Navigation Links
Hadasit Bio-Holdings Flagship Portfolio Company Enlivex Awarded Orphan Drug Status for ApoCell Treatment by the FDA

JERUSALEM, April 4, 2013 /PRNewswire/ -- Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, announced today that one of its flagship portfolio companies, Enlivex Therapeutics, was awarded orphan drug status by the FDA for its ApoCell treatment.  The orphan drug designation provides for seven years of exclusivity, guaranteeing no competition irrespective of patents and significant regulatory relief, which will likely shorten the marketing approval of the drug in the US and reduce costs.

The ApoCell treatment is based on inducing immune tolerance and preventing Graft-versus-Host Disease (GVHD), which affects up to 70% of heterologous bone marrow transplant recipients and can be lethal.

Enlivex CEO, Alon Moran , commented, "The results from our Phase I/II clinical trials showed safety as well as an impressive indication of efficacy using our ApoCell treatment, which reduced severe GVHD complications in heterologous bone marrow transplant recipients. We intend to pursue the development of the drug through full marketing approval in the US."

GVHD affects 30,000 people annually in the US and Europe.  GVHD is an autoimmune disease in which the immune system of the new transplant attacks the patient's organs, primarily the liver, intestines and skin.  The disease can cause significant morbidity and is usually fatal if a patient reaches high grades.  To date, no effective treatment has been found for this disease.  The treatments that do exist are based on suppressing the immune system in order to decrease the attack on the patient's organs, but this process weakens the body and exposes it to other diseases.  The ApoCell treatment, on the other hand, is based 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:

For more information about Hadasit Bio-Holdings please visit:

KCSA Strategic Communications
Phil Carlson / Josh Dver
212-896-1233 / 1239 /

SOURCE Hadasit Bio-Holdings Ltd.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Hadasit Bio-Holdings Portfolio Companies Receive Funding to Support Clinical Trial Preparations and Obtain Regulatory Approvals in U.S. and Europe
2. Projecis Demonstrates Flagship Project Management Software at Outsourcing Clinical Trials-West in San Francisco
3. TPI Provides Further Updates on its GMOL Flagship Product
4. Alliqua Initiates Life-Cycle Management Plan to Expand Wound Care Portfolio for Use in Broader Wound Indications
5. Emerging Data From Upsher-Smiths CNS Portfolio Highlighted At 2013 American Academy Of Neurology Meeting
6. SAFC Expands PharmaGrade Raw Materials Portfolio to Meet Growing Demand; Expects to Double PharmaGrade Portfolio in 2013
7. Amedica Expands Patent Portfolio with Proprietary Silicon Nitride Total Disc Implant to Treat Neck and Back Pain
8. Mylan Launches Innovative Portfolio of Antiretroviral Products for Treatment of HIV/AIDS in South Africa
9. Unilife to Showcase Broad Portfolio of Innovative, Differentiated Injectable Drug Delivery Systems at Pharmapack Europe
10. Ferring Pharmaceuticals Inc. Recognized for Best-in-Class Work-Life Portfolio
11. Elekta to Showcase Broad Portfolio of Cancer Management Solutions at 2013 Arab Health Congress and Exhibition
Post Your Comments:
(Date:11/26/2015)... Research and Markets ( ) has announced ... Outlook to 2019 - Rise in Cardiac Disorders and Growing ... to their offering. Boston ... scientific and others. --> The market ... Boston scientific and others. ...
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... Global Cell Surface Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... European Therapeutic Drug Monitoring (TDM) Market: ... Intelligence, Emerging Opportunities"  report to their ... has announced the addition of the  ...
Breaking Medicine Technology:
(Date:11/29/2015)... ... 30, 2015 , ... The Cyber Monday deal is a deep 40% or more discount on ... get gifts for the skin care lover in your circle. Each Christmas, Sublime Beauty ... year, the 3 serums are staples: Collagen, Retinol and Hyaluronic Serums. , Stocking stuffers like ...
(Date:11/29/2015)... (PRWEB) , ... November 29, 2015 , ... While conventional ... kneeling or provide ready access to exercise weights. Fortunately, an inventor from Uniontown, Pa., ... THE TOMMY WALKER to enhance the benefits of a standard walker to improve the ...
(Date:11/29/2015)... ... November 29, 2015 , ... Effective immediately, every single IguanaMed scrub style ... Black Friday Target is offering a “Buy One Scrub Set, Get the 2nd Scrub ... to purchase IguanaMed at a discounted price. , IguanaMed’s mission is to ...
(Date:11/28/2015)... , ... November 28, 2015 , ... Safe storage for ... of two inventors, one from Lakewood, New Jersey and the other from Bradley Beach, ... patent-pending PROTECTOR to save the expense of having to replace NuvaRings more often than ...
(Date:11/28/2015)... ... , ... Pixel Film Studios is back again with ProPanel: Pulse . ... endless. Users have full control over angle of view, speed method, start point, end ... to get heads to turn. , ProPanel: Pulse offers fully customizable pulsating shape masks, ...
Breaking Medicine News(10 mins):