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March 5, 2014
07:14 EDTKMDAKamada initiates Glassia Phase 2/3 clinical trial
Kamada announced the initiation of a Phase 2/3 clinical trial of Glassia. This double-blind, placebo-controlled, multicenter Phase 2/3 clinical trial of 190 pediatric patients with newly diagnosed T1D will evaluate the safety and efficacy of intravenous Glassia to halt disease progression and maintain the ability of the pancreas to produce insulin. This two-year study follows U.S. Food and Drug Administration and European Medicines Agency guidelines for clinical trials evaluating beta cell preservation and will measure C-peptide parameters HbA1C, hypoglycemic events and insulin daily dose, among others. Interim data are expected after approximately 90 patients complete one year of treatment, which will be in approximately two years. Initially, the trial will be conducted at four pediatric T1D medical centers in Israel with plans to expand the scope of the trial to include centers in other countries. Kamada previously reported positive preliminary data from the extension portion of its Phase 1/2 clinical trial of Glassia. That preliminary data showed that at approximately 20 months from diagnosis and approximately 10 months following the last Glassia infusion, 60% of study subjects who participated in the extension portion of the trial had peak C-peptide levels greater than 0.2 pmol/ml, which indicates a functioning beta cell capacity and is considered to be a higher percentage than would be expected without intervention.
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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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