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DUBLIN, Feb. 18, 2016 /PRNewswire/ — Jazz Pharmaceuticals plc JAZZ, -0.61% appear today that advisers will present three Jazz-sponsored articulate abstracts accompanying to the advancing appraisal of defibrotide, an investigational anesthetic actuality advised in the United States (U.S.) for the assay of developed and pediatric patients with hepatic veno-occlusive ache (VOD), additionally accepted as sinusoidal obstruction affection (SOS), with affirmation of multi-organ dysfunction (MOD) afterward hematopoietic stem-cell transplantation (HSCT). Data will be presented at the 2016 BMT (Bone Marrow Transplantation) Tandem Meeting, the accumulated anniversary affairs of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for All-embracing Blood and Marrow Transplant Assay (CIBMTR), demography abode from February 18 to 22 in Honolulu, Hawaii.
The three articulate accurate presentations include: 1) After-effects from the pivotal, historically controlled Phase 3 balloon of defibrotide for the assay of hepatic VOD, additionally accepted as SOS, with MOD afterward HSCT; 2) after-effects from a sub-analysis of abstracts from an open-label, randomized, Phase 3 pediatric balloon of defibrotide for the prophylaxis of VOD, including patients with specific VOD / SOS accident factors; and 3) after-effects from an basic post-hoc assay of abstracts from an broadcast admission assay of VOD / SOS abstraction to appraise the timing of defibrotide admission post-VOD assay and appulse on Day 100 adaptation afterward HSCT.
“The abstracts presented at this year’s BMT Tandem Meeting add to the growing anatomy of accurate affirmation apropos the adeptness and assurance of defibrotide in the assay of hepatic VOD with MOD afterward HSCT,” said Karen Smith, M.D., Ph.D., all-around arch of assay and development and arch medical administrator at Jazz Pharmaceuticals. “As we analyze added abeyant break for defibrotide, the added we know, the added we adeptness be able to do to ample unmet needs for patients.”
The two Phase 3 cardinal abstraction articulate presentations will booty abode on Thursday,February 18, 2016, from 4:45 to 5:15 pm Hawaii-Aleutian Standard Time (HAST) during Session A: Articulate Abstracts – Late Effects, Supportive Care and Quality of Life, in Exhibit Hall 3 at the Hawaii Convention Center:
The third articulate presentation will booty abode on Sunday,February 21 from 4:45 to 5:00 pmHAST during Session L: Articulate Abstracts – Late Effects, Supportive Care and Quality of Life, in allowance #316 ABC at the Hawaii Convention Center:
The 10 posters will be presented in the affiche sessions in Exhibit Hall 3 at the Hawaii Convention Center. The afterward will be presented on Thursday, February 18 from 6.45 to 7:45 pm HAST:
The afterward posters will be presented on Sunday, February 21 from 6:45 to 7:45 pm HAST:
The BMT Tandem Meeting is one of the better all-embracing forums committed accurately to HSCT.
Full capacity of the 2016 BMT Tandem Meeting can be begin at https://bmt.confex.com/tandem/2016/meetingapp.cgi/Home/0.
HSCT is a potentially alleviative action to amusement patients with cancerous and non-cancerous hematologic disorders such as leukemia, lymphoma and aplastic anemia, complete immunodeficiency and autoimmune disorders. [1 ] Hepatic VOD, additionally accepted as SOS, is a rare, aboriginal and life-threatening aggravation of HSCT. [2 ]
In the U.S., defibrotide is an investigational biologic for the assay of patients with hepatic VOD with MOD afterward HSCT. Defibrotide was accepted Orphan Biologic Appellation by the FDA in May 2003 and has Fast Track designation. A new biologic appliance (NDA) is beneath analysis by the U.S. Food and Biologic Administration (FDA).
Defibrotide is actuality fabricated accessible as an investigational new biologic (IND) chargeless of allegation through an broadcast admission Assay Protocol. The advancing broadcast admission Assay Protocol is currently enrolling patients diagnosed with VOD in the U.S. Broadcast admission programs are allotment of an accomplishment by the FDA and the biologic industry to accomplish investigational drugs accessible for the assay of austere or life-threatening diseases in bodies with bound assay options. For advice about the broadcast admission defibrotide study, contact Erin Tokunaga at [email protected] or Lam Calderon (1.312.706.6240; [email protected]); or visit www.clinicaltrials.gov (identifier:NCT00628498).
In Europe, defibrotide is marketed beneath the name Defitelio®▼(defibrotide). In October 2013, the European Commission granted business allotment to Defitelio beneath aberrant affairs for the assay of astringent hepatic VOD in patients adeptness HSCT therapy. Defitelio accustomed an approval in Israel in May 2015 for the aforementioned adumbration as in the EU.
▼This alleviative artefact is accountable to added monitoring. This will acquiesce quick identification of new assurance information. Healthcare professionals are asked to abode any doubtable adverse reactions via the civic advertisement arrangement begin beneath area 4.8 of the SmPC (http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002393/human_med_001646.jsp).
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc JAZZ, -0.61% is an all-embracing biopharmaceutical aggregation focused on convalescent patients’ lives by identifying, developing and commercializing allusive articles that abode unmet medical needs. The aggregation has a assorted portfolio of articles and artefact candidates with a focus in the areas of beddy-bye and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) articulate band-aid and Erwinaze® (asparaginase Erwinia chrysanthemi) in the U.S., and markets Erwinase® and Defitelio® (defibrotide) in countries alfresco the U.S. For added information, amuse visit www.jazzpharmaceuticals.com.
“Safe Harbor” Statement beneath the Private Securities Litigation Reform Act of 1995
This columnist absolution contains advanced statements, including, but not bound to, statements accompanying to Jazz Pharmaceuticals’ development activities with account to defibrotide and added statements that are not absolute facts. These advanced statements are based on the company’s accepted plans, objectives, estimates, expectations and intentions, and inherently absorb cogent risks and uncertainties. Absolute after-effects and the timing of contest could alter materially from those advancing in such advanced statements as a aftereffect of these risks and uncertainties, which include, amid others, risks and uncertainties associated with the adversity and ambiguity of biologic artefact development and the ambiguity of analytic success; the ambiguity associated with the authoritative approval process; the company’s adeptness to finer commercialize its artefact candidates; and added risks and uncertainties affecting the company, including those declared from time to time beneath the explanation “Risk Factors” and abroad in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and letters (Commission File No. 001-33500), including the company’s Quarterly Abode on Form 10-Q for the division concluded September 30, 2015 and approaching filings and letters by the company. Added risks and uncertainties of which the aggregation is not currently acquainted may additionally affect the company’s advanced statements and may account absolute after-effects and timing of contest to alter materially from those anticipated. The advanced statements herein are fabricated alone as of the date hereof or as of the dates adumbrated in the advanced statements, alike if they are afterwards fabricated accessible by the aggregation on its website or otherwise. The aggregation undertakes no obligation to amend or supplement any advanced statements to reflect absolute results, new information, approaching events, changes in its expectations or added affairs that abide afterwards the date as of which the advanced statements were made.
References  Ikehara S. New strategies for BMT and agency transplantation. Int J Hematol. 2002;76(Suppl 1):161-4.  Coppell JA, Richardson PG, Soiffer R, et al. Hepatic veno-occlusive ache afterward axis corpuscle transplantation: incidence, analytic course, and outcome. Biol Blood Marrow Transplant. 2010;16(2):157-168.
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SOURCE Jazz Pharmaceuticals plc
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