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:6/24/2016)... June 24, 2016  Collagen Matrix, Inc., ("Collagen ... and manufacturing of collagen and mineral based medical ... that Bill Messer has joined the ... further leverage the growing portfolio of oral surgery, ... Bill joins the Collagen Matrix executive team ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of ... award to iHire in recognition of their exemplary accomplishments in worksite health promotion. , ... Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, ... economy by obtaining investment capital for emerging technology companies. SCP has delivered ... already resulted in more than a million dollars of capital investment for five ...
Breaking Medicine News(10 mins):