Kamada withdraws European marketing application for AATD candidate, another clinical trial needed; shares down 25% premarket
Jun. 22, 2017 7:53 AM ET|About: Kamada Ltd (KMDA)|By: Douglas W. House, SA News Editor
Kamada Ltd. (NASDAQ:KMDA) slumps 25% premarket on average volume in response to its announcement that it has withdrawn its marketing application in Europe seeking approval of its inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The company took action after the European Medicines Agency (EMA) indicated that more data are needed, specifically another clinical trial, before it will accept the filing for review. The EMA believed that the post-hoc data submitted by the company was insufficient to prove the efficacy of inhaled AAT.
Kamada is currently working with the U.S. FDA to secure approval to initiate a Phase 3 study that is expected to begin next year. It intends to use these results to support the resubmission of its European application.
CEO Amir London says, “While we are disappointed that the withdrawal of our MAA extends the timeline for the potential approval of inhaled AAT for AATD in Europe, we remain committed to the continued development of this product. Based on the successful U.S. Phase 2 study concluded late last year and the positive lung function data from the European Phase 2/3 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 3 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.”
