The Next Challenger to the EPO Monopoly

Is there a difference in administering Hematide intravenously vs. subcutaneously?

Knapp: The data we have so far lead us to believe the administration of Hematide IV and subcutaneous is equivalent. So there really wouldn’t need to be any dose adjustments if you went from one route to another, which we think, will prove to be valuable in the dialysis setting if, in fact, things like bundling come on board.

Can you explain the potential Hematide could have in treating pre-dialysis patients?

Morris: People can come in once a month to get their injections. Also, if they are going to be injecting themselves, which they do in Europe, it’s a room-temperature stable. You don’t have to worry about shaking it, dropping it, having it set out on the counter in a kitchen. It’s not a big deal. This drug is not going to produce pure red cell aplasia, and that’s also a potential advantage for these people that have to be on these drugs for a long period of time. PRCA is a very severe immunogenicity reaction. All the recombinant EPO drugs have the potential to  produce it, but most it was seen with the J&J drug marketed in Europe. Several hundred patients developed PRCA. It’s an antibody response to the drug that actually prevents EPO from working to stimulate red blood cell production. You basically stop making red blood cells and you become transfusion dependent. We’ve actually been able to treat those patients very well. It’s a risk you don’t have to take with our drug.

Have the black-box warnings the FDA placed on anemia drugs had any affect on Hematide’s development?

Morris: I would say in the renal area, absolutely not. Nephrologists are very aware of the issues in using these drugs and are very sophisticated about the selection and use of ESAs. We haven’t seen any issues in terms of the black box warning. The FDA requested that we  do this composite safety endpoint,. That’s the biggest change. Then the fact people have been lowering hemoglobin levels in patients to bring them more in line with the package inserts.

Knapp: We very specifically waited in the fall of last year until after the cardio-renal advisory board took place before we put our first patient in the trial. That was just part of our diligence in wanting to make sure we felt good about the design and the entry criteria.