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| Melphalan in a Nutshell |
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Markets |
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- Over 50,000 patients in the U.S. suffer from multiple myeloma with about 16,000 new cases being diagnosed annually
- Melphalan is an approved injectable therapy marketed under the brand name Alkeran, which generated sales of $50 million in 2006 in multiple segments including off-label use
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Product Advantages |
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- Alkeran is currently packaged as two separate vials that must be combined prior to use; stable for up to two hours after mixing
- Captisol Enabled Melphalan IV is a one vial formulation of melphalan, will have a longer use time after mixing with saline and increased stability
- Alkeran must be administered shortly after mixing
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Development Status |
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- Currently finalizing the formulation of Captisol Enabled Melphalan IV
- Expected to initiate the bioequivalence study by the end of 2008 and, if the study is successful, submit NDA in late 2009
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| Updated: May 29, 2008 | |
