<SEC-DOCUMENT>0001104659-17-009494.txt : 20170215
<SEC-HEADER>0001104659-17-009494.hdr.sgml : 20170215
<ACCEPTANCE-DATETIME>20170215075126
ACCESSION NUMBER:		0001104659-17-009494
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20170215
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170215
DATE AS OF CHANGE:		20170215

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			AMICUS THERAPEUTICS INC
		CENTRAL INDEX KEY:			0001178879
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				200422823
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33497
		FILM NUMBER:		17612930

	BUSINESS ADDRESS:	
		STREET 1:		1 CEDAR BROOK DRIVE
		CITY:			CRANBURY
		STATE:			NJ
		ZIP:			08512
		BUSINESS PHONE:		(609) 662-2000

	MAIL ADDRESS:	
		STREET 1:		1 CEDAR BROOK DRIVE
		CITY:			CRANBURY
		STATE:			NJ
		ZIP:			08512
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>a17-4515_28k.htm
<DESCRIPTION>8-K
<TEXT>


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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">UNITED STATES<br> SECURITIES AND EXCHANGE COMMISSION</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Washington, D.C. 20549</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">FORM&nbsp;8-K</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">CURRENT REPORT<br> Pursuant to Section&nbsp;13 or 15(d)&nbsp;of the Securities Exchange Act of 1934</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Date of Report (Date of earliest event reported): <b>February&nbsp;15, 2017</b></font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">AMICUS THERAPEUTICS,&nbsp;INC.</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(Exact name of registrant as specified in its charter)</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">001-33497</font></b></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">71-0869350</font></b></p>    </td>   </tr>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(IRS Employer   Identification No.)</font></p>    </td>   </tr>  </table>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">1 Cedar   Brook Drive, Cranbury, NJ</font></b></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">08512</font></b></p>    </td>   </tr>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Registrant&#146;s telephone number, including area code: <b>(609) 662-2000</b></font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(Former name or former address if changed since last report.)</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Check the appropriate box below if the Form&nbsp;8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font> Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</p>
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<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font> Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</p>
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<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font> Pre-commencement communications pursuant to Rule&nbsp;14d-2(b)&nbsp;under the Exchange Act (17 CFR 240.14d-2(b))</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font> Pre-commencement communications pursuant to Rule&nbsp;13e-4(c)&nbsp;under the Exchange Act (17 CFR 240.13e-4(c))</p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Item 8.01. Other Events.</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;text-indent:.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">On February&nbsp;15, 2017, Amicus Therapeutics,&nbsp;Inc. (the &#147;Company&#148;) issued a press release highlighting preclinical data for the Company&#146;s Pompe Program at the WORLDSymposium&#153; 2017 conference in San Diego, California. A copy of this press release is attached hereto as Exhibit&nbsp;99.1.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Item 9.01. Financial Statements and Exhibits.</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(d)&nbsp;Exhibits:&nbsp; The Exhibit&nbsp;Index annexed hereto is incorporated herein by reference.</font></p>
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<p style="margin:0in 0in .0001pt;"><b><font size="1" face="Times New Roman" style="font-size:8.0pt;font-weight:bold;">Exhibit<br>   No.</font></b></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="1" face="Times New Roman" style="font-size:1.0pt;font-weight:bold;">&nbsp;</font></b></p>    </td>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="1" face="Times New Roman" style="font-size:8.0pt;font-weight:bold;">Description</font></b></p>    </td>   </tr>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">99.1</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Press Release dated   February&nbsp;15, 2017 titled &#147;Amicus Therapeutics Presents Important New   Scientific Findings and Preclinical Data for Pompe Program at WORLDSymposium&#153;   2017.&#148;</font></p>    </td>   </tr>  </table>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="font-size:10.0pt;margin:0in 0in .0001pt;text-align:center;">2<a name="PB_2_070456_5454"></a></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">SIGNATURES</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;text-indent:.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">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>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">AMICUS   THERAPEUTICS,&nbsp;INC.</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt 10.0pt;text-indent:-10.0pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt 10.0pt;text-indent:-10.0pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Date:   February&nbsp;15, 2017</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">By:</font></p>    </td>
<td width="43%" valign="top" style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 0in 0in;width:43.34%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">/s/ ELLEN S. ROSENBERG</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt 10.0pt;text-indent:-10.0pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="6%" valign="top" style="padding:0in 0in 0in 0in;width:6.66%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Name:</font></p>    </td>
<td width="43%" valign="top" style="padding:0in 0in 0in 0in;width:43.34%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Ellen S. Rosenberg</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt 10.0pt;text-indent:-10.0pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Title:</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">General Counsel and   Corporate Secretary</font></p>    </td>   </tr>  </table>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="font-size:10.0pt;margin:0in 0in .0001pt;text-align:center;">3<a name="PB_3_070629_7056"></a></p>
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<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a17-4515_2ex99d1.htm
<DESCRIPTION>EX-99.1
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<p align="right" style="margin:0in 0in .0001pt;text-align:right;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Exhibit 99.1</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman"><img width="181" height="68" src="g45152mmi001.jpg"></font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Amicus Therapeutics Presents Important New Scientific Findings and Preclinical Data for Pompe Program at WORLD<i>Symposium&#153;</i> 2017</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><i><font size="2" face="Times New Roman" style="font-size:10.0pt;font-style:italic;font-weight:bold;">Scientific Findings Reveal that Cellular Damage Alters Trafficking for Key Proteins Involved in Muscle Membrane Integrity and Muscle Repair</font></i></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><i><font size="2" face="Times New Roman" style="font-size:10.0pt;font-style:italic;font-weight:bold;">Preclinical Studies Demonstrate Reversal of Cellular Damage and Significant Improvements in Muscle Strength in GAA Knock-out Mice After Treatment with Amicus Novel Pompe Treatment Paradigm</font></i></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><i><font size="2" face="Times New Roman" style="font-size:10.0pt;font-style:italic;font-weight:bold;">Additional Phase 1/2 Clinical Data to be Presented at Wednesday Afternoon Poster Session (4:30pm PT)</font></i></b></p>
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<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">CRANBURY, NJ, and SAN DIEGO, CA, February&nbsp;15, 2017</font></b> &#151; Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company at the forefront of rare and orphan diseases, today presented new scientific findings and preclinical data on functional outcomes in an oral presentation and poster(1) at the 13<font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">th</font>&#160;Annual WORLD<i>Symposium&#153;</i> in San Diego, CA.&#160; ATB200/AT2221 is a novel treatment paradigm that consists of ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose-6 phosphate (M6P), to enhance uptake in muscles, co-administered with AT2221, a pharmacological chaperone designed to stabilize ERT in circulation.</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">In previously reported preclinical studies, ATB200 was associated with increased tissue enzyme levels and reduced glycogen levels in muscle, which was further improved when AT2221 was co-administered with ATB200. For the first time at WORLD<i>Symposium</i>, Hung Do, PhD, Chief Science Officer of Amicus Therapeutics, presented results from preclinical studies that showed ATB200/AT2221 reversed cellular dysfunction and progressively increased muscle strength following every-other-week administration at 20 mg/kg over a five month period in an animal model of Pompe disease (GAA knock-out mice).</font></p>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Key Scientific Findings</font></b></p>
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<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>Impaired autophagy and other cellular defects lead to accumulation of intracellular vesicles that hinders protein trafficking for many proteins including key proteins that are required for muscle membrane integrity (various members of dystrophin-associated protein complex) and muscle repair (dysferlin) in muscles of <i>Gaa</i> knock-out mouse model of Pompe disease</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>Membrane and protein mistrafficking appeared to alter muscle structure which likely contributes towards progressive muscle weakness and persistent disrepair</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>Protein mistrafficking of these key proteins also observed in Pompe patient muscle biopsies</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Key Highlights on New Preclinical Data for ATB200/AT2221 in GAA Knock-Out Mice</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>ATB200/AT2221 is well-targeted to lysosomes of muscles which led to significant clearance of accumulated glycogen substrate in muscles of <i>Gaa</i> knock-out mice</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>ATB200/AT2221 also appeared to restore important cellular pathways and muscle structure that were significantly altered</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>ATB200/AT2221 continuously improved functional muscle strength over 5-month study period (as measured by wire hang and grip strength tests)</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font>Collectively, the data suggest that improved targeting and stabilization of ATB200 resulted in superior glycogen clearance, as well as continual reversal of muscle damage leading to improved muscle function</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Dr.&nbsp;Do stated, &#147;Our latest preclinical studies give us further confidence that ATB200/AT2221 has been optimally designed for efficient targeting to muscles. The results build upon our prior preclinical studies showing that ATB200/AT2221 not </font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">only clears accumulated glycogen but importantly, significantly reversed muscle damage and increased muscle function. These studies have also been invaluable for gaining important insights into the role of protein mistrafficking as contributing factors towards muscle weakness and disrepair in Pompe disease, and the potential for ATB200/AT2221 to reverse cellular dysfunction to restore muscle structure and increase muscle strength.&#148;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Grace K. Pavlath, Ph.D., Senior Vice President, Scientific Program Director of the Muscular Dystrophy Associated stated, &#147;The scientific findings and preclinical data presented today are profound and shed new light on questions about the underlying cause of muscle damage and weakness in Pompe patients.&#160; Furthermore, these results provide a window into a potential underlying link among key muscular dystrophies, such as Pompe, Limb Girdle, and Duchenne. Amicus has been a pioneer in advancing the scientific understanding of Pompe disease and in developing next-generation therapies for patients.&#148;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><u><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About ATB200/AT2221</font></u></b></p>
<p style="font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">ATB200/AT2221 is a novel treatment paradigm that consists of </font>ATB200, a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures, particularly mannose 6-phosphate (M6P), to enhance uptake, co-administered with AT2221, a pharmacological chaperone. In preclinical studies, ATB200 was associated with increased tissue enzyme levels and reduced glycogen levels in muscle, which was further improved when AT2221 was co-administered with ATB200. Amicus Therapeutics is currently conducting a global Phase 1/2 study (ATB200-02) to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of ATB200/AT2221.</p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><u><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About Pompe Disease</font></u></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Pompe disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to the accumulation of the substrate glycogen in the lysosomes of muscles and other tissues. Progressive accumulation of glycogen is believed to lead to the morbidity and mortality associated with Pompe disease, including muscle weakness and respiratory insufficiency.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><b><u><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;font-weight:bold;">About Amicus Therapeutics</font></u></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;font-size:10.0pt;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman"><font style="border:none;font-size:10.0pt;">Amicus Therapeutics</font><font style="border:none;"> (Nasdaq: FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus&#146; lead programs in development include the small molecule pharmacological chaperone </font></font><font style="border:none;">migalastat</font><font style="border:none;"> as a monotherapy for Fabry disease, </font><font style="border:none;">SD-101</font><font style="border:none;"> for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<div style="margin:0in 0in .0001pt;"><hr size="1" width="25%" noshade align="left" style="color:black;"></div>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">(1)Do, <i>et. al,</i>  <b>WORLD<i>Symposium</i> 2017</b>, ATB200/AT2221 Cleared Accumulated Glycogen and Reversed Cellular Dysfunction to Increase Functional Muscle Strength in Mouse Model of Pompe Disease</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><b><u><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;font-weight:bold;">Forward-Looking Statements</font></u></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">This press release contains &#147;forward- looking statements&#148; within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to encouraging pre-clinical data from a study to investigate ATB200/AT2221 in a knock-out mouse model and the potential implications on these data for the future advancement and development of ATB200/AT2221 in humans.&#160; Words such as, but not limited to, &#147;look forward to,&#148; &#147;believe,&#148; &#147;expect,&#148; &#147;anticipate,&#148; &#147;estimate,&#148; &#147;intend,&#148; &#147;confidence,&#148; &#147;encouraged,&#148; &#147;potential,&#148; &#147;plan,&#148; &#147;targets,&#148; &#147;likely,&#148; &#147;may,&#148; &#147;will,&#148; &#147;would,&#148; &#147;should&#148; and &#147;could,&#148; and similar expressions or words identify forward-looking statements.&#160; The forward looking statements included in this press release are based on management&#146;s current expectations and belief&#146;s which are subject to a number of risks, uncertainties and factors,&#160; including that the pre-clinical data will not be predictive of future results in humans, and that preliminary human clinical data based on a small patient sample and reported before completion of the study&#160; will not&#160; be predictive of future results,&#160; that results of additional preliminary data or data from&#160; the completed study or any future study will not yield results that are consistent with the pre-clinical or preliminary data presented, that the Company will be not&#160; able to demonstrate the safety and efficacy of ATB200/AT2221, that later&#160; study results will not support&#160; further development, or even if such later&#160; results are favorable, that the Company will not be able to&#160; successfully complete the development of, obtain regulatory approval for, or successfully commercialize&#160; ATB200/AT2221.&#160; In addition, all forward looking statements are subject to the other risks and uncertainties detailed in our Annual Report on Form&nbsp;10-K for the year ended December&nbsp;31, 2015 and Quarterly Report on 10-Q for the Quarter ended September&nbsp;30, 2016.&#160; As a consequence, actual results may differ materially from those set forth in this press release or the accompanying conference call or webcast.&#160; You are cautioned not to place undue reliance on these forward looking statements, which speak only of the date hereof.&#160; All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise this press release to reflect events or circumstances after the date hereof.</font></p>
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<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">CONTACTS:</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;font-weight:bold;">Investors/Media:</font></b></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">Amicus Therapeutics</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">Sara Pellegrino</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">Senior Director,&nbsp;Investor Relations</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">spellegrino@amicusrx.com</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">(609) 662-5044</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;font-weight:bold;">Media:</font></b></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">MWW PR</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">Sid Dinsay</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">sdinsay@mww.com</font></p>
<p style="border:none;margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="border:none;font-size:10.0pt;">(646) 381-9017</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">FOLD&#151;G</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
