ABCDEFGH
1Main
2Brand NameCrestor
3Generic Namerosuvastatin
4SafetyNLA study concludes Crestor did not stand out relative to other statins
5EconomicsShionogi
6IPIE case in USDC of DE. Judge Stark hearing SJ, Judge Farnar hearing patent.
7COM RE37,314 issued 8/01, expires 7/8/16.WPI received first final approval for generic on 6/12/2010.
8MOU 6858618 expires 2022. Claims HeFH.
9Salt 6316460 expires 2021. Claims salt and stability.
10Clinical Trials
11Phase III JUPITER n=15,000 - Terminated 3/31/2008 for efficacy
1244% risk reduction in CV morbidity/mortality vs placebo, HR=0.56.
1320% decrease in overall mortality.
14Patient population had normal LDL (<130) but elevated hsCRP (>2).
15Slight increase in diabetes.
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19METEOR study in Q4 - IVUS 24-month study of Crestor 40mg vs placebo n=800
20ASTEROID - demonstrated 40mg Crestor could reduce the degree of arterial occlusion in partients with CAD - shrinkage achieved high SS
21ORION - demonstrated 35.5% reduction in the lipid-rich necrotic core using MRI in n=39
22AURORA
23CORONA
24EXPLORER - Crestor+Zetia vs Crestor alone
25M05-748, n=1250, Crestor+ABT-335 - Study start March 06
26M05-749, n=560, simvastatin+ABT-335 - n=560 start in March 2006
27M05-750, n=560, lipitor+abt-335, start in march 2005
28M05-758, n=2370, crestor+ vs simva+ vs lipitor+ starts in may 2006