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 9, 2015
Anika
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Massachusetts |
000-21326 |
04-314-5961 |
(State or other jurisdiction of |
Commission file number |
(I.R.S. Employer |
32 Wiggins Avenue, Bedford, MA 01730 |
(Address of principal executive offices) (Zip code) |
Registrant’s
telephone number, including area code: 781-457-9000
(Former
name or former address, if changed since last report)
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:
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Section 8—Other Events
Item 8.01. Other Events.
On December 9, 2015, Anika Therapeutics, Inc. issued a press release to announce that the U.S. Food and Drug Administration’s Office of Combination Products has assigned the company’s CINGAL product to the Center for Drug Evaluation and Research as the lead center for premarket review of the product. The full text of the press release is furnished as Exhibit 99.1 hereto.
The exhibit attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") 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.
Section 9--Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release of Anika Therapeutics, Inc. dated December 9, 2015.
[Remainder of page left blank intentionally]
SIGNATURE
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.
Anika Therapeutics, Inc. |
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Dated: December 9, 2015 |
By: |
/s/ Sylvia Cheung |
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Sylvia Cheung |
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Chief Financial Officer |
Exhibit Index
99.1 |
Press Release of Anika Therapeutics, Inc. dated December 9, 2015. |
Exhibit 99.1
Anika Therapeutics Announces Decision to Proceed with CINGAL® Premarket Review Through FDA’s Center for Drug Evaluation and Research
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 & Drug Administration’s (FDA) Office of Combination Products has assigned CINGAL® to the Center for Drug Evaluation and Research (CDER) as the lead center for premarket review.
CINGAL is the first combination viscosupplement formulated with Anika’s proprietary cross-linked sodium hyaluronate (currently marketed as the single-injection viscosupplement MONOVISC®) 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.
“While we strongly disagree with the FDA’s decision, as our position of CINGAL’s device-lead classification is supported by both regulations and scientific data, we intend to proceed expeditiously to move CINGAL through regulatory review,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “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.”
CINGAL is Anika Therapeutics’ third-generation viscosupplementation product, adding to the Company’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®, 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.
About Anika Therapeutics, Inc.
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’s orthopedic medicine portfolio is comprised of
marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST®
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 http://www.anikatherapeutics.com.
Forward-Looking Statements
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’s leadership position in the viscosupplementation market. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’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’s ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST or for expanded indications of the Company’s MONOVISC product, on a timely basis or at all; (ii) the Company’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’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’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’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; (x) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (xi) the Company’s ability to achieve its growth targets.
CONTACT:
Anika Therapeutics, Inc.
Christopher Ranjitkar,
781-457-9000
IR & Corporate Communications Manager