Anika Therapeutics receives European stamp of approval for cosmetic dermatology product

Anika Therapeutics has announced that it has received CE Mark certification for the commercial sale of its cosmetic dermatology product, ELEVESS, 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.