Kamada Withdraws Inhaled AAT Marketing Application In EU

Kamada Ltd.’s (NASDAQ:KMDA) shares declined almost 16% after the company decided to withdraw the marketing authorization application (MAA) for its inhaled formulation of Alpha-1 Antitrypsin (AAT) in the EU.

The European Medicines Agency (EMA) concluded that the data submitted was insufficient for the approval and supplementary data will be required from additional clinical study.

The company was looking to get inhaled AAT for treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). Notably, AATD is a life-threatening orphan disease, occurring from deficiency of protein (AAT), derived from human plasma.

Kamada submitted MAA to EMA in March last year, based on data from post-hoc phase II/III European study that evaluated the safety and efficacy of inhaled formulation of AAT. Though the study has unable to meet its primary and secondary endpoints, it did demonstrate a statistically significant and clinically meaningful improvement in lung function.

Subsequently in Jan 2017, the company received a guidance from Committee for Medicinal Products for Human Use (CHMP) related to the design of phase II/III study and the regulatory pathway for the drug’s approval. Eventually, EMA concluded that the data submitted was insufficient for the approval and that supplementary data will be required from additional clinical study.

Notably, Kamada at present seeks approval for an investigational new drug (IND) application this year from FDA to conduct a phase III pivotal study of the inhaled AAT for curing AATD, beginning from 2018. The company also plans to utilize data from this study to resubmit a marketing application in the EU.

Shares of Kamada have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock rallied 15.6% ahead of the broader industry’s gain of 10.6%.



Kamada at present markets Glassia in the U.S. for the treatment of AATD. This ready-to-use, intravenous plasma-derived AAT product is the first and only liquid, approved by the FDA. Kamada markets Glassia in the U.S. through a strategic partnership with Shire plc (NASDAQ:SHPG) and in other countries via local distributors.

Apart from inhaled formulation of AAT, the company has four other late-stage plasma-derived protein products in developmental stage. We hope investors focus on the company’s update, related to its pipeline development going forward.

Zacks Rank & Key Picks

Kamada currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector are Bayer (DE:BAYGN) AG (OTC:BAYRY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . Each stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates inched up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 60 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.

Bayer’s earnings per share estimates increased from $8.75 to $8.86 for 2017 and from $9.41 to $9.53 for 2018, over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 10.25%.

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