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 7.01. Regulation FD Disclosure.</strong></font></p><p><font style="font-size: 10pt;"><p>On January 30, 2017, BioCryst Pharmaceuticals, Inc. (&#8220;BioCryst&#8221;) announced that the European Medicines Agency (&#8220;EMA&#8221;) has accepted the filing of its peramivir Marketing Authorization Application (&#8220;MAA&#8221;) for treatment of symptoms typical of influenza in adults 18 years and older. Peramivir will be commercialized by Seqirus UK Limited as ALPIVAB<sup>TM</sup>.&#160; The acceptance of the MAA begins the review process by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland.</p><p>On January 30, 2017, the Company issued a news release announcing the events described in this Item 7.01.&#160; A copy of the news release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.</p><p>The information furnished in this Item 7.01 is not deemed &#8220;filed&#8221; for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.</p><p><strong><strong>Forward-Looking Statements</strong></strong></p><p>This Current Report on Form 8-K contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst&#8217;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the EMA may not provide regulatory approval for any use of peramivir or that the approval may be limited. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst&#8217;s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst&#8217;s projections and forward-looking statements.</p></font></p><p><font style="font-size: 10pt;"><strong>  </strong></font></p><p><font style="font-size: 10pt;"><strong>Item 9.01. Financial Statements and Exhibits.</strong></font></p><p><font style="font-size: 10pt;"><p><strong>(d) Exhibits</strong></p><table class="mce-item-table" width="100%"><tr><td><p><font style="font-size: 10pt;">99.1</font></p></td><td><p><font style="font-size: 10pt;">&#160;&#160;</font></p></td><td><p><font style="font-size: 10pt;">Press Release dated January 30, 2017 entitled &#8220;BioCryst Announces the Acceptance of Peramivir MAA filing by the European Medicines Agency&#8221;</font></p></td></tr></table></font></p><p><font style="font-size: 10pt;"></font></p><p><font style="font-size: 10pt;"></font></p><hr style="page-break-after: always;" noshade="noshade"><p align="center"><font style="font-size: 10pt;"><strong>SIGNATURE</strong></font></p><p><font style="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></p><table style="width: 100%;" border="0" cellspacing="0" cellpadding="0"><tr valign="top"><td valign="top" width="49%"><font style="font-size: 10pt;">&#160;</font></td><td style="font-size: 12pt;" colspan="2" valign="top"><font style="font-size: 10pt;"><strong>BioCryst Pharmaceuticals, Inc.</strong></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">Date: January 30, 2017</font></td><td width="2%"><font style="font-size: 10pt;">By:&#160;</font></td><td style="text-decoration: underline;" width="49%"><font style="font-size: 10pt;">/s/ Alane Barnes&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Alane Barnes</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;">Vice President, General Counsel,<br> and Corporate Secretary</font></td></tr><tr valign="top"><td width="49%"><font style="font-size: 10pt;">&#160;</font></td><td width="2%"><font style="font-size: 10pt;">&#160;</font></td><td width="49%"><font style="font-size: 10pt;"></font></td></tr></table><p><hr style="page-break-after: always;" noshade="noshade"><p style="text-align: center;"><font style="font-size: 10pt;"><strong>EXHIBIT INDEX</strong></font></p><p style="text-align: center;"><font style="font-size: 10pt;">&#160;</font></p><table style="font-size: 10pt;" border="0" cellspacing="0" cellpadding="0" class="mce-item-table"><tr><td style="text-decoration: underline;" valign="bottom"><font style="font-size: 10pt;"><strong>Exhibit No</strong></font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td style="text-decoration: underline;" valign="bottom"><font style="font-size: 10pt;"><strong>Description</strong></font></td></tr><tr><td><font style="font-size: 10pt;"></font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td><font style="font-size: 10pt;">&#160;</font></td></tr><tr><td><font style="font-size: 10pt;">99.1</font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td><font style="font-size: 10pt;">Press Release dated January 30, 2017 entitled &#8220;BioCryst Announces the Acceptance of Peramivir MAA filing by the European Medicines Agency&#8221;&#160;</font></td></tr></table><div id="mceResizeHandlen" class="mce-resizehandle" style="cursor: n-resize; margin: 0px; padding: 0px; left: 374.667px; top: 83.8333px;"></div><div id="mceResizeHandlee" class="mce-resizehandle" style="cursor: e-resize; margin: 0px; padding: 0px; left: 745.333px; top: 126.5px;"></div><div id="mceResizeHandles" class="mce-resizehandle" style="cursor: s-resize; margin: 0px; padding: 0px; left: 374.667px; top: 169.167px;"></div><div id="mceResizeHandlew" class="mce-resizehandle" style="cursor: w-resize; margin: 0px; padding: 0px; left: 4px; top: 126.5px;"></div><div id="mceResizeHandlenw" class="mce-resizehandle" style="cursor: nw-resize; margin: 0px; padding: 0px; left: 4px; top: 83.8333px;"></div><div id="mceResizeHandlene" class="mce-resizehandle" style="cursor: ne-resize; margin: 0px; padding: 0px; left: 745.333px; top: 83.8333px;"></div><div id="mceResizeHandlese" class="mce-resizehandle" style="cursor: se-resize; margin: 0px; padding: 0px; left: 745.333px; top: 169.167px;"></div><div id="mceResizeHandlesw" class="mce-resizehandle" style="cursor: sw-resize; margin: 0px; padding: 0px; left: 4px; top: 169.167px;"></div></p></body></html>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252"><meta name="GENERATOR" content="MSHTML 8.00.7601.18094"></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 99.1</strong></p><p style="text-align: center;"><strong>BioCryst Announces the Acceptance of Peramivir MAA Filing by the European Medicines Agency</strong></p><p style="text-align: center;"><p> <p align="justify">RESEARCH TRIANGLE PARK, N.C., Jan.  30, 2017  (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, announced today that the European Medicines Agency (EMA) has accepted the filing of its peramivir Marketing Authorization Application (MAA) for treatment of symptoms typical of influenza in adults 18&#160;years and older.&#160; The acceptance of the MAA begins the review process by the EMA under the centralized licensing procedure for all 28 member states of the European Union, Norway and Iceland. Peramivir&#8217;s efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.<br></p>  <p align="justify">&#8220;This filing brings BioCryst and Seqirus one step closer to making the only single-dose, I.V. influenza therapy available to an important market, the European Union,&#8221; said Jon P. Stonehouse, President &amp; Chief Executive Officer.&#160; &#160;&#160;</p>  <p align="justify">Seqirus, a leader in influenza prevention through the supply of seasonal and pandemic influenza vaccines to global markets, will commercialize ALPIVAB<sup>TM</sup>.</p>  <p align="justify"><strong>About Peramivir</strong></p>  <p align="justify">Peramivir is an intravenous (I.V.) viral neuraminidase inhibitor approved in multiple countries, including the United States, for the treatment of influenza in patients who have been symptomatic for no more than two days. Efficacy of peramivir is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled. The efficacy of peramivir could not be established in patients with serious influenza requiring hospitalization. In clinical studies, side effects with peramivir were similar to placebo. The most common adverse reaction was diarrhea (peramivir 8% vs 7% placebo). Similar to other neuraminidase inhibitors, there is a risk of neuropsychiatric events (confusion, delirium) and serious skin reactions. Visit www.rapivab.com to learn more.&#160; ALPIVAB is a trademark of Seqirus UK Limited.</p>  <p><strong>About BioCryst Pharmaceuticals </strong></p>  <p align="justify">BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases.&#160; BioCryst currently has several ongoing development programs: BCX7353 and second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. Peramivir, a viral neuraminidase inhibitor, is approved for the treatment of influenza, in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities are ongoing, as well as other activities to support additional peramivir regulatory approvals.&#160; For more information, please visit the Company's website at www.BioCryst.com.</p>  <p><strong>Forward-Looking Statements </strong></p>  <p align="justify">This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst&#8217;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the EMA may not provide regulatory approval for any use of peramivir or that the approval may be limited.&#160; Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst&#8217;s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst&#8217;s projections and forward-looking statements.</p>  <p>BCRXW</p>  <p> </p></p><p>CONTACT:<br>Robert Bennett, <br>BioCryst Pharmaceuticals, <br>+1-919-859-7910</p></body></html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
