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Tuesday, August 06, 2019 10:29:56 PM
I think most people familiar with new drug launches would say that the Xyosted launch is going very well so far, and probably better than many expected. I don’t worry about the weekly prescription slowdown. It’s still very early, and prescription data early in a new launch tend to be lumpy week to week, so the four week moving average is a better way to see the trend, and so far, it’s still positive.
Competition from the pills is going to happen at some point. Lipocine has been denied both times they applied for approval, and the most recent CRL listed numerous deficiencies, so approval in November is far from certain. (I’d say odds are 50/50) Even if their NDA gets approved, Tlando has to be taken two or three times a day with a 800-1000 calorie intake. There are potential patient compliance issues, and many physicians may be reluctant to even prescribe this for some patients. In addition, Lipocine is a tiny clinical-stage company with no marketing or commercial infrastructure, or experience navigating formulary and insurance hurdles encountered when launching a new drug, so unless they find a good partner, they may have a very slow launch.
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