KUROS' BONE-REPAIR PRODUCT RECEIVES ORPHAN DRUG DESIGNATION

Kuros Biosurgery announced that the FDA has granted orphan drug designation to Kuros' bone-repair product, I-040302, for the treatment of solitary bone cysts. European regulators granted orphan drug status to the product last year. The company plans to begin a trial of I-040302 this year.

Solitary bone cysts are lesions that occur mostly in children between the ages of 9 and 14.

Orphan drug designation is granted to development-stage therapeutics that offer potential value in the treatment of rare diseases. In the U.S., the designation provides a variety of incentives, including seven years of market exclusivity, upon approval.

Kuros licensed the product to Baxter International in 2005 under an agreement focused on developing products for the regeneration of bone and soft tissue based on Kuros' biologics and delivery technologies and Baxter's Tisseel fibrin sealant matrix. I-040302 consists of a fusion protein derivative of human parathyroid hormone (PTH) and Tisseel. Upon administration, PTH is covalently incorporated into the fibrin matrix. Kuros' proprietary biologics delivery technology enables the controlled release of the bone-forming hormone at the site of the lesion.