US firm Anika Therapeutics, Inc. has extended its existing marketing and distribution relationship with Zurich-based Pharmaren AG, its ORTHOVISC distributor for Turkey, to include distribution rights for Egypt, where marketing approval has been received.
Anika also submitted the third and final module of a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for ORTHOVISC, a hyaluronic acid (HA) preparation for the treatment of osteoarthritis of the knee.
The final module includes data from the most recent ORTHOVISC clinical trial. The first two modules of the PMA, which included manufacturing and pre-clinical information, have already been reviewed by the FDA and all outstanding questions have been addressed.
Anika's PMA application to the FDA includes data from a Phase III clinical study, including approximately 360 patients at 24 centers in the US and Canada with monitoring for six months after treatment.
The trial was designed to evaluate the safety and effectiveness of ORTHOVISC in reducing joint pain and other symptoms of osteoarthritis of the knee. Osteoarthritis is a degenerative joint disease associated with aging that is characterized by joint pain, stiffness and the loss of mobility. More than 10 million Americans suffer from osteoarthritis of the knee.
"Assuming we receive approval from the FDA, this will open up a significant new market for ORTHOVISC," said Charles Sherwood, president and chief executive officer. Sherwood added that Anika is initiating discussions with prospective US marketing partners.
Having received CE Mark approval in 1996, ORTHOVISC is currently marketed in Canada, and several nations in Europe and the Middle East.
Headquartered in Woburn, Massachusetts, Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. — (menareport.com)
© 2003 Mena Report (www.menareport.com)
