Kamada Ltd. (KMDA - Free Report) announced that the FDA has acknowledged the path forward for commencing a phase III study on the inhaled Alpha-1 Antitrypsin (Inhaled AAT) product, which is being developed for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
In 2016, Kamada’s phase II study on the inhaled AAT product for treating AATD in the United States met the primary endpoint. However, the FDA expressed concerns about data from the European phase II/III study on the candidate, which was presented in April 2016.
In 2017, the FDA provided a guidance for further development of the candidate and requested a complete proposed study protocol for moving on to the phase III development. During the year, Kamada decided to withdraw the marketing authorization application (MAA) for its inhaled formulation of AAT in the EU.
Moreover, last April, the FDA issued a response letter, lending further direction on the proposed phase III study protocol for Inhaled AAT product. The regulatory body still had doubts related to the safety profile of the inhaled AAT.
However, the FDA presently issued a letter to the company, which stated that the inhaled AAT product has satisfactorily addressed all the grey areas, previously conveyed by the agency.
Following this acknowledgement from the FDA, Kamada plans to start a pivotal phase III study in the second half of 2019. However, the timing of the program will depend on the successful completion of a human factor study (HFS), which is scheduled to begin in the ongoing quarter. The HFS evaluation will assess the combination of Kamada’s inhaled AAT and PARI Pharma GmbH's eFlow nebulizer device.
The phase III study will evaluate the safety and efficacy of the inhaled AAT product in patients with AATD. The primary endpoint of the study will be to check the lung function measured by FEV1 while the secondary endpoints will be to observe the changes in lung density as gauged by CT densitometry.
Subsequently, Kamada expects to file an investigational new drug (IND) application in the United States and a Clinical Trial Authorization (CTA) in Europe to initiate the pivotal phase III study on the inhaled AAT product for registration thereafter. If successful, the company plans to use the outcomes from this study to resubmit an MAA in the EU and file a biologics license application (BLA) to the FDA.
Shares of Kamada have surged 31.8% so far this year against the industry’s decline of 12.3%.
We would like to remind investors that Kamada currently markets its flagship product Glassia in the United States for the treatment of AATD. This ready-to-use, intravenous plasma-derived AAT product is the first and the only liquid, approved by the FDA. The company has a partnership agreement with Takeda Pharmaceutical (TAK - Free Report) , which is the sole distributor of Glassia in the United States, Canada, Australia and New Zealand.
Zacks Rank & Other Key Picks
Kamada currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks from the healthcare sector include Merus N.V. (MRUS - Free Report) and PDL BioPharma, Inc. (PDLI - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Merus’ loss per share estimates have been narrowed 28% for 2019 and 30.7% for 2020 over the past 60 days. The stock has rallied 17.8% year to date.
PDL BioPharma’s earnings estimates have been revised 100% upward for 2019 and 30% for 2020 over the past 60 days. The stock has gained 27.2% year to date.
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