Forsteo Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis

Eli Lilly and Company (NYSE:LLY) today announced that the European Commission has approved a new indication for FORSTEO(R) (teriparatide [rDNA origin] injection) for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. This approval follows the initial positive opinion issued in February by the Committee for Medicinal Products for Human Use (CHMP) of the EMEA.

Teriparatide stimulates new bone formation by increasing the number and action of bone-building cells called osteoblasts. Teriparatide, originally authorized for marketing in 2003 for the treatment of osteoporosis in postmenopausal women at high risk for fracture, received an expanded indication for the treatment of osteoporosis in men at increased risk for fracture in 2007.

"Chronic glucocorticoid therapy is the most common cause of secondary osteoporosis, often leading to bone loss and an increased risk for fracture," said Gwen Krivi, Ph.D., vice president of Lilly Research Laboratories. "We are pleased with the European Commission's decision to approve teriparatide for this new use."

Glucocorticoid-induced osteoporosis, or GIOP, is bone loss associated with chronic use of glucocorticoid medications. These medications are often prescribed for inflammatory conditions, such as rheumatoid arthritis and obstructive pulmonary disease. Globally, an estimated one to three percent of adults over the age of 50 use glucocorticoids. (1)

"Up to 50 percent of individuals on chronic glucocorticoid therapy will develop bone loss leading to an osteoporotic fracture,"(2) said Dr. Steven Boonen, professor of medicine at the Leuven University Centre for Metabolic Bone Diseases in Belgium. "This new indication for teriparatide provides physicians and patients with a new treatment option that builds bone."

The submission package to support the safety and efficacy profile of teriparatide included new data from the "Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis" study, which was published in the November 15, 2007 issue of the New England Journal of Medicine. This head-to- head comparative study showed that in patients with glucocorticoid-induced osteoporosis, teriparatide significantly increased lumbar spine bone mineral density (BMD) from baseline (7.2 percent) compared to alendronate (3.4 percent) at 18 months of therapy.(3)