<SEC-DOCUMENT>0001157523-18-001308.txt : 20180619
<SEC-HEADER>0001157523-18-001308.hdr.sgml : 20180619
<ACCEPTANCE-DATETIME>20180619160520
ACCESSION NUMBER:		0001157523-18-001308
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180619
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20180619
DATE AS OF CHANGE:		20180619

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:		18907178

	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>a51824698.htm
<DESCRIPTION>ANIKA THERAPEUTICS, INC. 8-K
<TEXT>
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      <font style="font-family: Times New Roman; font-size: 16pt">UNITED STATES</font><font style="font-family: Times New Roman; font-size: 16pt"><br style="font-family: Times New Roman; font-size: 16pt"></font><font style="font-family: Times New Roman; font-size: 16pt">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-family: Times New Roman; font-size: 16pt">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-family: Times New Roman; font-size: 11pt">Date
      of Report (Date of earliest event reported): June 19, 2018</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">Anika
      Therapeutics, Inc.</font><font style="font-size: 11pt"><br style="font-size: 11pt"></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>
    </p>
    <hr style="height: 1.0 pt; width: 15%; text-align: center; color: #000000">

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            Massachusetts
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          <p style="margin-top: 0px; margin-bottom: 0px">
            000-21326
          </p>
        </td>
        <td style="white-space: nowrap; width: 33%; text-align: center; padding-right: 0.0px; padding-left: 0.0px" valign="bottom">
          <p style="margin-top: 0px; margin-bottom: 0px">
            04-3145961
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          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(State or other jurisdiction of</i><br><i>incorporation or
            organization)</i>
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        </td>
        <td style="width: 34%; text-align: center; padding-left: 0.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>Commission file number</i>
          </p>
        </td>
        <td style="width: 33%; text-align: center; padding-left: 0.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(I.R.S. Employer<br>Identification No.)</i>
          </p>
        </td>
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    </div>
    <p>

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        <td style="white-space: nowrap; text-align: center; padding-right: 0.0px; padding-left: 0.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            32 Wiggins Avenue, Bedford, MA 01730
          </p>
        </td>
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        <td style="text-align: center; padding-left: 0.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <i>(Address of principal executive offices) (Zip code)</i>
          </p>
        </td>
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    </table>
    </div>
    <p style="white-space: nowrap; text-align: center">
      <br>
      (<font style="font-family: Times New Roman; font-size: 10pt">781)-457-9000</font><br><i><font style="font-family: Times New Roman; font-size: 10pt">Registrant&#8217;s
      telephone number, including area code:&#160;&#160;&#160;</font></i><br><br>
    </p>
    <p style="text-align: center">
      Not Applicable<br><i><font style="font-family: Times New Roman; font-size: 10pt">(Former
      name or former address, if changed since last report)</font></i><br>
    </p>
    <hr style="height: 1.0 pt; width: 15%; text-align: center; color: #000000">


    <p>

    </p>
    <p>
      <font style="font-family: Times New Roman; 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:</font><br><br><font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Written
      communications pursuant to Rule 425 under the Securities Act (17 CFR
      230.425)</font><br><font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Soliciting
      material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
      240.14a-12)</font><br><font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Pre-commencement
      communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
      240.14d-2(b))</font><br><font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
      <font style="font-family: Times New Roman; font-size: 10pt">Pre-commencement
      communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
      240.13e-4(c))</font><br>
    </p>
    <p>
      Indicate by check mark whether the registrant is an emerging growth
      company as defined in Rule 405 of the Securities Act of 1933 (17 CFR
      &#167;230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR
      &#167;240.12b-2).<br>Emerging growth company&#160;&#160;&#160;<font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
    </p>
    <p>
      If an emerging growth company, indicate by check mark if the registrant
      has elected not to use the extended transition period for complying with
      any new or revised financial accounting standards provided pursuant to
      Section 13(a) of the Exchange Act.&#160;&#160;&#160;<font style="font-family: Arial Unicode MS; font-size: 10pt">&#8414;</font>
    </p>
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    <p style="white-space: nowrap">
      <b>Item 8.01.&#160;&#160;&#160;&#160;&#160;Other Events.</b>
    </p>
    <p>
      On June 19, 2018, Anika Therapeutics, Inc. issued a press release to
      announce certain top-line results from its Cingal 16-02 Clinical Trial.
      The full text of the press release is filed as Exhibit 99.1 hereto, and
      is hereby incorporated by reference into this Item 8.01.
    </p>
    <p style="white-space: nowrap">
      <b>Item 9.01.&#160;&#160;&#160;&#160;&#160;Financial Statements and Exhibits.</b>
    </p>
    <p style="white-space: nowrap">
      (d)&#160;&#160;&#160;&#160;&#160;&#160;&#160;Exhibits.
    </p>
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          <b>Exhibit No.</b>
        </td>
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          &#160;
        </td>
        <td style="border-bottom-style: solid; width: 88%; text-align: center; border-bottom-color: black; border-bottom-width: 1.0pt; padding-left: 0.0px" valign="bottom">
          <b>Description</b>
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          <p style="margin-top: 0px; margin-bottom: 0px">
            <a href="a51824698ex99_1.htm">99.1</a>
          </p>
        </td>
        <td style="width: 2%">

        </td>
        <td style="width: 88%; text-align: left; padding-left: 0.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            <a href="a51824698ex99_1.htm">Press Release of Anika Therapeutics,
            Inc. dated June 19, 2018.</a>
          </p>
        </td>
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    </div>
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    </p>
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    <p>

    </p>
    <p style="text-align: center">
      <font style="font-family: Times New Roman; font-size: 10pt">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.<br><br><br>
    </p>
    <div style="text-align:center">
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          <p style="margin-top: 0px; margin-bottom: 0px">
            Anika Therapeutics, Inc.
          </p>
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            &#160;
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        <td style="width: 37%">

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        <td style="width: 37%">

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          &#160;
        </td>
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          <p style="margin-top: 0px; margin-bottom: 0px">
            Dated: June 19, 2018
          </p>
        </td>
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          By:
        </td>
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          <p style="margin-top: 0px; margin-bottom: 0px">
            /s/ Sylvia Cheung
          </p>
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            &#160;
          </p>
        </td>
        <td style="width: 37%; text-align: left; padding-left: 25.0px" valign="top">
          <p style="margin-top: 0px; margin-bottom: 0px">
            Sylvia Cheung
          </p>
        </td>
        <td style="width: 10%">

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

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a51824698ex99_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-family: Times New Roman; font-size: 12pt"><b>Anika
      Therapeutics Announces Top-Line Results from CINGAL 16-02 Clinical Trial
      in Knee Osteoarthritis</b></font>
    </p>
    <p style="text-align: center">
      <i><font style="font-family: Times New Roman; font-size: 12pt"><b>CINGAL
      16-02 study did not achieve statistical significance at primary endpoint
      of 26 weeks in active comparator study; Company committed to working
      closely with regulators to gain U.S. approval</b></font></i>
    </p>
    <p style="text-align: center">
      <i><font style="font-family: Times New Roman; font-size: 12pt"><b>Strong
      pain reduction and overall symptom relief consistent with statistically
      significant results of CINGAL 13-01 Phase III placebo-controlled
      clinical study</b></font></i>
    </p>
    <p>
      BEDFORD, Mass.--(BUSINESS WIRE)--June 19, 2018--Anika Therapeutics, Inc.
      (NASDAQ: ANIK), a global, integrated orthopedic and regenerative
      medicines company specializing in therapeutics based on its proprietary
      hyaluronic acid (HA) technology platform, today announced results from
      its CINGAL<sup>&#174; </sup>16-02 clinical trial, an active-comparator
      Phase III study being conducted to support U.S. registration. CINGAL has
      previously been evaluated in a placebo-controlled Phase III clinical
      trial (13-01) that demonstrated safety and efficacy through 26-weeks.
      The 16-02 trial compared CINGAL, a combination of cross-linked HA and
      triamcinolone hexacetonide (TH), with TH alone and cross-linked HA in
      treating patients with osteoarthritis (OA) in the knee. The primary
      endpoint was a comparison of the pain reduction of CINGAL compared with
      TH alone at 26-weeks. While CINGAL achieved greater pain reduction
      numerically at every time point in the study, the difference at 26-weeks
      did not reach statistical significance.
    </p>
    <p>
      The patient response to CINGAL in the study was strong, as significant
      improvements in pain, function, and quality of life were observed at
      levels consistent with, and in most cases greater than, the results of
      the 13-01 placebo-controlled Phase III study of CINGAL. A strong safety
      profile was also shown, matching previous clinical studies as well as
      real-world experience from growing product use globally. The duration of
      pain reduction was also similar to the previous study as patient
      improvement after CINGAL injection was maintained near peak levels
      throughout the 26-week duration of the study. Follow-up of patients
      continues in a prospectively designed extension phase to the study,
      which will gather data through 39-weeks.
    </p>
    <p>
      Prof. Laszlo Hangody, MD, Ph.D., DSc., the global principal investigator
      of several CINGAL trials, said, &#8220;While it has been observed that TH has
      a longer duration of effect than other corticosteroids, the results in
      this study were surprising. Nevertheless, the patient response to CINGAL
      in this study was strong as patients received statistically and
      clinically meaningful rapid and long-lasting improvement in symptoms
      compared with base-line, consistent with the previous study as well as
      my experience in my practice. Taken together, the results of the two
      Phase III studies validate the effectiveness of this novel combination
      for use in patients with knee osteoarthritis.&#8221;
    </p>
    <p>
      CINGAL is the first and only commercially-available combination
      viscosupplement, and it is currently being used successfully by
      physicians to provide rapid and long-lasting relief from pain and
      discomfort caused by OA for patients in a growing number of countries.
      CINGAL is a patented formulation composed of the Company&#8217;s proprietary
      cross-linked sodium hyaluronate and triamcinolone hexacetonide. CINGAL
      is Anika&#8217;s third-generation viscosupplement, following the Company&#8217;s
      ORTHOVISC and MONOVISC products, to treat pain associated with
      osteoarthritis of the knee.
    </p>
    <div style="margin-right: 0pt; width: 100%; text-indent: 0pt; margin-bottom: 10pt; margin-left: 0pt">
      <div>
        <div style="text-align: left">

        </div>
      </div>
      <div style="page-break-after: always">
        <div style="text-align: center">

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

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

        </div>
      </div>
    </div>
    <p>
      Anika President and CEO Joseph Darling said, &#8220;OA patients continue to
      benefit from the proven safety and efficacy of CINGAL in growing numbers
      outside of the U.S. where CINGAL is approved. The benefits of combining
      HA and a corticosteroid are mirrored by physician feedback and
      real-world experience. While we expected CINGAL to perform as well as it
      did, we were surprised that the difference in pain reduction seen in
      this trial did not reach statistically significant levels at six months.
      We will however, continue to monitor the results of the ongoing 3-month
      extension study. We are actively reviewing the data and our plan is to
      work closely with regulators to come to an understanding of the next
      steps required to gain U.S. regulatory approval of CINGAL. We remain
      fully committed to bringing this impactful OA solution to U.S. patients
      and physicians.&#8221;
    </p>
    <p>
      <b>About Anika Therapeutics, Inc.</b>
    </p>
    <p>
      Anika Therapeutics, Inc. is a global, integrated orthopedic and
      regenerative medicines company based in Bedford, Massachusetts. Anika is
      committed to improving the lives of patients with degenerative
      orthopedic diseases and traumatic conditions with clinically meaningful
      therapies along the continuum of care, from palliative pain management
      to regenerative tissue repair. The Company has over two decades of
      global expertise developing, manufacturing, and commercializing more
      than 20 products based on its proprietary HA technology. Anika's
      orthopedic medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL,
      which alleviate pain and restore joint function by replenishing depleted
      HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and
      regeneration. For more information about Anika, please visit <u><i>www.anikatherapeutics.com</i></u><i>.</i>
    </p>
    <p>
      ANIKA, ANIKA THERAPEUTICS, CINGAL, HYALOFAST, MONOVISC, and ORTHOVISC
      are registered trademarks of Anika.
    </p>
    <p>
      <b>Forward-Looking Statements</b>
    </p>
    <p>
      The statements made in fifth paragraph of this press release as to the
      future activities and plans of the Company are forward-looking
      statements within the meaning of Section 27A of the Securities Act of
      1933 and Section 21E of the Securities Exchange Act of 1934. These
      statements, which reflect the current beliefs and expectations of the
      Company&#8217;s management, may be affected by inaccurate assumptions and by
      known and unknown risks and uncertainties that are difficult to predict
      or beyond the Company's control, including actions and decisions of
      regulatory authorities. Additional factors and risks are described in
      the Company's periodic reports filed with the Securities and Exchange
      Commission and available at <u><i>www.sec.gov</i></u><i>. </i>Forward-looking
      statements are based on information available to the Company on the date
      of this press release, and the Company assumes no obligation to update
      the information contained in this press release.
    </p>
    <p>
      CONTACT:<br>For Investor Inquiries: Anika Therapeutics, Inc.<br>Sylvia
      Cheung, Chief Financial Officer, 781-457-9000<br>or<br>For Media
      Inquiries: Pure Communications<br>Sonal Vasudev, 917-523-1418 <u>sonal@purecommunicationsinc.com</u>
    </p>
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