Two weeks after Shire punted rights to one of its therapies, Israel’s Kamada $KMDA says that it is yanking its marketing application at the EMA for its inhaled therapy for rare cases of Alpha-1 Antitrypsin Deficiency after concluding that regulators will want to see data from another trial before they consider hitting the green light.
Kamada provided post-hoc data to back its case on a statistically significant and clinically relevant improvement in lung function among patients, but European regulators weren’t buying it.
Kamada’s shares plunged 26% as the news spread.
The plan now is to push through a pivotal Phase III study in the US — the application is in — and then take that data back to the EMA while looking to field an application at the FDA as well.
It’s been a bad month for Kamada. On June 7 the biotech reported that Shire was hitting the brakes on a Phase II/III study of G1-AAT IV for the treatment of acute graft-versus-host disease and handing rights to the drug back to the biotech. Shire picked the program up in its Baxalta acquisition, gaining a drug that Baxter in-licensed back in 2010. And like a number of Baxalta programs, Shire — which has been prioritizing its pipeline plans — decided that it didn’t want it.
CEO Amir London, who plans to follow through on the Phase II/III punted by Shire, had this to say in a prepared statement today about the EMA move:
Based on the successful U.S. Phase II study concluded late last year and the positive lung function data from the European Phase II/III studies, we believe that inhaled AAT has the potential to be a safe and effective treatment for AATD, an area with significant unmet medical need. We appreciate the strong support we continue to receive from patients and clinicians, as well as the transparent discussions with the EMA, and look forward to moving ahead with a U.S. Phase III pivotal clinical trial, once approved, as expeditiously as possible, which would allow us to utilize the supplementary data to be obtained from that study in order to resubmit our MAA to the EMA at an appropriate time thereafter.
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