Hadasit Bio Holdings Ltd. (TASE:HDST; Bulletin Board: HADSY) portfolio company Enlivex Therapeutics Ltd. (25.8%) has obtained orphan drug status from the European Medicines Agency (EMA) for its Apocell treatment for graft-versus-host disease (GVHD).
GVHD affects 70% of patients who receive bone marrow transplants from an unrelated donor, and can be lethal. The treatment already has orphan drug status from the US Food and Drug Administration (FDA). GVHD affects 30,000 people annually in the US and Europe. It is basically an autoimmune disease, in which the body's immune system attacks the implant as a foreign body.
There is no effective treatment for the disease. Current treatments involve suppressing the body's immune system, but this exposes patients to disease. Apocell induces tolerance in the patient's immune system by activating the natural cell death mechanism, apoptosis, immediately after a bone marrow transplant.
Hadasit Bio CEO Tami Kfir said, "Orphan drug status will promise marketing exclusivity for the drug for 10 years, which is a very real marketing advantage."
Hadasit Bio, a unit of Hadasit - the Technology Transfer Company of Hadassah Medical Organization , owns 25.8% of Enlivex. Hadasit Bio's share price rose 17.04% by early afternoon on the TASE. The share closed at $0.72 on the Bulletin Board yesterday, giving a market cap of $5.14 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 22, 2015
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