Anika : Research and Development

Anika Therapeutics’ research and development initiatives focus on creating products that address important markets and leverage our patents and formulation and manufacturing expertise related to chemically modified hyaluronic acid (HA). A key advantage of chemically modified HA is the ability to tailor residence time in the body. Our scientists are developing bioabsorbable products that can be timed to remain in place for six months or longer.

The two most advanced therapies in Anika’s product pipeline are INCERT,^® a gel-like barrier designed to prevent post-surgical tissue adhesions, and a cosmetic tissue augmentation (CTA) therapy that can act as a soft tissue filler for facial wrinkles, scar remediation and lip augmentation. The company entered into pilot human trials for INCERT in April 2004. Pivotal human trials for CTA are planned in 2004.

Potential applications Anika may explore in the future are injectable solutions or gels that can be combined with other compounds or entities such as cells, growth factors and genes. We are also investigating the timed degradation of matrix materials for localized drug delivery.

Enhancing and extending existing product lines is another key research and development focus. We are developing second-generation versions of our ophthalmic and osteoarthritis products. These include a pH-buffered ophthalmic viscoelastic and an osteoarthritis product that can be stored at room temperature. Potential extensions to our osteoarthritis line include therapies for osteoarthritis of the thumb, shoulder, ankle and hip joints.

INCERT^®
INCERT is a family of bioabsorbable, chemically modified hyaluronic acid (HA) therapies intended to act as a barrier to prevent internal tissue adhesion and scarring following spinal, cardiac, pelvic or abdominal surgery. These can lead to recurrent back pain, female infertility and intestinal blockage, sometimes necessitating costly second surgeries to eliminate scar tissue or adhesions. Anika's chemically modified HA anti-adhesion product shows considerable promise based on preclinical animal models. The company has entered into human pilot trials for INCERT in Europe in conjunction with spinal surgery. (INCERT has not been approved for sale in the United States.)

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Cosmetic Tissue Augmentation
Anika Therapeutics is developing a family of products for the treatment of dermal defects, including fine lines, folds and scars. These products may be injected into the skin or lips to smooth contour depressions or add volume. These therapies are designed to be slowly reabsorbed by the body, providing long-term retention in treated tissue sites.

Chemically modified HA has the capacity to hold more water than other natural or synthetic polymers, thereby increasing the resistance of tissues to compression. The unique biophysical characteristics and the inherent safety of HA make it an ideal material for treatment of dermal defects.

Demand for facial injectable and implant therapies is expected to grow with the aging of the baby boom population and as new products are introduced to replace bovine collagen treatments on the market since 1981. We plan to enter pivotal U.S. human trials for a cosmetic tissue augmentation indication in 2004. (CTA has not been approved for sale in the United States.)

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