Why Is Breast Cancer Risk Reduction Important

1
Why Is Breast Cancer Risk Reduction Important?

• 2nd most common cause of cancer death in women
• 178,000 cases diagnosed annually
• 40,000 deaths annually
• Disease prevention remains an unmet need in
  breast cancer
• Identification of women at risk continues to
  improve
• Postmenopausal women need additional options to
  reduce risk of breast cancer

2
Raloxifene is aSelective Estrogen Receptor
Modulator

• Non-steroidal ligand of the estrogen receptor
• Has estrogen-like effects in some tissues
• Blocks estrogen effects in other tissues

Evista (raloxifene HCl 60 mg/day) is approved
for the prevention and treatment of osteoporosis
3
Raloxifene Development HistoryBreast Cancer
(1982-1998)

• 1982-1990 IND for treatment of Breast Cancer
  opened with the Oncology Division
• IND for osteoporosis opened with Endocrine
  Division
• MORE study initiated (breast cancer secondary
  endpoint)
• IND for invasive breast cancer risk reduction
  opened
• IND for STAR opened by NSABP
• RUTH study initiated (CV risk reduction)

4
Raloxifene Development HistoryBreast Cancer
(1999 present)

• CORE study initiated (follow-up to MORE
  invasive breast cancer primary endpoint)
• RUTH protocol amended to add invasive breast
  cancer as a second primary endpoint
• 2005 Pre-NDA meetings with the Oncology Division
• 2006 Invasive breast cancer risk reduction NDA
  submitted

5
Evista Current Indication
The prevention and treatment of osteoporosis.

• Proposed Additional Indication

The reduction in risk of invasive breast cancer
in postmenopausal women with osteoporosis.
6
Evista Current Indication
The prevention and treatment of osteoporosis.

• Proposed Additional Indication

The reduction in risk of invasive breast cancer
in postmenopausal women at high risk for breast
cancer.
7
Studied in More Than 37,000 PostmenopausalWomen
Across a Spectrum of Breast Cancer Risk

• Randomized active comparator trial
• Study of Tamoxifen and Raloxifene (STAR)
• Randomized placebo-controlled trials
• Raloxifene Use for The Heart Trial (RUTH)
• Multiple Outcomes of Raloxifene Evaluation (MORE)
• Placebo-controlled follow-up study of MORE
  participants
• Continuing Outcomes Relevant to Evista (CORE)

76,000 patient years of exposure to raloxifene