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Anika Therapeutics Expands Territory in Europe for ORTHOVISC to Germany and France.


Business & Health Editors

WOBURN, Mass.--(BUSINESS WIRE)--Sept. 10, 2003

Anika Therapeutics, Inc. (Nasdaq:ANIK ANIK Canadian COMSAT ) today announced it has expanded its marketing and distribution partnership with Vita Research srl, based in Rome, Italy, for ORTHOVISC(R), Anika's treatment for osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
 of the knee, to now include Germany and France.

"For the past two years, Vita Research has proven to be a great partner for Anika in Italy and has done a commendable job with ORTHOVISC in that country," said Charles H. Sherwood, Ph.D., president and chief executive officer. "We are delighted to extend this partnership to include two of the regions largest potential markets and look forward to working closely to support Vita Research's efforts in both Germany and France."

Sherwood noted that ORTHOVISC already is approved for commercialization in Europe, and marketing efforts are expected to commence in Germany this month. In France, the company first will seek reimbursement approval before commercialization efforts begin. Vita Research currently has offices and sales representation in both countries. Current estimates indicate that the European market is approximately $80 million.

ORTHOVISC currently is approved for sale and is being marketed in Canada, the United Kingdom, Italy, Spain, Portugal, Turkey, Greece and Israel. In May 2003, Anika filed a pre-market approval (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) application to the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for ORTHOVISC to market the product in the U.S.

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 hyaluronic acid: see mucopolysaccharide.
Hyaluronic acid

A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints.
 (HA), a naturally occurring, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function.  polymer found throughout the body. In addition to ORTHOVISC(R), a treatment for osteoarthritis of the knee (not approved for sale in the U.S.), Anika markets HYVISC(R) in the U.S. for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC(R) and AMVISC(R) Plus, HA viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties
natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics"
 products for ophthalmic surgery, for Bausch & Lomb. It also produces CoEase(TM), which is marketed by Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc., STAARVISC(TM)-II, distributed by STAAR STAAR Second Time Around Aussie Rescue, Inc. (Bryan, TX)
STAAR Space Technology Applications Astronomy & Rocket Research (Scottish Rocket Programme) 
 Surgical Company, and Shellgel(TM) for Cytosol cytosol /cy·to·sol/ (sit´ah-sol) the liquid medium of the cytoplasm, i.e., cytoplasm minus organelles and nonmembranous insoluble components.cytosol´ic

cy·to·sol
n.
 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. These statements also include statements regarding: (i) the Company's efforts and expectations in entering into long-term arrangements to market and distribute ophthalmic and osteoarthritis products, (ii) the level of the Company's revenue or sales in particular geographic areas and/or for particular products, (iii) expectations regarding future results of operations, (iv) the Company's goal of obtaining FDA approval for ORTHOVISC(R), (v) the Company's expectations of the size of the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and European markets, including Germany and France, for osteoarthritis of the knee, and (vi) the Company's intention to increase market share for ORTHOVISC(R) in international (and, eventually, domestic) markets or otherwise penetrate growing markets for osteoarthritis of the knee. 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 on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, including ORTHOVISC(R), or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the cost effectiveness and efficiency of our manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations.  and production planning; (iii) the strength of the German and French economies in general and other economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; or (iv) future determinations by the Company to allocate resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the Company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the Company's existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) the Company's efforts to enter into long-term marketing and distribution arrangements will not be successful, including enlisting a domestic distribution partner for ORTHOVISC(R), (iii) new distribution arrangements will not result in meaningful sales of the Company's products, or (iv) increased sales of the Company's products, including HYVISC(R) or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, any of which may have a material adverse effect on the Company's business and operations. 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 Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
 of Financial Condition and Results of Operations" in each of the Company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2002, its Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the quarter ended June 30, 2003 and Current Reports on Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
, as well as those described in the Company's other press releases and SEC filings.
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Publication:Business Wire
Geographic Code:1USA
Date:Sep 10, 2003
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