posilies schreef op 21 februari 2018 20:57:
HAE and Ruconest expansion
Ruconest proves to be more cost effective (and less sensitive to weight fluctuations) in treating patients who are overweight - see the polish study on cost effectiveness.
As for Cinryze, my point was that the FDA has not approved Cinryze for treatment of acute attacks (only for prophylaxis) and shows no sign of doing so. So a drug that has both kinds of application approved would be unique in the market and therefore provide at least some kind of an advantage for sales, especially on the long run I think it could 'colonize' some of the market share that others now have.
Bottom line is Ruconest will sell. Talk to any physician in the space. I've sold in HAE and have spoken to many. Cinryze failures/breakthrough attacks, etc. will get Ruconest 10-15% of the market which is just fine. Not to mention the usage from physicians who just plain old like their Ruconest Rep.. This is sales.
Cinryze and other plasma based products have clear warnings regarding the risk for thromboembolic events, as well as the infectious disease risk. No thromboembolic events have been seen with recombinant Ruconest to date
Ruconest has some distinct selling points. Because it is made from the milk of transgenic rabbits in a closed environment, there is not the risk of transmission of a human disease. The other treatments, Berinert, Firazyr, (Cinryze) are made from human blood, so they can contain infectious agents (eg, viruses and, theoretically, the Creutzfeldt-Jakob disease)
Patients don't seem to develop a resistance over time while this can be an issue with competitors. Moreover, Ruconest is approved for use ages 13 and up while Firazyr is only used 18 years and up.
Because Ruconest can be self administered, the IV/SQ issue does not really make a difference. What is really going to make the difference is if Ruconest gets the prophylaxis approval that they are working on. That would allow for use of the same drug for prophylaxis and acute attacks. I expect it will outsell the competitors all hands down at that point. Its also more effective for people who are overweight, that's at least a significant part of the potential users here in the States.