Bio-Technology General Corp. has entered into an exclusive agreement with DePuy Orthopaedics Inc. (DePuy), for BioHy, BTG’s proprietary high molecular weight sodium hyaluronate product, for the treatment of pain associated with osteoarthritis of the knee.
The agreement grants DePuy exclusive marketing rights to BioHy in all countries worldwide except Japan and Israel.
Clinical efforts, where required, and applications for regulatory approvals will be undertaken by DePuy in the licensed territory except in Europe, where BTG is currently conducting a Phase III safety and efficacy study of the product.
The randomized, double-blind study is comparing BioHy with Synvisc, a well accepted commercial product in the European viscoelastic market for osteoarthritis of the knee.
Completion of the study, to be followed by a regulatory submission for approval to market BioHy in Europe, is anticipated this year.
Sim Fass, Chairman and CEO of Bio-Technology General Corp., stated: “We are extremely pleased to have forged this important relationship with such a strong leader worldwide in the orthopedics arena. We believe that because of the alliance with DePuy, BioHy will be well positioned to make a significant impact on the market for viscoelastic products for osteoarthritis.”
Bio-Technology General Corp., develops, manufactures and markets genetically engineered and other products for human health care.
The Company’s products are marketed in over thirty countries worldwide.
DePuy, a leading orthopedic company, focuses on products for total hip and extremity implants, and total knee implants, as well as on surgical equipment and environmental protection products.