WOBURN, Mass., April 12 /PRNewswire-FirstCall/ -- Anika Therapeutics, Inc. today announced that it has received CE Mark certification for the commercial sale of its cosmetic dermatology product, ELEVESS(TM), in the European Union. ELEVESS is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. The product is based on Anika's chemically modified hyaluronic acid (HA) technology, and incorporates lidocaine, a local anesthetic.
"Receiving CE Mark approval for ELEVESS is a milestone in our commercialization efforts with Galderma, our worldwide distribution partner," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "ELEVESS is designed for longer durability thanks to its new proprietary cross linking technology and its higher concentration of HA. In addition, ELEVESS will be the first HA product containing lidocaine to be commercialized for use in cosmetic dermatology. Lidocaine improves patient comfort and satisfaction providing physicians with a new alternative for their aesthetic practice." A supplement to the PMA for US approval of ELEVESS has been filed with the FDA. As previously announced the commercial launch of ELEVESS in the EU and around the world is expected to commence in the second half of 2007.
The global market for cosmetic fillers is estimated at approximately $600 million, with the EU representing approximately 25% of that market. According to a recent study by the American Society for Aesthetic Plastic Surgery, non- surgical procedures using HA soft tissue fillers grew at an annual rate of 35%.
ELEVESS is the first in a family of products expected to be developed in partnership with Galderma. The commercialization of ELEVESS is aligned with Galderma's strategy to offer a wide range of corrective and aesthetic treatments, complementing its family of therapeutic solutions. Galderma's performance and reputation for success has established them as one of the premier global dermatology companies.
About Anika Therapeutics, Inc.
Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (http://www.anikatherapeutics.com/) 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 products include ORTHOVISC(R), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek, and HYVISC(R), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika manufactures Amvisc(TM) and Amvisc Plus(TM), HA viscoelastic products for ophthalmic surgery. It also produces STAARVISC(TM)-II, which is distributed by STAAR Surgical Company and Shellgel(TM) 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 "expected," "efforts," "approves," "aligned," "established," "estimated" "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 goal to obtain U.S. marketing approval for ELEVESS(TM), (ii) the company's expectations regarding its cosmetic dermatology products, and (iii) its commercialization plans for ELEVESS(TM). 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, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the company's research and product development efforts and their relative success, including whether the company has any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of our manufacturing operations and production planning; (iv) the strength of the economies in which the company operates or will be operating, as well as the political stability of any of those geographic areas or (v) 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. 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, 2006, and Current Reports on Form 8- K, as well as those described in the company's other press releases and SEC filings. The company expressly disclaims any current intention or obligation to update any forward-looking statements in this press release to reflect future events or changes in facts affecting the forward-looking statements contained in this press release.
Contacts:
Charles H. Sherwood, Ph.D., CEO
Kevin W. Quinlan, CFO
Anika Therapeutics, Inc.
(781) 932-6616
