Kamada withdraws from EMA its application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Kamada Ltd. a plasma-derived protein therapeutics company focused on orphan indications, announced that the Company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) with the European Medicines Agency (EMA).Following extensive discussions with the EMA during recent months, Kamada concluded that the EMA does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial.

While the post-hoc data provided by the Company from the European clinical trial showed a statistically significant and clinically meaningful improvement in lung function, the EMA was of the opinion that an overall positive conclusion on the effect of inhaled AAT to treat AATD could not be reached based on that post-hoc analysis, and that the treatment of AATD patients with inhaled AAT should be further evaluated in the clinic in order to obtain comprehensive long-term efficacy and safety data.

Kamada is currently in advanced discussions with the FDA in order to secure the approval of an Investigational New Drug (IND) application this year to conduct a U.S. Phase III pivotal study of inhaled AAT for the treatment of AATD that would begin in 2018. Kamada intends to utilize the data to be obtained from that pivotal study to resubmit the MAA to the EMA. Kamada will continue discussions with the EMA regarding the required data that would support the approval of the Company�s MAA.