To: peter chin who wrote (285 ) 8/5/1998 8:19:00 AM From: James Baker Read Replies (3) | Respond to of 642
Lilly's Evista Approved for Marketing in European Union Two-Year Data Show Osteoporosis Drug Reduces Fracture Risk, Results to be Presented in September INDIANAPOLIS, Aug. 5 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY - news) announced today that it has received approval from the European Commission (EC) to market Evista(R) (raloxifene hydrochloride) in 15 European Union member countries for the prevention of vertebral (spine) fractures in postmenopausal women at increased risk for osteoporosis. ''Lilly is proud to play a role in bringing the first selective estrogen receptor modulator (SERM) for osteoporosis rapidly to approval status in the European Union,'' said Gino Santini, president, SERMs and skeletal products division, Lilly Research Laboratories. ''The EC approval reaffirms that Evista protects postmenopausal women against osteoporosis, but also shows that Evista prevents painful fractures associated with the disease.'' The European Union approval marks the first regulatory review of data from the ongoing Multiple Outcomes of Raloxifene Evaluation (MORE) study, a clinical trial designed primarily to evaluate the effect of Evista on spine fractures and bone mineral density in women who have osteoporosis. These interim (two-year) data were evaluated in addition to data from osteoporosis prevention studies. The MORE study enrolled 7705 women in 25 countries worldwide. Updated analyses from the MORE trial will be presented at the European Congress on Osteoporosis, scheduled to take place in Berlin, September 11-15, 1998. These two-year interim results are expected to show that Evista produced a statistically significant reduction in the risk of spine fractures (by 38-52 percent) in osteoporotic women. Evista is now available in seven countries for the prevention of postmenopausal osteoporosis: the US, Mexico, Brazil, Israel, Argentina, Lebanon and Peru. Product registration is pending in 32 other countries worldwide. Data from the MORE trial will be submitted to other regulatory bodies for their review. Lilly is a global, research-based pharmaceutical corporation headquartered in Indianapolis, Ind., dedicated to creating superior healthcare solutions in order to help people live longer, healthy and more active lives. Women's health is a key area in which the company is focusing its efforts. Full prescribing information (US version) for Evista is available at www.evista.com.