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» Incyte's CEO Discusses Q1 2012 Results - Earnings Call Transcript
Drug has worked extremely well in myeloproliferative neoplasm called myelofibrosis of which there were about 18,000 known patients in the United States. It treats the very debilitating symptoms of the disease and also as part of that shrinks the very large spleens that many of these patients get. There is accumulating data that shows that the drug may well prolong survival, although we don’t have that in the label. And the drug was approved for use in intermediate and high-risk patients which comprise about 85% of that 18,000, and without any restriction on platelet count, despite the fact that we had only studied patients with platelet counts above 100,000 in our Phase III studies.So the approval was towards the end of last year, and our revenue is growing in a steady and sustained way. And we are getting reports back from the field and from physicians that they are seeing pretty dramatic effects which is the same thing we saw in the Phase III studies. I’m sure you don’t want to get more specific about some aspects of that, but in general that’s kind of the story. David Friedman – Morgan Stanley & Co. LLC Great. And so, maybe if we can just jump into the types of patients that have come on drug to date and it’s only been a couple of quarters. But if you can talk about just in the general sense the types of patients that you saw coming on drug in the first couple of months versus the contrast of the types of people you’ve seen come on drug in the past couple of months. Paul A. Friedman Sure, but I think that is important to note. So the beauty of the label was we did not get a restriction for platelet count. The difficulty with the label that we’re dealing with aggressively is that without a limitation on platelet count, we saw in the beginning of our launch a very high proportion of the sicker patients who are too sick to get into our clinical trials that is patients with platelet counts less than 100,000. I mean over 60% of the patients who came in early in launch had platelet count in that range.
The two doses in the label are 15 milligrams and 20 milligrams twice a day, which were quite well for people who have platelet counts above 100,000 and we are challenging for people with platelet counts below 100,000. Because one of the major reversible side effects of using the drug are myelosuppression both decrease in platelet count and decrease in red count, although that latter is a somewhat transient phenomenon because there are recovery mechanisms that occur while you are still on the drug. So the platelet count early on can go down, it goes down below a certain level patients have to discontinue the drug.And we have – since launched on a very nice study in low platelet count patients where we start them on a lower dose 5 milligrams twice a day and work up and we are finding that almost all of them can get to 10 milligrams BID and at that does they are getting essentially the same results on spleen reduction symptom relief that the less sick patients get at the higher doses and we put that in – we send that to the FDA for an update on the label and when requested we are obviously explaining that to physicians who might start a patient with low platelet count on the drug. But as you might expect those patients were sick, much significantly sicker than the patients that we are currently seeing coming to the group of people who are now getting the drug and who we studied in Phase III. So some of them died, some of them can't tolerate the higher doses, so early on the discontinuation rate was higher. It seems to be modulating. Read the rest of this transcript for free on seekingalpha.com