Affymax faces extinction after Omontys debacle
Affymax has taken the scythe to three quarters of its workforce and is now looking the Grim Reaper firmly in the eye – or at least eye socket – itself. The recall of its only product, the anaemia drug Omontys, last month has hit the California company so hard that it is considering filing for bankruptcy.
The company has fired 230 employees in an attempt to focus its operations on the ongoing investigation of five cases of fatal anaphylaxis reported in patients given Omontys. This is just the beginning: it says it is also looking into further cuts, sale of the company or its assets, or a corporate merger. Affymax's share price fell 57% to $1.25 in early trading today.
A graph of Affymax’s share price over the last month looks like a picture of the cliff at Beachy Head. The Omontys recall caused the company’s greatest ever fall, an 85% drop from $16.52 at close on February 22 to $2.42 on February 25 (Spectre of Omontys safety concerns haunt Affymax again, February 25, 2013).
Less than two weeks later, the company enjoyed its greatest ever share price rise, jumping 54% on March 7 thanks to nebulous – and, it turned out, entirely false – rumours that Fresenius Medical Care, one of the main customers for Omontys, was open to the possibility of the product returning to market.
Omontys was approved just under a year ago with a narrower label than Affymax had sought (Affymax's fight begins as Epogen contender finally wins approval, March 28, 2012). The label also carried a black box warning, but interestingly this did not concern anaphylaxis or any sort of immune response, instead focusing on cardiovascular risks including heart attack, stroke and thrombosis.
Out of time and out of luck
This is not necessarily the end of the road for Omontys. If the investigation into the adverse events attributes them to something other than the molecule itself, such as an error in manufacture or a problem with a particular formulation, it could re-enter the market.
This could be of some comfort to Affymax’s partner, Takeda, which being far larger and more diverse is better placed to weather the storm – though the farrago does little to enhance the Japanese group’s reputation as a deal-maker. Takeda will now take over the investigation into Omontys as Affymax says it may not have the resources to see it through.
It could be months or years before the drug is deemed safe, if indeed it ever is. And for Affymax, any resurrection of Omontys will almost certainly come too late.
If, however, the hypersensitivity reactions are tied to the Omontys peptide, the consequences could affect more than just Affymax and Takeda. The peptide, called peginesatide generically, is a tweaked version of erythropoietin, and if the tweaks are found to be the cause of the patient deaths the consequences for biosimilars and their developers could be dire.