The Next Challenger to the EPO Monopoly

How has Hematide been performing in its clinical trials, and what are the next steps to its approval?

Morris: We conducted a very comprehensive Phase 1 and Phase 2 program. We wanted to understand the profile of the drug, both in terms of how it performed from an efficacy perspective and to get a preliminary of its safety. So we conducted a fairly significant program with over 400 patients to understand the profile in the renal area. We have data in dialysis patients as well as in patients not on dialysis to show that the drug performs really well in both circumstances. So if you look at patients that are on dialysis, the trials we conducted were “switch” trials. These are patients were very well stabilized on EPO alfa, and we able to switch them from injections three times a week to a once-a-month injection of Hematide and maintain their hemoglobins between targets of 10 and 12 very nicely. In the non-dialysis patients, who were ESA naïve, we were correcting them into a range between 11 and 12 in the Phase 2 program. We were to correct them with two different doses—a lower dose and a higher dose. With both doses, we were able to get patients to respond very well.. The difference is the lower dose takes longer to get people into the target hemoglobin range. For both of those patient groups, it looked like a very effective therapy and could be given to everybody once a month, unlike something like Mircera, which has to be started every two weeks. And once a patient is stabilized over several months, then you switch them to once a month. Our drug is once a month for everybody under all conditions, so once you begin therapy, you begin it a once-a-month interval and you don’t have to be tinkering with it. From a safety perspective, we didn’t see anything unusual. The side effects were those that were consistent with the class.

Knapp: We expect to complete accrual of the Phase 3 program by the end of 2008. We will then follow those patients, most likely, until the end of 2009. We expect to submit to the FDA in 2010, and if the plan stays where we expect it to, we will be coming into the market sometime in 2011.