Profile: Anika Therapeutics Inc (ANIK.O)

Anika Therapeutics, Inc. (Anika), incorporated in 1992, 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. Its manufactured and marketed products consist of ORTHOVISC, which is an HA product used in the treatment of some forms of osteoarthritis in humans; AMVISC, AMVISC Plus, STAARVISC-II and ShellGel, each an injectable ophthalmic viscoelastic HA product; HYVISC, which is an HA product used in the treatment of equine osteoarthritis, and INCERT, an HA-based, anti-adhesive for surgical applications. ORTHOVISC mini, a treatment for osteoarthritis targeting small joints is available in Europe. MONOVISC, a single-injection osteoarthritis product based on its cross-linking technology is available in Europe and Turkey. In December 2009, the Company announced that it has acquired Fidia Advanced Biopolymers, s.r.l.

In the United States, ORTHOVISC is marketed by DePuy Mitek, Inc. (DePuy Mitek), a subsidiary of Johnson & Johnson (collectively, JNJ), under the terms of a licensing, distribution, supply and marketing agreement. Outside the United States, ORTHOVISC is marketed by distributors in approximately 16 countries. The Company developed and manufactures AMVISC and AMVISC Plus for Bausch & Lomb Incorporated under a multiyear supply agreement. HYVISC is marketed in the United States through Boehringer Ingelheim Vetmedica, Inc. INCERT is marketed in three countries outside of the United States. ELEVESS is designed as a family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation. Anika’s initial ELEVESS product is approved in the United States, European Union, Canada and certain countries in South America, and is manufactured by Anika. Products in development include next generation osteoarthritis / joint health related products and ELEVESS line extension products. During the year ended December 31, 2008, revenue from the sale of its products contributed 92% of the Company’s total revenue. Revenue from the sale of ophthalmic viscoelastic products was 32% of product revenue. The Company’s joint health products contributed 57% of its product revenue, and HYVISC contributed 9% of its product revenue in 2008.

Osteoarthritis Business

Anika’s joint health products include ORTHOVISC, ORTHOVISC mini and MONOVISC. MONOVISC is a single injection osteoarthritis treatment for all joints, and is available in Europe and Turkey. ORTHOVISC mini and MONOVISC are the Company’s two new joint health products. In the United States, ORTHOVISC is indicated for the treatment of pain caused by osteoarthritis of the knee in patients, who have failed to respond adequately to conservative non-pharmacologic therapy and to analgesics, such as acetaminophen. ORTHOVISC has been approved for use in all joints in Europe and certain other international markets. It is a sterile, clear, viscoelastic solution of hyaluronan dissolved in physiological saline, and dispensed in a single-use syringe. ORTHOVISC is injected into joints in a series of three intra-articular injections one week apart.

Ophthalmic Business

The Company’s ophthalmic business includes HA viscoelastic products used in ophthalmic surgery. The ophthalmic products Anika manufactures include the AMVISC and AMVISC Plus product line, STAARVISC-II and ShellGel. They are injectable, high molecular weight HA products used as viscoelastic agents in ophthalmic surgical procedures, such as cataract extraction and intraocular lens implantation. These products coat, lubricate and protect sensitive tissue, such as the endothelium, and maintain the shape of the eye, thereby facilitating ophthalmic surgical procedures.

Veterinary Business

HYVISC is a high molecular weight injectable HA product for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine osteoarthritis. HYVISC has viscoelastic properties that lubricate and protect the tissues in horse joints. HYVISC is distributed by Boehringer Ingelheim Vetmedica, Inc. in the United States.

Anti-adhesion Business

INCERT is designed as a family of HA-based products, with chemically modified, cross-linked HA, for prevent of post-surgical adhesions. Surgical adhesions occur when fibrous bands of tissues form between adjacent tissue layers during the wound healing process. INCERT is marketed in three countries.

Aesthetic Dermatology Business

ELEVESS is designed as a family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation, and is intended to supplant collagen-based products. The Company’s aesthetic dermatology product is a dermal filler-based on its chemically modified, cross-linked HA.