(Corrects first paragraph to say drug is administered once-monthly)
* Hematide raised hemoglobin levels
* Side effects included hypertension, blood clots
By Deena Beasley
LOS ANGELES, Oct 30 (Reuters) - Affymax Inc AFFY.O and Takeda Pharmaceutical Co Ltd (4502.T) said early results from a mid-stage trial showed that their once-monthly drug Hematide increased hemoglobin levels in anemic kidney dialysis patients as well as Epogen, which is given three times a week.
The results, the first from a controlled trial of Hematide, were presented on Friday at a meeting of the American Society of Nephrology in San Diego.
Preliminary results from 114 patients showed that Hematide increased hemoglobin levels and maintained them within a target range of 11 grams/deciliter to 12 g/dL. After twelve weeks, “patients in the Hematide group appeared to show treatment results comparable to patients in the EPO group,” Affymax said in a statement.
Adverse events included thrombosis and vitreous hemorrhage. Affymax said a single serious side effect considered treatment-related was a case of arteriovenous fistula thrombosis that occurred with the lowest dose of Hematide.
Hypertension was the only treatment related adverse event that occurred in more than one patient — 8 percent of the low-dose Hematide group, 3 percent of the high-dose group and 8 percent of the Epogen group, the company said.
Results from four pivotal-stage trials comparing Hematide to Epogen or once-weekly Aranesp, both sold by Amgen Inc (AMGN.O), in patients with chronic renal failure are expected in the second quarter of next year.
Hematide, a synthetic drug that would compete with biologic anemia medicines that have faced restrictions over safety and potential overuse concerns but still register sales in the billions, is administered just once a month.
As the U.S. government’s Medicare program gets set to tighten reimbursement requirements for anemia drugs used by dialysis patients, “having a drug that is easier to administer may represent an advantage vs. a more labor intensive approach,” said Dr. Anne-Marie Duliege, chief medical officer at Affymax.
The company still plans to file for regulatory approval of Hematide in the second half of 2010, she said. (Reporting by Deena Beasley, editing by Matthew Lewis)