Anika Therapeutics Completes Enrollment In MONOVISC™ Pivotal U.S. Clinical Trial

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopaedics;  Clinical Trials / Drug Trials
Article Date: 05 Dec 2008 - 1:00 PDT

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Anika Therapeutics, Inc. (NASDAQ:ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, announced today that it has completed enrollment for its pivotal U.S. clinical trial for MONOVISC™. The randomized, double-blind, controlled study is designed to demonstrate that the single-injection MONOVISC safely provides symptomatic relief of knee pain in patients with osteoarthritis. Anika enrolled approximately 350 patients at sites in the U.S. and Canada for the study, which includes a six-month follow-up period. The Company expects to commence commercialization in the United States in 2010.

"Completing the enrollment of the U.S. trial for MONOVISC brings us closer to the domestic commercialization of our single-injection osteoarthritis product," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "MONOVISC is being very well received in Europe, where we launched the product in May. Coincident with that launch, we completed a post-approval study of MONOVISC in Europe and the interim results on the product's performance and duration of action are very strong."

About MONOVISC™

MONOVISC is Anika's next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. It is the only single-injection viscosupplement therapy approved for relief of joint pain in all synovial joints. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit http://www.monovisc.com.

About Anika Therapeutics, Inc.

Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products include ORTHOVISC®, a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC®, a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; the ELEVESS™ family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation; AMVISC®, AMVISC® Plus, STAARVISC™-II and Shellgel™ injectable viscoelastic HA products for ophthalmic surgery; INCERT®, an HA-based anti-adhesive for surgical applications; ORTHOVISC® mini a treatment for osteoarthritis targeting small joints and available in Europe; MONOVISC™ a single-injection osteoarthritis product based on its proprietary cross-linking technology and available in Europe; and next generation products for joint health and aesthetic dermatology based on the Company's proprietary, chemically modified HA.

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," "expanded," "building," "continued," "progress," "plan(s)," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," "expect," "invest," "signing," "on track" 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: (i) the company's expectations regarding its pivotal U.S. trial for MONOVISC, (ii) the timing of commercialization of MONOVISC in the United States, and (iii) the results of the company's post-marketing study in Europe. 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. 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 "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, 2007 and on Form 10-Q for the periods ended March 31, June 30, and September 30, 2008, as well as those described in the company's other press releases and SEC filings.

Anika Therapeutics, Inc.