Kamada Gets Orphan Drug Designation For Glassia - Quick Facts

(RTTNews) - Israel-based Kamada Ltd. (KMDA) said Wednesday that the U.S. Food and Drug Administration or FDA's Office of Orphan Products Development has granted orphan drug designation for Glassia, the company's proprietary human Alpha-1 Antitrypsin, to treat Graft-versus-host-disease or GVHD.

Kamada noted that Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.

Glassia is Kamada's proprietary, ready-to-infuse liquid alpha-1 antitrypsin or AAT used for the treatment of chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency.

Currently, Glassia is being used in a Phase 1/2 clinical study that is being conducted by the Fred Hutchinson Cancer Research Center in Seattle, Washington in cooperation with Baxter International Inc. and Kamada.

The Phase 1/2 study is evaluating 24 GVHD patients with inadequate response to steroid treatment following allogeneic bone-marrow stem cell transplant. The patients are enrolled into 4 dose cohorts, in which they receive up to 8 doses of Glassia. Interim data from this study is expected by the end of this year.