Affymax shares fall to lowest point in over 3 years on anemia drug’s late-stage safety data

Drug safety data sends Affymax shares tumbling

NEW YORK — Shares of Affymax fell to their lowest point in more than three years on Monday after the company reported safety data from ongoing late-stage studies of its anemia drug candidate Hematide that alarmed investors.

THE SPARK: Affymax said Hematide proved as effective as currently prescribed drugs at treating anemia in patients with chronic kidney failure — the study’s main goal. But, a subgroup of patients, who were not on dialysis, experienced more heart-related side effects primarily driven by higher rates of death, unstable angina and irregular heart rhythm.

THE BIG PICTURE: Hematide is the company’s lead drug candidate and if approved, it would compete in an already competitive market. That market includes Amgen Inc.’s Aranesp.

THE ANALYSIS: Leerink Swann Research analyst Dr. Joshua Schimmer said Hematide’s regulatory and commercial prospects are “clouded” by some of the results in the latest studies. In a note to Amgen investors on Monday, he cited some mixed results on Hematide’s effectiveness, though the study met its key goals in that area. But, the safety results could be problematic, he said.

“Nephrologists with whom we have spoken prefer to gain experience with Hematide in the predialysis setting prior to switching their dialysis units over to Hematide, so these results present an incremental commercial hurdle and obvious regulatory concern,” he said.

SHARE ACTION: Down $15.14, or 65.8 percent, to $7.87 in morning trading. The stock traded as low as $7.76 earlier, marking the lowest point in more than three years.