<0> Research and Markets: The Medicines Company's Cangrelor - Is it better than Plavix for Acute Coronary Syndrome? </0>
<0> Research and MarketsLaura Wood, Senior ManagerU.S. Fax: 646-607-1907Fax (outside U.S.): +353-1-481-1716Sector: </0>
() has announced the addition of the report to their offering.
Cangrelor is a reversible, intravenous inhibitor of the P2Y12 receptor whose effect is to inhibit adenosine diphosphate-induced platelet aggregation. The Medicines Company is developing it for use in the setting of patients undergoing percutaneous coronary intervention procedures (PCI), specifically those who have not used Plavix or other P2Y12 inhibitors in the prior week. Two previous phase III trials failed to meet their primary endpoints. Thus, approval hangs on the results of a third trial, CHAMPION-PHOENIX that should report before year-end. This report explores the probability of a favorable phase III outcome, eventual approval, and the market opportunity.
1. Acute coronary syndromes (ACS)
2. Thrombosis is at the center of causality
3. Clinicians use several approaches to platelet inhibition
1. Phase I/II trials
2. Pivotal trials
CLINICAL AND REGULATORY DISCUSSION
1. Why did CHAMPION-PCI and CHAMPION-PLATFORM fail?
2. Given the PCI and PLATFORM results, what are the lessons for PHOENIX?
3. Are there meaningful safety concerns associated with cangrelor?
4. Are there any bleeding concerns?
5. Possible adverse pulmonary effects of cangrelor
6. What are the regulatory issues that cangrelor will face?
7. Other relevant FDA guidance
8. In summary
1. Overview of issues
2. Market estimates
3. Pipeline products
- Eli Lilly,
- Bristol Myers Squibb,
- Astra Zeneca
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