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Enlivex Granted EU Orphan Drug Designation for Lead Product ApoCell for Graft-versus-Host Disease

Jan. 26, 2015

Enlivex Granted EU Orphan Drug Designation for Lead Product ApoCell for Graft-versus-Host Disease


Jerusalem, Israel – January 26, 2015 – Enlivex Therapeutics (Enlivex), a Hadasit Bio-Holdings (HBL, TASE: HDST / OTCQB: HDASY) portfolio company, today announced that the European Medicines Agency (“EMA”) has granted orphan drug status to the Company’s lead product candidate, ApoCell, for the prevention of Graft-versus-host Disease (GvHD). Previously, ApoCell received orphan drug designation from the U.S. Food & Drug Administration (FDA). The Company plans to initiate a Phase IIb / III trial of ApoCell in GvHD in 2015.


“The EMA’s orphan drug designation of ApoCell is a significant step forward in our clinical program. GvHD is a serious complication that affects 30% - 70% of bone marrow transplant patients and a substantial contributor to transplant-related morbidity and mortality,” said Alon Moran, CEO of Enlivex.  “With orphan status now secured in both Europe and the United States, we believe that we are well positioned to advance the development of the product and address the significant unmet medical need arising from the current absence of effective GvHD treatments.”


GvHD is a complication of allogenic (donor-based) bone marrow and stem cell transplants in which the newly transplanted cells recognize the recipient as foreign and attack the body. GvHD can damage organs including the liver, skin and digestive tract. With no effective cure for GvHD currently available, the most common therapy is Immunosuppression, including steroid treatment, which can significantly increase the patient’s risk of severe infection.


Tami Kfir, CEO of Hadasit Bio-Holdings added, “We are extremely pleased with the progress that Enlivex has made since Professor Mevorach first discovered the ApoCell technology, including the receipt of orphan drug status in the United States in 2013. With compelling Phase I/II data, which demonstrated a significant reduction in acute (grade II – IV) GvHD in patients treated with ApoCell, we believe that ApoCell has great potential in the GvHD market, which is projected to reach $600 million in 2018. In addition to extended market exclusivity, this orphan drug designation could accelerate the EMA regulatory process and significantly reduce time-to-market for ApoCell in Europe. We look forward to sharing details of future Enlivex milestones in the ongoing GvHD development program and other autoimmune and inflammatory indications.”


Administered by the EMA’s Committee for Orphan Medicinal Products, orphan drug designation is granted to products intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease with a prevalence in the EU of no more than 5 in 10,000, with no satisfactory method of diagnosis, prevention or treatment authorized by the EMA. Products that receive orphan designation benefit from a number of incentives, including protocol assistance and 10-year market exclusivity following regulatory approval.



About Enlivex:

Enlivex is a developer of immunotherapy treatments, including autologous and allogeneic cell therapy solutions for autoimmune and inflammatory conditions byinducing immune tolerance. The Company is preparing to initiate a Phase IIb / III trial of its lead product candidate, ApoCell, which has been granted orphan drug status by both the U.S. FDA and European EMA for the prevention of graft-versus-host disease (GvHD). The Company plans to initiate a Phase II trial of ApoCell in additional autoimmune and inflammatory indications.


About HBL:

Hadasit Bio-Holdings Ltd. ("HBL") is a publicly-traded holding Company (TASE: HDST / OTCQB: HDASY) focused on identifying and making strategic investments in promising, early-stage life sciences companies.


Through its longstanding partnership with Hadassah University Medical Center in Jerusalem, HBL is committed to driving the advancement of products and technologies developed at one of Israel’s foremost academic research hospitals. This relationship uniquely positions the Company as a public  gateway to the emerging Israeli biotech market.


The potential of HBL’s portfolio companies is underscored by the quality of its co-investors, which include Sanofi, CLAL Biotechnology Industries, Pontifax, TEVA and BioTime.


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