Takeda confirmed today it was ending its partnership with Affymax over troubled anaemia treatment Omontys, which was linked to several deaths last year.
The Japanese pharma company was forced to recall several lots of Omontys (peginasetide) in the US after reports of serious hypersensitivity reactions – including anaphylaxis – and as a result withdrew its marketing application for the drug in the EU.
Takeda now says it has concluded a “detailed investigation of these reactions [which] confirmed no quality or manufacturing issues were present.”
The probe was unable to identify a root cause for the adverse reactions, suggesting the problem may have originated from the drug itself and not some quality defect that could perhaps have been addressed and allowed Omontys to remain on the market.
As a result, Takeda says it will now withdraw its US marketing application for Omontys, as Affymax has indicated it would not take over rights to the drug.
Omontys was originally approved for the treatment of anaemia in adult patients with chronic kidney disease in March 2012 and was tipped as a challenger to Amgen’s anaemia franchise, represented by Epogen (epoetin alfa) and long-acting follow-up Aranesp (darbepoetin alfa). Prior to the side effect issues the drug had been predicted to make upwards of $500m a year in peak sales.
For Affymax, taking over Omontys was never a realistic option, even if Takeda had found a ‘fixable’ problem that could have rescued the US firm’s only-marketed product.
Affymax slashed 75 per cent of its workforce as news of the recalls came in last year, and by the end of March was down to three employees, with the firm running a deficit of almost $560m.
Meanwhile, Takeda has had a bad run of luck with its late-stage pipeline of late, dropping diabetes candidate fasiglifam earlier this year.
However, the company’s Entyvio (vedolizumab) has received approvals this year in both the EU and US for use in Crohn’s disease and ulcerative colitis.
This article was amended on June 18 to clarify the approvals of Entyvio