Kamada (KMDA) Withdrawal of European MAA for Inhaled Alpha-1 Antitrypsin for Treatment of Alpha-1 Antitrypsin Deficiency Disease

June 22, 2017 7:01 AM EDT
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Kamada Ltd. (NASDAQ: KMDA) today announced that the Company has withdrawn the Marketing Authorization Application (MAA) for its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency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 U.S. Food and Drug Administration (FDA) in order to secure the approval of an Investigational New Drug (IND) application this year to conduct a U.S. Phase 3 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. Based on the substantial data set obtained to date, the extensive discussions with the EMA and FDA, as well as key opinion leaders in AATD, Kamada has a strong understanding of the indication, the method of treatment with an inhaled product and the key regulatory guidelines.

“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,” said Amir London, Chief Executive Officer. “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.”

“Importantly, Kamada is the first and only company to date that has developed and completed a pivotal clinical program of an inhaled formulation of AAT for the treatment of this life-threatening orphan disease,” continued Mr. London. “We are confident that the significant clinical and regulatory experience we have gained during recent years in the development of our inhaled AAT positions us well to design and execute a successful clinical trial and bring this promising product to the market in both the US and EU.”



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