FDA approves Wyeth recombinant protein bone treatment for tibia fractures.

Wyeth, Inc., Madison, NJ, announced the US Food and Drug Administration (FDA) has approved ruBMP-2/ACS (recombinant human Bone Morphogenetic Protein-2Absorbable Collagen Sponge), a novel protein device that enhances bone healing, for use in the treatment of acute, open tibia shaft fractures in adults. The company says the device consists of rhBMP-2 intramedullary nail (a metal rod inserted into the bone) by orthopedic surgeons, after appropriate wound management.

Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, or dibotermin alfa), a recombinant version of a naturally occurring human protein, was discovered and developed by Genetics Institute, now a part of Wyeth.

In 2002, the European Commission approved the Marketing Authorization Application (MAA) for rhBMP-2ACS for use in the treatment of acute tibia fractures in adults in the European Union (EU). It is marketed under the name of InductOs, and introduced in the EU in July 2003.

Medtronic Sofamor Danek (MSD) will be marketing the product for tibia fractures, while purchasing the rhBMP-2 from Wyeth. Wyeth says it will receive royalties and milestone payments from MSD. The 2 companies have reached agreement to expand Medtronic's marketing rights to the product in the US, Canada, Australia, Latin America and other countries, for spine and tibia fracture indications. Medtronic will also have global marketing rights for the tibia fracture indication.

Contact: Douglas Petkus, Wyeth - [phone], Web site: www.wyeth.com