<SEC-DOCUMENT>0001157523-15-004010.txt : 20151209
<SEC-HEADER>0001157523-15-004010.hdr.sgml : 20151209
<ACCEPTANCE-DATETIME>20151209161030
ACCESSION NUMBER:		0001157523-15-004010
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20151209
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20151209
DATE AS OF CHANGE:		20151209

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Anika Therapeutics, Inc.
		CENTRAL INDEX KEY:			0000898437
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				043145961
		STATE OF INCORPORATION:			MA
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-14027
		FILM NUMBER:		151278503

	BUSINESS ADDRESS:	
		STREET 1:		32 WIGGINS AVENUE
		CITY:			BEDFORD
		STATE:			MA
		ZIP:			01730
		BUSINESS PHONE:		(781) 457-9000

	MAIL ADDRESS:	
		STREET 1:		32 WIGGINS AVENUE
		CITY:			BEDFORD
		STATE:			MA
		ZIP:			01730

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ANIKA THERAPEUTICS INC
		DATE OF NAME CHANGE:	19970114

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ANIKA RESEARCH INC
		DATE OF NAME CHANGE:	19930309
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>a51240500.htm
<DESCRIPTION>ANIKA THERAPEUTICS, INC. 8-K
<TEXT>
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      <font style="font-size: 12pt; font-family: Times New Roman">UNITED STATES</font><font style="font-size: 12pt; font-family: Times New Roman"><br style="font-family: Times New Roman; font-size: 12pt"></font><font style="font-size: 12pt; font-family: Times New Roman">SECURITIES
      AND EXCHANGE COMMISSION</font><br><br><font style="font-size: 11pt">Washington,
      D.C. 20549</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 16pt; font-family: Times New Roman">FORM
      8-K</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt">CURRENT
      REPORT</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt">PURSUANT
      TO SECTION 13 OR 15(d)</font><br><font style="font-size: 11pt">OF THE
      SECURITIES EXCHANGE ACT OF 1934</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt; font-family: Times New Roman">Date
      of Report (Date of earliest event reported): December 9, 2015</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><font style="font-size: 12pt">Anika
      Therapeutics, Inc.</font><font style="font-size: 12pt"><br style="font-size: 12pt"></font><font style="font-size: 11pt">(</font><i><font style="font-size: 11pt">Exact
      name of registrant as specified in its charter</font></i><font style="font-size: 11pt">)</font>
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    <hr style="height: 1.0 pt; color: #000000; text-align: center; width: 40%">

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        <td style="width: 33%">

        </td>
        <td style="width: 34%">

        </td>
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          &#160;
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        <td valign="bottom" style="text-align: center; padding-left: 0.0px; width: 33%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Massachusetts
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        </td>
        <td valign="bottom" style="white-space: nowrap; text-align: center; padding-left: 0.0px; width: 34%; padding-right: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            000-21326
          </p>
        </td>
        <td valign="bottom" style="white-space: nowrap; text-align: center; padding-left: 0.0px; width: 33%; padding-right: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            04-314-5961
          </p>
        </td>
      </tr>
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        <td valign="top" style="text-align: center; padding-left: 0.0px; width: 33%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(State or other jurisdiction of</i><br><i>incorporation or
            organization)</i>
          </p>
        </td>
        <td valign="top" style="text-align: center; padding-left: 0.0px; width: 34%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>Commission file number</i>
          </p>
        </td>
        <td valign="top" style="text-align: center; padding-left: 0.0px; width: 33%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(I.R.S. Employer<br>Identification No.)</i>
          </p>
        </td>
      </tr>
    </table>
    </div>
    <p>

    </p>
    <div style="text-align:center">
    <table cellspacing="0" style="font-family: Times New Roman; margin-left:auto;margin-right:auto; font-size: 10pt; width: 100%; margin-bottom: 10.0px">
      <tr>
        <td valign="top" style="white-space: nowrap; text-align: center; padding-left: 0.0px; padding-right: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            32 Wiggins Avenue, Bedford, MA 01730
          </p>
        </td>
      </tr>
      <tr>
        <td valign="top" style="text-align: center; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(Address of principal executive offices) (Zip code)</i>
          </p>
        </td>
      </tr>
    </table>
    </div>
    <p style="white-space: nowrap; text-align: center">
      <br>
      <i><font style="font-size: 10pt; font-family: Times New Roman">Registrant&#8217;s
      telephone number, including area code:&#160;&#160;&#160;</font></i><font style="font-size: 10pt; font-family: Times New Roman">781-457-9000</font><br><br><br>
    </p>
    <p style="text-align: center">
      <i><font style="font-size: 10pt; font-family: Times New Roman">(Former
      name or former address, if changed since last report)</font></i><br>
    </p>
    <hr style="text-align: center; color: #000000; width: 40%; height: 1.0 pt">


    <p>

    </p>
    <p>
      <font style="font-size: 10pt; font-family: Times New Roman">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>
    </p>
    <p>
      <font style="font-size: 10pt; font-family: Arial Unicode MS">&#8414;</font>
      <font style="font-size: 10pt; font-family: Times New Roman">Written
      communications pursuant to Rule 425 under the Securities Act (17 CFR
      230.425)</font>
    </p>
    <p>
      <font style="font-size: 10pt; font-family: Arial Unicode MS">&#8414;</font>
      <font style="font-size: 10pt; font-family: Times New Roman">Soliciting
      material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
      240.14a-12)</font>
    </p>
    <p>
      <font style="font-size: 10pt; font-family: Arial Unicode MS">&#8414;</font>
      <font style="font-size: 10pt; 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>
    <p>
      <font style="font-size: 10pt; font-family: Arial Unicode MS">&#8414;</font>
      <font style="font-size: 10pt; 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><br><br>
    </p>
    <div style="margin-right: 0pt; margin-left: 0pt; text-indent: 0pt; width: 100%; margin-bottom: 10pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
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        <div style="text-align: center">

        </div>
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          <hr style="color: black; height: 1.5pt">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p>

    </p>
    <p style="text-align: center">
      <b>Section 8&#8212;Other Events</b>
    </p>
    <p>

    </p>
    <p style="white-space: nowrap">
      Item 8.01.&#160;&#160;Other Events.
    </p>
    <p>

    </p>
    <p>
      On December 9, 2015, Anika Therapeutics, Inc. issued a press release to
      announce that the U.S. Food and Drug Administration&#8217;s Office of
      Combination Products has assigned the company&#8217;s CINGAL product to the
      Center for Drug Evaluation and Research as the lead center for premarket
      review of the product.&#160;&#160;The full text of the press release is furnished
      as Exhibit 99.1 hereto.
    </p>
    <p>
      The exhibit attached hereto is intended to be furnished and shall not be
      deemed &quot;filed&quot; for purposes of Section 18 of the Securities Exchange Act
      of 1934 (the &quot;Exchange Act&quot;) or otherwise subject to the liabilities of
      that section, nor shall it be deemed incorporated by reference in any
      filing under the Securities Act of 1933 or the Exchange Act, except as
      expressly set forth by specific reference in such filing.
    </p>
    <p>

    </p>
    <p>

    </p>
    <p style="text-align: center">
      <b>Section 9--Financial Statements and Exhibits</b>
    </p>
    <p>

    </p>
    <p style="white-space: nowrap">
      Item 9.01.&#160;&#160;Financial Statements and Exhibits.
    </p>
    <p style="white-space: nowrap">

    </p>
    <p style="white-space: nowrap">
      (d)&#160;&#160;Exhibits.
    </p>
    <p>

    </p>
    <p style="white-space: nowrap">
      99.1&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;Press Release of Anika Therapeutics, Inc. dated December
      9, 2015.
    </p>
    <p style="margin-left: 60.0px">

    </p>
    <p>

    </p>
    <p>

    </p>
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      </div>
    </div>
    <p>

    </p>
    <p style="text-align: center">
      <font style="font-size: 10pt; font-family: Times New Roman">SIGNATURE</font><br>
    </p>
    <p>
      Pursuant to the requirements of the Securities Exchange Act of 1934, the
      registrant has duly caused this report to be filed on its behalf by the
      undersigned hereunto duly authorized.
    </p>
    <p>

    </p>
    <div style="text-align:center">
    <table cellspacing="0" style="font-family: Times New Roman; margin-left:auto;margin-right:auto; font-size: 10pt; width: 100%; margin-bottom: 10.0px">
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        </td>
        <td valign="top" colspan="3" style="text-align: left; padding-left: 0.0px">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Anika Therapeutics, Inc.
          </p>
        </td>
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        </td>
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          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
        <td style="width: 37%">

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        <td style="width: 10%">

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      </tr>
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          <p style="margin-top: 0px; margin-bottom: 0px">
            Dated: December 9, 2015
          </p>
        </td>
        <td valign="top" style="text-align: left; padding-bottom: 2.0px; padding-left: 0.0px; width: 3%">
          By:
        </td>
        <td valign="top" style="border-bottom-color: black; border-bottom-width: 1.0pt; text-align: left; padding-left: 25.0px; width: 37%; border-bottom-style: solid">
          <p style="margin-top: 0px; margin-bottom: 0px">
            /s/ Sylvia Cheung
          </p>
        </td>
        <td style="width: 10%">

        </td>
      </tr>
      <tr>
        <td style="width: 50%">

        </td>
        <td valign="top" style="text-align: left; padding-left: 0.0px; width: 3%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
        <td valign="top" style="text-align: left; padding-left: 25.0px; width: 37%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Sylvia Cheung
          </p>
        </td>
        <td style="width: 10%">

        </td>
      </tr>
      <tr>
        <td style="width: 50%">

        </td>
        <td valign="top" style="text-align: left; padding-left: 0.0px; width: 3%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            &#160;
          </p>
        </td>
        <td valign="top" style="text-align: left; padding-left: 25.0px; width: 37%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Chief Financial Officer
          </p>
        </td>
        <td style="width: 10%">

        </td>
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        <div style="text-align: left">

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          <hr style="color: black; height: 1.5pt">

        </div>
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        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p>

    </p>
    <p style="text-align: center">
      <font style="font-size: 11pt">Exhibit Index</font><font style="font-size: 11pt"><br style="font-size: 11pt"></font><br>
    </p>
<div style="text-align:left">
    <table cellspacing="0" style="font-family: Times New Roman; font-size: 10pt; width: 100%; margin-bottom: 10.0px">
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          99.1
        </td>
        <td valign="top" style="text-align: left; padding-left: 0.0px; width: 2%">
          &#160;
        </td>
        <td valign="top" style="text-align: left; padding-left: 0.0px; width: 88%">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Press Release of Anika Therapeutics, Inc. dated December 9, 2015.
          </p>
        </td>
      </tr>
    </table>
    </div>
    <p>

    </p>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a51240500ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <p style="text-align: right">
      <b>Exhibit 99.1</b>
    </p>
    <p style="text-align: center">
      <font style="font-size: 12pt; font-family: Times New Roman"><b>Anika
      Therapeutics Announces Decision to Proceed with CINGAL&#174; Premarket Review
      Through FDA&#8217;s Center for Drug Evaluation and Research</b></font>
    </p>
    <p>
      BEDFORD, Mass.--(BUSINESS WIRE)--December 9, 2015--Anika Therapeutics,
      Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company
      specializing in therapeutics based on its proprietary hyaluronic acid
      technology, today announced that the U.S. Food &amp; Drug Administration&#8217;s
      (FDA) Office of Combination Products has assigned CINGAL&#174; to the Center
      for Drug Evaluation and Research (CDER) as the lead center for premarket
      review.
    </p>
    <p>
      CINGAL is the first combination viscosupplement formulated with Anika&#8217;s
      proprietary cross-linked sodium hyaluronate (currently marketed as the
      single-injection viscosupplement MONOVISC&#174;) and triamcinolone
      hexacetonide, an FDA-approved steroid to treat inflammation. Earlier
      this year, Anika announced positive results from its CINGAL 13-01 and
      13-02 studies, demonstrating the efficacy and safety of a single
      injection of CINGAL for treatment of pain caused by osteoarthritis (OA)
      of the knee, as well as the safety of a repeat injection.
    </p>
    <p>
      &#8220;While we strongly disagree with the FDA&#8217;s decision, as our position of
      CINGAL&#8217;s device-lead classification is supported by both regulations and
      scientific data, we intend to proceed expeditiously to move CINGAL
      through regulatory review,&#8221; said Dr. Charles H. Sherwood, President and
      Chief Executive Officer of Anika Therapeutics. &#8220;We have already been in
      contact with CDER to start the NDA process, and are confident that the
      definitive results from two clinical studies provide the essential
      foundation for marketing approval of CINGAL.&#8221;
    </p>
    <p>
      CINGAL is Anika Therapeutics&#8217; third-generation viscosupplementation
      product, adding to the Company&#8217;s strong product portfolio for the
      treatment of joint pain associated with OA. Anika already maintains a
      market leadership position in the United States and a growing presence
      internationally, with its multi-injection product, ORTHOVISC&#174;, and its
      single-injection product, MONOVISC. CINGAL was approved in Canada as a
      medical device to treat pain associated with OA of the knee, and is
      under review in the E.U.
    </p>
    <p>
      <b>About Anika Therapeutics, Inc.</b><br>Anika Therapeutics, Inc.
      (NASDAQ: ANIK) is a global, integrated orthopedics medicines company
      based in Bedford, Mass. Anika is committed to improving the lives of
      patients with degenerative orthopedic diseases and traumatic conditions
      by providing clinically meaningful therapeutic pain management solutions
      along the continuum of care, from palliative care to regenerative
      medicine. The Company has over two decades of expertise developing,
      manufacturing and commercializing more than 20 products, in markets
      across the globe, based on its proprietary hyaluronic acid (HA)
      technology. Anika&#8217;s orthopedic medicine portfolio is comprised of
      marketed (ORTHOVISC&#174; and MONOVISC&#174;) and pipeline (CINGAL&#174; and HYALOFAST&#174;
      in the U.S.) products to alleviate pain and restore joint function by
      replenishing depleted HA and aiding cartilage repair and regeneration.
      For more information about Anika, please visit <u>http://www.anikatherapeutics.com</u>.
    </p>
    <div style="margin-left: 0pt; margin-right: 0pt; text-indent: 0pt; width: 100%; margin-bottom: 10pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
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        <div style="text-align: center">

        </div>
        <div style="text-align: center">
          <hr style="color: black; height: 1.5pt">

        </div>
      </div>
      <div>
        <div style="text-align: right">

        </div>
      </div>
    </div>
    <p>
      <b>Forward-Looking Statements</b>
    </p>
    <p>
      <i>The statements made in the third and fourth paragraphs of this press
      release, which are not statements of historical fact, are
      forward-looking statements within the meaning of Section 27A of the
      Securities Act of 1933, as amended, and Section 21E of the Securities
      Exchange Act of 1934, as amended. These statements include, but are not
      limited to, those relating to the U.S. and global regulatory progress of
      CINGAL and the Company&#8217;s leadership position in the viscosupplementation
      market. These statements are based upon the current beliefs and
      expectations of the Company&#8217;s management and are subject to significant
      risks, uncertainties, and other factors. The Company&#8217;s actual results
      could differ materially from any anticipated future results,
      performance, or achievements described in the forward-looking statements
      as a result of a number of factors including (i) the Company&#8217;s ability
      to successfully commence and/or complete clinical trials of its
      products, including for HYALOFAST or for expanded indications of the
      Company&#8217;s MONOVISC product, on a timely basis or at all; (ii) the
      Company&#8217;s ability to obtain pre-clinical or clinical data to support
      domestic and international pre-market approval applications or 510(k)
      applications, or to timely file and receive FDA or other regulatory
      approvals or clearances of its products; (iii) that such approvals,
      including for CINGAL, will not be obtained in a timely manner or without
      the need for additional clinical trials, other testing or regulatory
      submissions, as applicable; (iv) the Company&#8217;s research and product
      development efforts and their relative success, including whether we
      have any meaningful sales of any new products resulting from such
      efforts; (v) the cost effectiveness and efficiency of the Company&#8217;s
      clinical studies, manufacturing operations, and production planning;
      (vi) the strength of the economies in which the Company operate or will
      be operating, as well as the political stability of any of those
      geographic areas; (vii) future determinations by the Company to allocate
      resources to products and in directions not presently contemplated;
      (viii) the Company&#8217;s ability to successfully commercialize its products,
      in the U.S. and abroad; (ix) the Company&#8217;s ability to provide an
      adequate and timely supply of its products to its customers; (x) the
      Company&#8217;s ability to continue to successfully manage Anika Therapeutics
      S.r.l.&#8217;s business; and (xi) the Company&#8217;s ability to achieve its growth
      targets.</i>
    </p>
    <p>

    </p>
    <p>
      CONTACT:<br>Anika Therapeutics, Inc.<br>Christopher Ranjitkar,
      781-457-9000<br>IR &amp; Corporate Communications Manager
    </p>
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