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March 4, 2014
08:03 EDTKMDAKamada completes enrollment in KamRAB U.S. clinical trial
Kamada announced that it has completed enrollment in its U.S. Phase 2/3 clinical trial of KamRAB as a post-exposure prophylaxis for rabies. Kamada has a strategic agreement with Kedrion for the clinical development and marketing of KamRAB in the U.S. The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies. The primary and secondary endpoints of this study are pharmacokinetic parameters of anti-rabies IgG levels in serum at different time points. In addition, safety and tolerability are assessed. The company said, "We look forward to completing this pivotal study in the coming months and, pending a favorable outcome, to filing a submission for approval with the FDA thereafter.”
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September 29, 2014
06:36 EDTKMDAKamada announces second extension of strategic agreement with Baxter
Kamada (KMDA) announced the second extension to supply Glassia to Baxter (BAX) in its strategic agreement with the biopharmaceutical business of Baxter. Through the extended agreement, Kamada secured $26M in additional revenues of Glassia, the company’s proprietary, ready-to-infuse liquid alpha-1 antitrypsin treatment that is indicated as a chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency, through 2017. As a result, Kamada expects that total revenue generated through this agreement from October 2010 through end of 2017 will increase to a minimum of $191M compared with a minimum of $110M contained in the original agreement executed in 2010 and a minimum of $165M contained in the May 2013 extension. In addition, the company reports that the supply of Glassia to Baxter has been extended through 2017 and that the transition to royalty payments for Glassia produced by Baxter is not expected to begin before 2018. Until that time, Kamada will continue to produce Glassia for distribution by Baxter. Kamada is confident in its ability to support the increased demand from Baxter throughout the term of the amended agreement.

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