Who’s Afraid Of A Pill? Not Isis CEO Stan Crooke

We reported every side effect in gory detail… And we believe the liver safety is significantly better and will be proven out in medical practice. Kynmaro lowers all athrogenic lipids and increases HDL based on the study and we think this will matter greatly to lipidologists. Pharmalot: How do you convince insurers? Crooke: The evidence of the value Kynamro brings is overwhelming and the benefit in terms of cv events is observed in a two-to five-year timeframe, which is relevant to payers… From what Genzyme tells us, there’s a been a favorable response. It’s a very specific equation that has to be written for each drug… But a 50 percent reduction in cv risk in people with one or two heart attacks is worth a lot. Pharmalot: Do you see foresee a lot of pediatric usage? Crooke: It’s been studied in children as young as 12, but we don’t have sufficient experience in children.. We’re gaining additional experience in additional trials… It’s marketed under a REMS and being a physician myself, I know what I would do, but clearly, off label use is not something Genzyme will encourage or I would comment on… Pharmalot: What’s the status with gaining approval in Europe? Crooke: We’ve applied for re-examination and we’re well along in that process and very optimistic that we will gain approval.. It’s an individual value proposition and that equation is written for every drug and for every patient. The key for prospering in the new discovery and regulatory en...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Aegerion Pharmaceuticals Cholesterol Genzyme HDL Isis Pharmaceuticals Juxtapid Kynamro LDL Lipitor Orphan Drugs Sanofi Source Type: blogs