Number, Severity of Fractures, Predicts Future Risk New Analysis Showed Teriparatide Prevented Fracture Risk Associated With Increasing Number, Severity of Osteoporotic Fractures SEATTLE, Oct. 3 /PRNewswire-FirstCall/ -- Data presented today at the American Society for Bone and Mineral Research (ASBMR) 26th annual meeting show that the number and severity of prior fractures are strong predictors of future fractures in postmenopausal women with osteoporosis, and that FORTEO(R) (teriparatide [rDNA origin] injection) offered patients important protection against this risk. This new analysis of the Fracture Prevention Trial (initial results published in the New England Journal of Medicine, May 2001) included a subgroup of 931 postmenopausal women with severe osteoporosis who were given placebo or teriparatide 20 mcg (marketed as FORTEO). Patients in the placebo arm who had increasing number or severity of prior fractures had increasing risk for new vertebral (spine) fractures and for new nonvertebral fragility fractures during the study. These trends were not observed in women treated with FORTEO. FORTEO (teriparatide [rDNA origin] injection), the first and only bone formation agent approved for the treatment of osteoporosis, was granted FDA approval in November 2002. It stimulates new bone formation by increasing the number and activity of bone forming cells called osteoblasts. FORTEO is approved for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men (and postmenopausal women) with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. Until FORTEO's approval, the only approved osteoporosis treatments were antiresorptives, which work mainly to slow or stop bone loss by reducing the number and action of bone-removing cells called osteoclasts. About the Analysis To determine the relationship between baseline fracture history and future fracture risk, spine radiographs of 931 postmenopausal women with vertebral fractures were evaluated at baseline (beginning of the study) and after an average of 21 months. Additionally, the number of prior nonvertebral fractures were collected, and new nonvertebral fractures occurring during the trial were tabulated. Findings showed that in the placebo group, an increasing number and severity of prior vertebral and nonvertebral osteoporotic fractures were associated with a significant increase in new fracture risk. In women with mild, moderate, and severe vertebral fractures at study entry, the risk for vertebral fracture during the study was 9.6%, 12.9%, and 28.4%, respectively. Additionally, in women with zero, one, and two or more prior nonvertebral fractures at study entry, the risk for new nonvertebral fractures was 3.6%, 8.2%, and 18%, respectively. These significant trends for escalating risk of new fractures in women with increasing prior fracture burden were not observed in women treated with FORTEO. Important Safety Information about FORTEO In two-year studies in rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor, which was dependent on dose and duration of treatment. Although no case of osteosarcoma has been reported in the patients who received FORTEO in clinical trials, it is not known if humans treated with FORTEO are at increased risk for this cancer. FORTEO should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. The drug should not be prescribed for patients at increased baseline risk for osteosarcoma, including patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, children or growing adults, or those who have had prior external beam or implant radiation therapy involving the skeleton. Additionally, patients with bone metastases or a history of skeletal malignancies, and those with metabolic bone diseases other than osteoporosis, should not receive FORTEO. Patients with high levels of calcium in their blood should not receive FORTEO due to the possibility of increasing their blood levels of calcium. In clinical trials, the most frequent treatment-related adverse events reported at the 20-microgram (mcg) dose approved for marketing were mild, similar to placebo and generally did not require discontinuation of therapy. Reported adverse events that appeared to be increased by FORTEO treatment were leg cramps and dizziness (2.6 and 8 percent, respectively), compared with placebo (1.3 percent and 5.4 percent, respectively). FORTEO is supplied in a disposable pen device that can be used for up to 28 days to give once-daily self-administered injections. FORTEO is available in a 20-mcg dose and should be taken for a period of up to 24 months. Lilly has implemented a risk management program that includes comprehensive measures regarding the appropriate use of FORTEO in the target patient population. A Medication Guide explaining the details of the drug to the patient also accompanies the product. FORTEO also has a black box warning in its package insert about the osteosarcoma findings in rats during preclinical testing. For complete prescribing information, please visit http://www.forteo.com/ . About Osteoporosis More than 50 percent of all women over the age of 75 are estimated to have osteoporosis, and due to their advanced age, have a high risk of fracture. In fact, most American women over the age of 50 will experience one or more osteoporosis-related fractures during their lifetimes, and women with osteoporosis who have two or more previous fractures have up to a nine times greater risk of future fracture compared with women who have not suffered a previous fracture. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ . (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE: Eli Lilly and Company CONTACT: Keri S. McGrath of Eli Lilly and Company, cell: +1-317-457-5613, office: +1-317-651-6001, or email:

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