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Hadasit Bio-Holdings Flagship Portfolio Company Enlivex Awarded Orphan Drug Status for ApoCell Treatment by the FDA
Date:4/4/2013

d on normal biological activity and initiates a state of immune tolerance.  This mechanism is naturally called into action by the body when removing cells that are in the process of programmed cell death (apoptosis).  ApoCell launches this mechanism into action during the window of opportunity for treatment, close to the time of the bone marrow transplant.

"Receiving orphan drug status from the FDA is an important regulatory recognition of the drug's necessity," said Ophir Shahaf , CEO Hadasit Bio-Holdings.  "The future development track of the drug is relatively short, and the company expects regulatory relief along with tax breaks as part of the approval of the drug's orphan status.  This approval paves the way for the continued advancement and clinical development of the drug, and towards entering the American market that is estimated to be in the hundreds of millions of dollars annually.  The exclusivity section provides assurance in protecting the product from competition, and the status as a whole instills an advantage in the regulatory process with the authorities, creating a significant competitive edge and building value for our shareholders."

For more information about Enlivex and ApoCell please visit: www.enlivexpharm.com

For more information about Hadasit Bio-Holdings please visit: www.hbl.co.il

Contact:
KCSA Strategic Communications
Phil Carlson / Josh Dver
212-896-1233 / 1239
pcarlson@kcsa.com / jdver@kcsa.com


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SOURCE Hadasit Bio-Holdings Ltd.
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