The Next Challenger to the EPO Monopoly

What exactly makes Affymax’s anemia drug candidate Hematide different from what’s currently being used to treat anemia associated with kidney disease?

Morris: In the renal area, which is our primary focus, we think the once-a-month product does have great advantages for patients not on dialysis. These are people that are still trying to have very active lives, raising families and have jobs. If they are older and retired, they still have other things they want to do instead of trek to the doctor two to three times a week to have an injection of their ESA.. The fact it isn’t a protein is also important because we thought this would be a much simpler product to make. It is a pegylated product, so there is no sequence homology to EPO. Its immunogenicity is extremely low with this product, and it doesn’t produce PRCA. It actually corrects PRCA. We have evidence in humans now that it can actually correct that condition. So from a safety perspective, we think that’s also important. It gives very predictable hemoglobin control, so if you are giving the product once a month, we also think that could be important in comparison to a product being given two to three or more times a week, particularly in the dialysis center. Now, you’re not going to have the desire to tinker with the dosing. We’re hoping that when we see our Phase 3 data that will show much more predictable hemoglobin control because you’re not trying to change the dose to match more fluctuation in hemoglobin. There is evidence in the literature that can produce cycling. We’re hoping, when we see our data that might be an advantage. It’s a room-temperature stable product, so it can be shipped and stored at room temperature, we believe. We’re still collecting the data on that.

Could any patent issues arise with Hematide?

Morris: We have no sequence homology at all to EPO. So our little peptide is not a piece of EPO; it’s a completely novel sequence that could not be predicted or taught by any of the intellectual property around the proteins. There’s not an issue. It’s a novel compound, and it has very strong patent protection.