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| Main | | | | | | | |
| Brand Name | Crestor | | | | | |
| Generic Name | rosuvastatin | | | | | |
| Safety | NLA study concludes Crestor did not stand out relative to other statins | | | | | |
| Economics | Shionogi | | | | | |
| IP | IE case in USDC of DE. Judge Stark hearing SJ, Judge Farnar hearing patent. | | | | | |
| | COM RE37,314 issued 8/01, expires 7/8/16. | | | | | WPI received first final approval for generic on 6/12/2010. |
| | MOU 6858618 expires 2022. Claims HeFH. | | | | | |
| | Salt 6316460 expires 2021. Claims salt and stability. | | | | | |
| Clinical Trials | | | | | | |
| | Phase III JUPITER n=15,000 - Terminated 3/31/2008 for efficacy | | | | | |
| | 44% risk reduction in CV morbidity/mortality vs placebo, HR=0.56. | | | | | |
| | 20% decrease in overall mortality. | | | | | |
| | Patient population had normal LDL (<130) but elevated hsCRP (>2). | | | | | |
| | Slight increase in diabetes. | | | | | |
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| | METEOR study in Q4 - IVUS 24-month study of Crestor 40mg vs placebo n=800 | | | | | |
| | ASTEROID - demonstrated 40mg Crestor could reduce the degree of arterial occlusion in partients with CAD - shrinkage achieved high SS | | | | | |
| | ORION - demonstrated 35.5% reduction in the lipid-rich necrotic core using MRI in n=39 | | | | | |
| | AURORA | | | | | |
| | CORONA | | | | | |
| | EXPLORER - Crestor+Zetia vs Crestor alone | | | | | |
| | M05-748, n=1250, Crestor+ABT-335 - Study start March 06 | | | | | |
| | M05-749, n=560, simvastatin+ABT-335 - n=560 start in March 2006 | | | | | |
| | M05-750, n=560, lipitor+abt-335, start in march 2005 | | | | | |
| | M05-758, n=2370, crestor+ vs simva+ vs lipitor+ starts in may 2006 | | | | | |