The Next Challenger to the EPO Monopoly

Editor's Note: The online version of this interview includes corrections from the print version due to transcription innacuracies.

At the 45th ERA-EDTA Congress in Stockholm, Palo-Alto, Calif.-basedAffymax presented preliminary data showing its anemia drug Hematide was well tolerated and maintained hemoglobin levels in patients on and not on dialysis. In the trials, the drug was administered once-a-month to patients, but perhaps more compelling, is that Hematide is nothing like the anemia drugs—Amgen’s Epogen and Aranesp—currently on the market and shouldn’t be KO’d by Amgen’s patents like other challengers. Renal Business Today recently spoke with Affymax president and CEO Arlene Morris and chief commercial officer Jeff Knapp to learn more about the company and its drug.

Given Amgen’s stranglehold on the anemia drug market, why did Affymax decided to throw its hat in the ring in developing Hematide?

Morris: We felt that we had a great opportunity when we discovered this peptide that had no sequence homology, whatsoever, to EPO. It’s not a protein, and we knew we could develop something that could be a true once-a-month product. We thought those would give us some very significant advantages over the products that were on the market, particularly the shorter-acting EPO alphas and Aranesp. To be able to provide a long-acting product that wasn’t a protein in the market would be great. From a business perspective, we liked it because we thought, not only did it have the opportunity to be a best-in-class profile, but it was a market that a small company could handle, as evidenced by the number of people both Amgen and J&J (Johnson & Johnson) had to put on this product in marketing and sales to be effective. It’s not a primary-care drug, so when we were looking at all the things we could work on from a business strategy perspective was important to us, and that we could actually be a renal company.

Knapp: This is a market that has been ready for a long time to have additional competition. From a corporate perspective and the stranglehold Amgen has had on the dialysis market for 18 years, we think it’s high time that new competition comes into the market. From a marketing perspective, we would love to be that next product in line to enter the dialysis space.