0001157523-15-004010.txt : 20151209 0001157523-15-004010.hdr.sgml : 20151209 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 8-K 1 a51240500.htm ANIKA THERAPEUTICS, INC. 8-K

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
incorporation or organization)

Commission file number

(I.R.S. Employer
Identification No.)

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.

 

Dated: December 9, 2015

By:

/s/ Sylvia Cheung

 

Sylvia Cheung

 

Chief Financial Officer


Exhibit Index

99.1  

Press Release of Anika Therapeutics, Inc. dated December 9, 2015.

EX-99.1 2 a51240500ex99_1.htm EXHIBIT 99.1

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