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<p style="text-align:center;line-height:4pt;border-bottom:Double 2.25pt;padding-bottom:1pt;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:4pt;">&nbsp;</p>
<p style="text-align:center;margin-top:4pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNITED STATES</p>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:18pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FORM 8-K</p>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">CURRENT REPORT</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">of The Securities Exchange Act of 1934</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:12pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Date of Report (Date of earliest event reported): <font style="text-decoration:underline;">December 14, 2015</font></p>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-size:24pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">ANTARES PHARMA, INC.</p>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(I.R.S. Employer</p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">100 Princeton South, Suite 300, Ewing, NJ</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">08628</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Address of principal executive offices)</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;font-size:8pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">(Zip Code)</p></td>
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<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Registrant&#8217;s telephone, including area code: <font style="text-decoration:underline;">(609) 359-3020</font></p>
<p style="text-align:center;margin-top:2pt;border-bottom:Solid 0.75pt;padding-bottom:1pt;margin-bottom:0pt;margin-left:40%;margin-right:40%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 (<font style="font-style:italic;">see</font> General Instruction A.2. below):</p>
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<p style="margin-top:6pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></p></td></tr></table></div>
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<p style="margin-top:6pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></p></td></tr></table></div>
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<p style="margin-top:6pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></p></td></tr></table></div>
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<p style="margin-top:6pt;margin-bottom:0pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;font-size:10pt;"><font style="font-family:Times New Roman;">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></p></td></tr></table></div>
<p style="margin-top:12pt;line-height:4pt;border-bottom:Double 2.25pt;padding-bottom:1pt;margin-bottom:0pt;text-indent:0%;font-size:4pt;">&nbsp;</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU2"></a><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item 7.01.</font><font style="margin-left:36pt;"></font><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">R</font><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">egulation FD Disclosure. </font></p>
<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On December 14, 2015, the Company issued a press release announcing that the FDA has approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established.&nbsp;&nbsp;A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 7.01.</p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The information contained in Item 7.01, Item 9.01 and Exhibit 99.1 of this Form 8-K are being &#8220;furnished&#8221; to the Securities and Exchange Commission and shall not be incorporated by reference into any filings of the Company under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended (regardless of any general incorporation language in such filing) unless expressly incorporated into such filing by specific reference to the &#8220;furnished&#8221; information contained herein.</p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item 8.01.<font style="margin-left:36pt;"></font>Other Events.</p>
<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In December 2015, the FDA approved the Company&#8217;s ANDA for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established.</p>
<p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Item 9.01&#160;<font style="margin-left:36pt;">Financial Statements and Exhibits</font></p>
<p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">(d) Exhibits. </p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Description</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Press Release, dated December 14, 2015, issued by Antares Pharma, Inc.</p></td>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><a name="_AEIOULastRenderedPageBreakAEIOU3"></a><font style="font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">SIGNATURES</font></p>
<p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p>
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atrs-8k_20151214.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
December 14, 2015
ANTARES PHARMA, INC.
(Exact name of registrant specified in its charter)
Delaware
1-32302
41-1350192
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
100 Princeton South, Suite 300, Ewing, NJ
08628
(Address of principal executive offices)
(Zip Code)
Registrant's telephone, including area code:
(609) 359-3020
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):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01.
R
egulation FD Disclosure.
On December 14, 2015, the Company issued a press release announcing that the FDA has approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established.  A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 7.01.
The information contained in Item 7.01, Item 9.01 and Exhibit 99.1 of this Form 8-K are being "furnished" to the Securities and Exchange Commission and shall not be incorporated by reference into any filings of the Company under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended (regardless of any general incorporation language in such filing) unless expressly incorporated into such filing by specific reference to the "furnished" information contained herein.
Item 8.01.
Other Events.
In December 2015, the FDA approved the Company's ANDA for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established.
Item 9.01
Financial Statements and Exhibits
(d) Exhibits.
Exhibit No.
Description
99.1
Press Release, dated December 14, 2015, issued by Antares Pharma, Inc.
SIGNATURES
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.
ANTARES PHARMA, INC.
Date:
December 18, 2015
By:
/s/ Peter Graham
Name:
Peter Graham
Title:
Senior Vice President, General Counsel
Chief Compliance Officer, Human Resources and Secretary