Healthcare Industry News: DePuy
News Release - June 30, 2008
Anika Therapeutics Announces Commercial Availability of MONOVISC(TM) in Europe
Unique Osteoarthritis Treatment Provides Joint Pain Relief in a Single-Injection RegimenBEDFORD, Mass.--(HSMN NewsFeed)--Anika Therapeutics, Inc. (Nasdaq: ANIK ), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, today announced that it has begun shipping MONOVISC™ to Europe. MONOVISC is a single-injection viscosupplement therapy approved in the European Economic Area for treatment of osteoarthritis symptoms in all synovial joints. Other viscosupplements are indicated for specific joints, and may require up to five injections for the same treatment.
“MONOVISC is designed for faster pain relief and longer durability thanks to its proprietary cross-linking technology. MONOVISC’s single-injection regimen benefits both patients and physicians by minimizing the number of office visits, thereby lowering costs to the patient and the healthcare system,” said Charles H. Sherwood, Ph.D., Anika’s president and chief executive officer.
“MONOVISC is an important advancement in the care of osteoarthritis,” said Dr. Mauro Bausani, an investigator in the MONOVISC European clinical study. “We are excited that our recent clinical study data appears to replicate the safety and efficacy profile of ORTHOVISC® but in a single injection regimen.”
“The proprietary technology that we have developed for MONOVISC will form the core of our combination HA products for osteoarthritis treatment in the future,” continued Sherwood. “Our process of lightly cross-linking the hyaluronic acid polymers provides for enhanced durability while retaining all of the natural benefits of HA.”
The Company previously announced a randomized, double-blind, controlled study of MONOVISC that is taking place in the United States and Canada, and a separate clinical study that is ongoing at several European sites.
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 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 available in Europe; MONOVISC™ a single-injection osteoarthritis product based on its proprietary cross-linking technology 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 "expects," "anticipate," "intended," "opportunities," "will," "target," 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 concerning its MONOVISC product, and (ii) statements concerning the clinical study of MONOVISC. 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. These factors include the risk that (i) the Company's existing distributors or customers will not place orders for MONOVISC, (ii) the Company's efforts to enter into long-term marketing and distribution arrangements, including with new international distributors for MONOVISC, will not be successful, (iii) new distribution arrangements will not result in meaningful sales of the Company's products, (iv) competitive products will adversely impact the Company's product sales, or (v) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved, could have a material adverse effect on our results of operations, 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 "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 quarter ended March 31, 2008, as well as those described in the Company's other press releases and SEC filings.
Source: Anika Therapeutics
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