Omontys Problems Likely Signal End for Drug Maker: Analysts

A recent report by an investment analysis site indicates that investors should not expect the recalled anemia drug Omontys to ever return to the market, suggesting that one of the manufacturers, Affymax, may be in trouble.  

On November 12, Seeking Alpha reported that data continues to shows how unsafe Omontys is, painting a “very grim picture for Omontys” from case narratives that show adverse reactions that resulted in death, despite prompt medical attention.

Omontys (peginesatide) is a relatively new anemia drug that was introduced by Affymax and Takeda Pharmaceuticals in April 2012. After it was approved, Omontys was primarily used at Fresenius dialysis centers as part of a pilot program.

Within months, reports of serious and sometimes fatal allergic reactions were linked to Omontys problems, typically occurring within 30 minutes of the first injection,

In February 2013, an Omontys recall was issued following at least five reports of death due to anaphylatic shock. However, a subsequent report by Seeking Alpha identified at least 22 Omontys deaths that may be related to the medication.

Following a review of additional details received from the FDA, Seeking Alpha predicts trouble for Affymax.

“The FDA data, combined with the lack of commentary about Omontys on Fresenius’ or Takeda’s latest earnings calls and the cash burn at Affymax, all lead us to believe that the end is near for Affymax,” according to the report.

Patients Died Quickly in Omontys Case Reports

According the Seeking Alpha review, case reports suggest frightening experiences by patients injected with Omontys before they died.

“At 13.17, 10 mg of Omontys was administered intravenously. Two minutes later, the patient shouted out that he was not feeling well,” one report states. “The patient stated “everything is gray” and he became unresponsive.”

“At 8:16 AM, the first dose of Omontys 15 mg IV was administered and 3 minutes later, at 8:19 AM, the patient complained of “burning all over” and developed shortness of breath,” according to another report. In that instance, the patient complained he could not breathe and was unresponsive less than 10 minutes later.

About 25,000 patients were exposed to the drug before the recall. However, adverse event reports submitted to the FDA typically only represent about 1% to 10% of all adverse events actually associated with prescription medications.

According to information previously released by Affymax and Takeda, the Omontys problems occurred in about 0.2% of cases, with about a third of those being serious and sometimes including anaphylaxis that requires prompt medical intervention and hospitalization. Fatal reactions occur in about 0.02% of all cases, according to the manufacturers.