-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RbvZLTDBwu71f3ZuTjzsKQ+Yp//E+gGwYj2Mag/M5UVyqhNodph/CFtta/eXBrnB 9RMv7IqcPkxCzhQ90jGuoQ== 0001104659-03-027713.txt : 20031203 0001104659-03-027713.hdr.sgml : 20031203 20031203160051 ACCESSION NUMBER: 0001104659-03-027713 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031202 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031203 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANIKA THERAPEUTICS INC CENTRAL INDEX KEY: 0000898437 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] 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: 031035412 BUSINESS ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 6179326616 MAIL ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 FORMER COMPANY: FORMER CONFORMED NAME: ANIKA RESEARCH INC DATE OF NAME CHANGE: 19930309 8-K 1 a03-5966_18k.htm 8-K

 

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 2, 2003

 

Anika Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Massachusetts

 

000-21326

 

04-3145961

(State or Other Jurisdiction of
Incorporation or Organization)

 

(Commission file
Number)

 

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

 

 

 

 

 

160 New Boston Street, Woburn, Massachusetts

 

01801

(Address of Principal Executive Offices)

 

(Zip Code)

 

 

 

Registrant’s Telephone Number, Including Area Code: (781) 932-6616

 

 



 

Item 5:  Other Events and Required FD Disclosure.

 

On December 2, 2003, Anika Therapeutics, Inc. issued a press release (“Press Release”) announcing that it had received an approvable letter from the U.S. Food and Drug Administration regarding its ORTHOVISCÒ osteoarthritis product.  A copy of the Press Release is attached hereto as Exhibit 99.1 and incorporated herein by reference in its entirety.

 

Item 7:  Financial Statements, Pro Forma Financial Information and Exhibits.

 

(c) Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Anika Therapeutics, Inc. on December 2, 2003

 

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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, thereunto duly authorized.

 

 

ANIKA THERAPEUTICS, INC.

 

 

December 2, 2003

By:

/s/  Charles H. Sherwood

 

 

 

Charles H. Sherwood, Ph.D.

 

 

Chief Executive Officer and President

 

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Exhibit Index

 

Exhibit No.

 

Description

99.1

 

Press Release of Anika Therapeutics, Inc. dated December 2, 2003

 

4


EX-99.1 3 a03-5966_1ex99d1.htm EX-99.1

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Contact:

 

Anika Therapeutics, Inc.

Pondel/Wilkinson Klein

Charles Sherwood, Ph.D., CEO

Susan Klein (508) 358-4315

William Knight, CFO

Rob Whetstone (323) 866-6060

(781) 932-6616

 

 

ANIKA THERAPEUTICS RECEIVES APPROVABLE LETTER FOR ORTHOVISC®

OSTEOARTHRITIS PRODUCT FROM FDA

 

WOBURN, Mass. – December 2, 2003 Anika Therapeutics, Inc. (NASDAQ:ANIK) today said it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its Pre-Market Approval application (PMA) for ORTHOVISC®, a highly purified, high molecular weight form of hyaluronic acid for treating patients suffering from osteoarthritis of the knee.  The letter states that an approval order will be issued subject to a successful FDA inspection of Anika’s manufacturing facility.

 

“This achievement marks a significant milestone for Anika Therapeutics and we are pleased with the outcome of the FDA’s review of our PMA application thus far,” said Chief Executive Officer Charles H. Sherwood, Ph.D.  “One of our top corporate priorities is to now focus on securing an agreement with a strategic U.S. partner who will lead the commercialization efforts for ORTHOVISC.”

 

Designed to relieve pain and stiffness and improve joint mobility, ORTHOVISC has been marketed internationally since 1996, and currently is sold in Canada and various European and Middle Eastern nations.  The U.S. market for viscosupplementation products is growing, with currently over 10 million Americans suffering from osteoarthritis of the knee.

 

About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue.  These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body.  In addition to ORTHOVISC®, a treatment for osteoarthritis of the knee (not approved for sale in the U.S.), Anika markets HYVISC® in the U.S. for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC® and AMVISC® Plus, HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb.  It also produces CoEaseTM, which is marketed by Advanced

 

(more)

 



 

Medical Optics, Inc., STAARVISCTM-II distributed by STAAR Surgical Company and ShellgelTM for Cytosol Ophthalmics, Inc.

 

The statements made in 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 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as “expectations,” “remains,” “focus,” “expected,” “prospective,” “expanding,” “building,” “continue,” “progress,” “efforts,” “hope,” “believe,” “objectives,” opportunities,” “will,” “seek,” and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements.  The statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties.  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:  the results of its research and development efforts and timing of regulatory approvals; approval and commercialization of the Company’s products, and, with respect to Orthovisc, risks relating to the ability of the Company to successfully address the requests of the FDA in the approvable letter referred to above and the timing of the Company’s efforts to do so, as well as the timing of any approved order; and the Company’s ability to enlist a domestic distribution partner for Orthovisc or the risk that any such distribution arrangement will not result in meaningful sales.  There can be no assurances that the Company’s increased unit sales will materially increase product revenue or improve gross margins.  Certain other factors that might cause the Company’s actual results to differ materially from those in the forward-looking statements include those set forth under the headings “Business,” “Risk Factors and Certain Factors Affecting Future Operating Results” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in each of the Company’s Annual Report on Form 10-K for the year ended December 31, 2002, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 and Current Reports on Form 8-K, as well as those described in the Company’s other press releases and SEC filings.

 

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