CORRECTED - Affymax: Hematide comparable to Epogen in trial

Fri Oct 30, 2009 5:26pm EDT
 
[-] Text [+]
 (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)

 

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