Now that the EMA has elbowed Novartis application for Xiidra off the table, the reverberations are being felt at Takeda.

The pharma giant noted early Monday that it will recognize a loss of $200 million for the current quarter after the news hit late last week that the European regulator had decided that the eye drug they sold to Novartis for $3.4 billion in cash and $1.9 billion in milestones hadnt made its case on efficacy. The drug has been marketed in the US now for 4 years, and Takeda picked it up in the $62 billion Shire buyout and then promptly sold it off to Novartis.

That decision at the EMA is hitting the $1.9 billion in potential sales milestones, now that the European market is off the table. The continental regulator was clearly unimpressed by the data for Xiidra, and became skeptical over the way the control arm was handled by Shire.

In explaining the withdrawal, the EMA noted:

The Agency considered that the effectiveness of Xiidra was not demonstrated across different symptoms of dry eye disease. Although some effect was seen in the reduction of eye dryness, the improvement was not considered clinically significant. In addition, although Xiidra was intended to be used in patients with more severe disease in whom artificial tears had not been sufficient in improving the condition, the Agency had some concerns about how these patients were to be selected, and noted that the studies had compared Xiidra with the vehicle, and had not used artificial tears in an optimal way. The Agency also noted that there were no data on the effect of long-term treatment with Xiidra despite eye dryness being a chronic (long-lasting) disease.

The drug, as Novartis explained, is designed to block the interaction between LFA-1 1 and ICAM-1 2, inhibiting T cell recruitment and activation and reducing pro-inflammatory cytokine release.

Original post:
Takeda takes a $200M hit after Novartis is forced to yank its marketing application for Xiidra - Endpoints News