Deadly Dialysis Injection Recall Implodes Affymax

Health and Healthcare

Published: February 25, 2013 8:15 am

Last Updated: February 25, 2013 8:16 am

Another big implosion is taking place in the world of biotech and biohealth. Affymax Inc. (NASDAQ: AFFY) and Takeda Pharmaceutical announced over the weekend that they are going to voluntarily recall all lots of the Omontys injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions.

The reaction cited was anaphylaxis, which can be life-threatening or fatal. The companies have worked actively with the U.S. Food and Drug Administration (FDA), which has indicated its agreement with this decision. The companies also have issued a letter to health care professionals indicating that no new or existing patients should receive Omontys.

Affymax said that fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. These serious hypersensitivity reactions occurred within 30 minutes after such administration of Omontys. The companies said that there have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session.

More than 25,000 patients have received Omontys in the postmarketing setting since the drug launched. On the rate:

The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization. The companies are actively investigating these cases.

The companies have said that dialysis organizations are instructed to discontinue use and that customers will be provided instructions on how to return the product to the manufacturer for a refund.

Affymax is truly imploding on the news. Shares are down 85% at $2.41, after closing at $16.52 against a prior 52-week range of $10.20 to $27.74. The market cap at Friday’s close was $614 million, so about $522 million worth of that market cap is gone now.

Affymax was only expected to have sales of $136.7 million for all of 2013 and was still expected to post a loss. Needless to say, that consensus revenue figure will be cratering shortly. This represents what appears to be an all-time low for Affymax shares.

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