OP-1 moves forward in Australia:
Stryker Reports OP-1 Receives Positive Opinion From
Australian ADEC
KALAMAZOO, Mich., Feb. 16 /PRNewswire/ -- John W. Brown, Chairman,
President and Chief Executive Officer of
Stryker Corporation (NYSE: SYK - news) today announced that the Australian Drug
Evaluation Committee (ADEC) adopted
a positive opinion to recommend the granting of marketing authorization for OP-1
Implant (Osteogenic Protein 1) in Australia.
The ADEC opinion will now be considered by the Therapeutic Goods Agency (TGA),
which is expected to make the final
decision regarding marketing authorization in two to three months. Osteogenic Protein 1
is Stryker's patented recombinant
human protein, which initiates bone formation. The product recommended for marketing
authorization, OP-1 Implant, is a
combination of the OP-1 protein and a collagen carrier in a wetted paste, which is
surgically implanted into the bone defect.
The recommended indication is for the treatment of nonunion of long bone fractures
secondary to trauma for the purposes of
initiating repair by new bone formation.
Stryker develops, manufactures and markets specialty surgical and medical products,
including orthopaedic reconstructive,
trauma, spinal and craniomaxillofacial implants, powered surgical instruments, endoscopic
systems, patient care and handling
equipment for the global market, and provides outpatient physical therapy services in the
United States. |
