Takeda and Affymax's highly anticipated EPO, Omontys (hematide; peginasetide) is the latest EPO to be hit by bad news. Omontys launched in the US in April 2012 for chronic kidney disease patients on dialysis, but on February 24th 2013, the companies recalled the drug from the US market following reports of serious hypersensitivity reactions and deaths. Omontys is a third-generation ESA with a unique amino acid sequence compared to traditional ESAs such as its major competitor, Epogen.
Drugs in the ESA class have been negatively impacted by associations with serious adverse cardiovascular events, so Omontys, deemed to have a safer side effect profile and dosing schedule (monthly) than existing ESAs (weekly), was welcomed by the dialysis community. This recent development comes as a surprise as hypersensitivities were not a recorded issue in clinical trials. Furthermore, the cases of hypersensitivities were all reported within 30 minutes of the first dose. The reasons behind these reactions are not currently clear but Takeda and Affymax are investigating possible causes and explanations and we await any updates.
Decision Resource's Pharmaview forecast for Omontys was conservative ($394m in 2018) due to the dominance of Epogen, the saturated ESA market, and general negative sentiments surrounding EPOs. However, this news is still a big blow to Takeda, which was looking to scale up its hematology division. The drug is being considered for approval by the EMA and we would expect the recent developments in the US to affect the decision in this region.
In 2011, Takeda announced it will not commercialize Omontys in Japan but would instead find a marketing partner in this region. For now, the future of Omontys looks bleak, and any sales from March 2013 are highly unlikely. We therefore expect a sharp downturn in sales and do not expect the drug to come back on the market. Even if it does, we believe the drug's association with hypersensitivity reactions and deaths, will cause physicians and patients to be wary, and could tarnish the brand permanently.