Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Os...(issions were based on efficacy and safet...)

Date:8/19/2007

issions were based on efficacy and safety data from a three-year Pivotal Fracture Trial, showing that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (i.e. hip, wrist, arm, leg, rib). Reclast is the only treatment proven to reduce fractures across all of these key sites.

In this study involving more than 7,700 women, Reclast reduced the risk of spine fractures by 70% and hip fractures by 41% (The New England Journal of Medicine, May 3, 2007)(2). The reduction in spine fractures was sustained over three years (60% in year one, 71% in year two, and 70% in year three). Bone mineral density increased significantly in the spine by 6.7% and the hip by 6% in women on Reclast compared to placebo(2).

"Reclast has shown significant efficacy in protecting women against fractures in all the common osteoporotic fracture sites, while demonstrating a favorable safety profile," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "It is our hope that this innovative once-yearly dosing regimen will have a positive impact on the management of this potentially devastating condition."

The need for effective treatments is pressing, with one out of every two women over the age of 50 suffering an osteoporotic fracture in her lifetime(1). The disease is responsible for 1.5 million fractures in the US every year(1), some of which can have severe consequences. Approximately 20% of women over the age of 50 who suffer a hip fracture will die within one year(1).

Osteoporotic fractures are responsible for an estimated 800,000 emergency room visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6 million physician visits in the US each year(3), costing the healthcare system approximately $12.2 to 17.9 billion annually(3).

"Osteoporosis is a serious disease affecting millions of people in this country," said Leo Schargorodski, e
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SOURCE Novartis Pharmaceuticals Corporation Copyright©2007 PR Newswire.

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