JAZZ Jazz Pharmaceuticals plc

167.71
+1.9  (+1%)
Previous Close 165.81
Open 166.09
52 Week Low 86.88
52 Week High 167.31
Market Cap $9,343,795,946
Shares 55,714,006
Float 54,302,832
Enterprise Value $9,669,540,946
Volume 677,229
Av. Daily Volume 557,301
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Upcoming Catalysts

Drug Stage Catalyst Date
JZP-258
Idiopathic Hypersomnia
sNDA Filing
sNDA Filing
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Drug Pipeline

Drug Stage Notes
PF743 (JZP-458)
Acute lymphoblastic leukemia (ALL)
BLA Filing
BLA Filing
BLA filing announced December 21, 2020.
Lurbinectedin
Small cell lung cancer (SCLC)
Phase 3
Phase 3
Phase 3 trial did not meet overall survival endpoint - December 3, 2020.
Defibrotide
acute Graft-versus-Host-Disease (aGvHD)
Phase 2
Phase 2
Phase 2 data showed modest trend toward benefit.
JZP-385
Essential Tremor
Phase 2
Phase 2
Phase 2b trial to be initiated 1H 2021.
Defibrotide
VOD in high-risk patients following hematopoietic stem cell transplantation
Phase 3
Phase 3
Phase 3 trial stopped early due to lack of efficacy.
Xywav
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Approved
Approved
FDA Approval announced July 22, 2020.
Lurbinectedin
Small cell lung cancer (SCLC)
Approved
Approved
FDA Approval announced June 15, 2020.
Solriamfetol (JZP-110)
Excessive sleepiness associated with narcolepsy
Approved
Approved
FDA Approval announced March 20, 2019.
Defibrotide
CAR-T associated neurotoxicity in diffuse large B-cell lymphoma (DLBCL) patients
Phase 2
Phase 2
Phase 2 commencement of enrolment announced October 10, 2019.
Xyrem
Pediatric narcolepsy patients with cataplexy
Approved
Approved
FDA Approval announced October 26, 2018.
Vyxeos
Acute myeloid leukemia
Approved
Approved
Approval announced August 3, 2017.
JZP-110
Excessive sleepiness associated with obstructive sleep apnea
Phase 3
Phase 3
Phase 3 data released March 20, 2017 - primary endpoints met.
JZP-6
Fibromyalgia
Approved
Approved
CRL received October 11, 2010.

Latest News

  1. DUBLIN, Jan. 4, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the 39th Annual J.P. Morgan Healthcare Conference.

    Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, January 11, 2021 at 2:00 p.m. EST / 7:00 p.m. GMT

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.  Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

    An archive of the webcast will be available…

    DUBLIN, Jan. 4, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the 39th Annual J.P. Morgan Healthcare Conference.

    Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, January 11, 2021 at 2:00 p.m. EST / 7:00 p.m. GMT

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.  Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

    An archive of the webcast will be available following the presentation for at least one week on the Investors section of the company's website at www.jazzpharmaceuticals.com.

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options.  We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas.  Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors.  We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies.  Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.  For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Jazz Pharmaceuticals Contacts:





    Investors: 

    Kathee Littrell

    Vice President, Investor Relations

    Ireland +353 1 634 7887

    U.S. +1 650 496 2717

    Media:

    Jacqueline Kirby

    Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141

    U.S. +1 215 867 4910

     

    Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-participation-in-the-39th-annual-jp-morgan-healthcare-conference-301200431.html

    SOURCE Jazz Pharmaceuticals plc

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  2. DUBLIN, Dec. 21, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for JZP-458 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. 

    The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.

    "Given the urgent need for a reliable and high-quality recombinant asparaginase option for patients with hypersensitivity to E. coli-derived asparaginase, we are committed to bringing JZP-458 to market as quickly as possible and pleased to be initiating our BLA submission," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "Receiving a Fast Track designation for JZP-458 from the FDA in October 2019 and being able to submit the BLA under the RTOR program is significant, potentially allowing us to more quickly address patient need with a new asparaginase option."

    The company continues to plan for a mid-2021 launch of JZP-458 following completion of the BLA submission and FDA review and approval.

    An ongoing Phase 2/3 study is being conducted in collaboration with the Children's Oncology Group (COG) to evaluate JZP-458 as a potential treatment option for pediatric and adult patients with ALL or LBL who are hypersensitive to E. coli-derived asparaginases. Hypersensitivity reactions affect up to 30 percent of patients with ALL and LBL who are treated with E. coli-derived asparaginase.1

    About JZP-458

    JZP-458 is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. It is being developed for use as a component of a multi-agent chemotherapeutic regimen in the treatment of pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products. JZP-458 was granted Fast Track designation by the U.S. Food and Drug Administration in October 2019 for the treatment of this patient population.

    About Acute Lymphoblastic Leukemia

    Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4,5 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.6 The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the United States in 2019.6 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.7 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.8

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases - often with limited or no options.  We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

    This press release contains forward-looking statements, including, but not limited to, statements related to potentially addressing patient needs with a new asparaginase option, plans for a mid-2021 launch of JZP-458, plans for completing the BLA submission, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

    Media Contact:

    Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141         U.S. +1 215 867 4910

    Investor Contact:

    Kathee Littrell, Vice President, Investor Relations

    Ireland +353 1 634 7887         U.S. +1 650 496 2717

    References:

    1. Vrooman et al. Erwinia Asparaginase after Allergy to E. coli Asparaginase in Children with Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2010 February; 54(2): 199–205. doi:10.1002/pbc.22225.

    2. National Cancer Institute. Adult Acute Lymphoblastic Leukemia Treatment (PDQ®)–Patient Version. Available at www.cancer.gov/types/leukemia/patient/adult-all-treatment-pdq. Accessed December 3, 2019. 

    3. American Cancer Society. Key Statistics for Childhood Leukemia. Available at www.cancer.org/cancer/leukemia-in-children/about/key-statistics.html. Accessed December 3, 2019.

    4. American Cancer Society. Cancer Facts & Figures 2019. www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2019.html. Accessed December 3, 2019.

    5. Pui C, Evans W. A 50-Year Journey to Cure Childhood Acute Lymphoblastic Leukemia. Seminars in Hematology. 2013;50(3), 185-196.

    6. American Cancer Society. Key Statistics for Acute Lymphocytic Leukemia (ALL). Available at www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html. Accessed December 3, 2019.

    7. Salzer W, Bostrom B, Messinger Y et al. 2018. Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia. Leukemia & Lymphoma. 59:8, 1797-1806, DOI: 10.1080/10428194.2017.1386305.

    8. Hijiya N, van der Sluis IM. Asparaginase-associated toxicity in children with acute lymphoblastic leukemia. Leuk Lymphoma. 2016;57(4):748–757. DOI: 10.3109/10428194.2015.1101098.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-initiation-of-biologics-license-application-submission-for-jzp-458-for-the-treatment-of-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-301196718.html

    SOURCE Jazz Pharmaceuticals plc

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  3. DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that Jennifer Cook and Mark D. Smith, M.D. have been appointed to the Company's Board of Directors, effective December 1, 2020.

    "We are excited to welcome two industry leaders to the Board whose complementary skills and experiences will help us advance our strategy to transform the lives of patients. Jennifer brings over 30 years of biopharmaceutical experience with significant c-suite, product development and commercialization expertise globally, and Mark, a practicing physician, is a nationally-recognized expert in health policy, reimbursement and delivery systems," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Jazz is well-positioned…

    DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that Jennifer Cook and Mark D. Smith, M.D. have been appointed to the Company's Board of Directors, effective December 1, 2020.

    "We are excited to welcome two industry leaders to the Board whose complementary skills and experiences will help us advance our strategy to transform the lives of patients. Jennifer brings over 30 years of biopharmaceutical experience with significant c-suite, product development and commercialization expertise globally, and Mark, a practicing physician, is a nationally-recognized expert in health policy, reimbursement and delivery systems," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "Jazz is well-positioned for transformative growth, with strong commercial franchises, a robust and productive pipeline and a commitment to targeted investments in our global platform. As we seek to leverage our robust R&D assets to develop new treatments and utilize our proven commercialization engine to bring these innovations to market, we will benefit from Jennifer's and Mark's insights and leadership."

    Ms. Cook said, "I am excited to join the Board and look forward to putting my experience to work as the Company brings new and exciting therapies to market. I am impressed by how the team has navigated the current environment, having launched three new products this year alone, and am confident in Jazz's future."

    Dr. Smith added, "This has been a transformative year for Jazz, and I am honored to be joining the Company's Board. Jazz has an important purpose and I am eager to support its mission to deliver life-changing medicines to patients in areas of high unmet need."

    Ms. Cook joins Jazz as a Class II director and will be up for election at the Company's 2022 annual meeting. Dr. Smith joins Jazz as a Class I director and will be up for election at the Company's 2021 annual meeting.

    The Company also announced that after many years of outstanding service and dedication, Elmar Schnee will not seek reelection when his term expires at the Company's 2021 annual meeting of shareholders, and Paul Berns will step down on or before the Company's 2021 annual meeting of shareholders.   

    "I want to express our deepest appreciation for Elmar's and Paul's numerous contributions to Jazz during their many years of service on the Board of Directors," said Mr. Cozadd. "Their industry and product development expertise have been invaluable in positioning Jazz as a leader in sleep medicine with a growing hematology/oncology portfolio. It is an honor to work closely with Elmar and Paul and I look forward to their continued counsel and engagement over the next several months."

    About Jennifer Cook

    Ms. Cook was the Chief Executive Officer at GRAIL, Inc., a privately-held early cancer detection diagnostic company from January 2018 to June 2019. Prior to that, Ms. Cook was at Roche Pharmaceuticals/Genentech for 25 years where she held a number of senior management positions covering the full lifecycle of product development and commercialization. From 2010 to 2013, she oversaw Genentech's U.S. Immunology and Ophthalmology Business Unit, and from 2013 to 2016, she led Roche's European commercial business. She also served as Roche's Global Head of Clinical Operations throughout 2017. In 2016, Ms. Cook was recognized as Woman of the Year by the Healthcare Businesswoman's Association.

    Ms. Cook currently serves as non-executive director on the boards of two publicly-held biotechnology companies, Denali Therapeutics Inc., and BridgeBio Pharma, Inc. She also serves on the board of Ambys Medicines, Inc., a privately-held biotechnology company. Ms. Cook received a B.A. in human biology and a M.S. in biology from Stanford University and an M.B.A. from the Haas School of Business at University of California, Berkeley.

    About Mark Smith, M.D.

    Mark Smith, M.D., is a professor of clinical medicine at the University of California at San Francisco, where he has served since 1994. From 1996 to 2013, Dr. Smith was the founding President and Chief Executive Officer of the California HealthCare Foundation, an independent nonprofit philanthropy organization. Prior to that, from 1991 to 1996, he served as Executive Vice President at the Henry J. Kaiser Family Foundation.

    Dr. Smith currently serves as non-executive director on the boards of two publicly-held healthcare companies, Phreesia Inc. and Teladoc Health, Inc. He also serves on the board of The Commonwealth Fund, a private health policy foundation, and the Institute for Health Care Improvement, an independent nonprofit organization. Dr. Smith holds a B.A. from Harvard College, an M.D. from the University of North Carolina, and an M.B.A. from the Wharton School at the University of Pennsylvania.

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Media Contact:

    Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141         U.S. +1 215 867 4910

    Investor Contact: 

    Kathee Littrell, Vice President, Investor Relations

    Ireland +353 1 634 7887         U.S. +1 650 496 2717

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-appoints-jennifer-cook-and-mark-smith-md-to-its-board-of-directors-301174582.html

    SOURCE Jazz Pharmaceuticals plc

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  4. DUBLIN, Nov. 10, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the following virtual healthcare conference:

    • Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 1:10 p.m. EST / 6:10 p.m. GMT. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.  Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the…

    DUBLIN, Nov. 10, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentation at the following virtual healthcare conference:

    • Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 1:10 p.m. EST / 6:10 p.m. GMT. Daniel Swisher, president and chief operating officer, will provide an overview of the company and a business and financial update.

    A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.  Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

    An archive of the webcast will be available following the presentation for at least one week on the Investors section of the company's website at www.jazzpharmaceuticals.com.

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options.  We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas.  Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies.  Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.  For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Jazz Pharmaceuticals Contacts:





    Investors: 

    Kathee Littrell

    Vice President, Investor Relations

    Ireland +353 1 634 7887

    U.S. +1 650 496 2717

    Media:

    Jacqueline Kirby

    Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141

    U.S. +1 215 867 4910

     

    Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-participation-at-jefferies-virtual-london-healthcare-conference-301170204.html

    SOURCE Jazz Pharmaceuticals plc

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  5. DUBLIN, Nov. 5, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that 11 company-sponsored abstracts, in addition to two abstracts from collaboration trials with The University of Texas MD Anderson Cancer Center (MD Anderson), one abstract from a cooperative group trial and four abstracts from investigator-sponsored trials, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting, which will be held December 5-8, 2020 as a virtual event.

    "This year, we submitted and had more Jazz abstracts accepted for presentation at ASH than ever before, further demonstrating our commitment to research and innovation in hematology and oncology," said Robert Iannone, M.D., M.S.C.E., executive vice president…

    DUBLIN, Nov. 5, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that 11 company-sponsored abstracts, in addition to two abstracts from collaboration trials with The University of Texas MD Anderson Cancer Center (MD Anderson), one abstract from a cooperative group trial and four abstracts from investigator-sponsored trials, will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting, which will be held December 5-8, 2020 as a virtual event.

    "This year, we submitted and had more Jazz abstracts accepted for presentation at ASH than ever before, further demonstrating our commitment to research and innovation in hematology and oncology," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "There continues to be an urgent need for new therapeutics and regimens for people with blood cancers who have limited treatment options or who have a goal to obtain a transplant, and we remain committed to these patients through our ongoing research."

    Oral presentations selected to be presented at ASH include:

    • Long-term outcomes and five-year results from the Phase 3 study of Vyxeos® (daunorubicin and cytarabine), also known as CPX-351, in older adults with newly diagnosed, high-risk/secondary acute myeloid leukemia (AML)
    • Analysis from a multinational, observational registry study evaluating treatment duration, VOD/SOS resolution and survival in patients with veno-occlusive disease/sinusoidal obstruction syndrome treated with Defitelio® (defibrotide sodium) following hematopoietic cell transplantation
    • Results from a Phase 2 study in collaboration with MD Anderson investigating the safety and efficacy of Vyxeos in combination with venetoclax in patients with relapsed or refractory AML

    The ASH abstracts are available online at https://ash.confex.com/ash/2020/webprogram/start.html

    A full list of Jazz-sponsored oral and ePoster presentations follows below:

    Vyxeos Oral and ePoster Presentations

    Presentation Topic

    Author

    Date / Time (PST) /

    Session Title /

    Presentation Number

    Five-Year Final Results of a Phase 3 Study of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed High-Risk/Secondary Acute Myeloid Leukemia (AML): Outcomes by Age Subgroup and Among Responders

    Lancet, et al.

    Oral Presentation:

    Monday, December 7

    12:15 p.m.

    Session Title: 615.

    Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Commercially Available Therapy, Excluding Transplantation II     

    Presentation Number: 635

    CPX-351 Population Pharmacokinetics in Pediatric and Adult Patients with Acute Myeloid Leukemia (AML)

    Wang, et al.

    ePoster Presentation:

    Monday, December 7

    7:00 a.m. – 3:30 p.m.

    Session Title: 615.

    Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster III

    Poster Number: 2848

    Quality-Adjusted Time without Symptoms of Disease and Toxicity (Q-TWiST) Analysis of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed High-Risk/Secondary Acute Myeloid Leukemia (AML)

    Cortes, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 615.

    Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster II

    Poster Number: 1946

    CPX-351 Exposure-Response Analyses for Efficacy and Safety in Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

    Wang, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 615. Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster II

    Poster Number: 1950

    Long-term Outcomes of Allogeneic Hematopoietic Cell Transplantation in Patients Enrolled in CPX-351-301, a Randomized Phase 3 Study of CPX-351 versus 7+3 in Older Adults with Newly Diagnosed, High-Risk and/or Secondary AML

    Uy, et al.

    ePoster Presentation:

    Monday, December 7

    7:00 a.m. – 3:30 p.m.

    Session Title: 732. Clinical Allogeneic Transplantation: Results: Poster III

    Poster Number: 3346

    Analysis of Treatments and Outcomes for Patients with De Novo AML, Therapy-Related AML, and Secondary AML (Prior MDS and CMML) Diagnosed in England between 2011 and 2016 Using Hospital Episode Statistics®

    Legg, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 613.

    Acute Myeloid Leukemia: Clinical Studies: Poster II

    Poster Number: 1929

    Patient Experiences with Liposomal Daunorubicin and Cytarabine (CPX-351) versus Conventional Induction Regimens: An Analysis of Patient-Reported Outcomes Data from a Prospective Trial

    LeBlanc, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 906.

    Outcomes Research –Malignant Conditions (Myeloid Disease): Poster II

    Poster Number: 2572

    V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined with Various Targeted Agents in Patients with Previously Untreated Acute Myeloid Leukemia

    Lin, et al.

    ePoster Presentation:

    Saturday, December 5

    7:00 a.m. – 3:30 p.m.

    Session Title: 615

    Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster I

    Poster Number: 1025

    Exploratory Analysis of the Efficacy and Safety of CPX-351 versus 7+3 by European LeukemiaNet (ELN) 2017 Risk Groups in a Phase 3 Study of Older Adults with High-Risk/Secondary Acute Myeloid Leukemia

    Prebet, et al.

    ePoster Presentation:

    Monday, December 7

    7:00 a.m. – 3:30 p.m.

    Session Title: 615.

    Acute Myeloid Leukemia: Commercially Available Therapy, Excluding Transplantation: Poster III

    Poster Number: 2844

    Post-Marketing Observational Study to Assess the Incidence of Infusion-Related Reactions in Adult Patients with Therapy-Related Acute Myeloid Leukemia (AML) or AML with Myelodysplasia-Related Changes Who Were Treated with CPX-351

    Jacoby, et al.

    Accepted for publication only

    Defitelio Oral and ePoster Presentations

    Presentation Topic

    Author

    Date / Time (PST) /

    Session Title /

    Presentation Number

    Treatment Duration, Symptom Resolution, and Survival in Defibrotide-Treated Patients with Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation: Analysis of a Multinational, Prospective, Observational Registry Study

    Locatelli, et al.

    Oral Presentation:

    Saturday, December 5

    10:15 a.m.

    Session Title: 721.

    Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

    Presentation Number: 138

    Final Primary Results from the DEFIFrance Registry Study: Effectiveness and Safety of

    Defibrotide in the Treatment of Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction

    Syndrome after Hematopoietic Cell Transplantation

    Mohty, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 721.

    Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II

    Poster Number: 2386

    Additionally, data from the following collaboration and investigator-sponsored trials on Vyxeos and Defitelio will be presented:

    Presentation Topic

    Author

    Date / Time (PST) /

    Session Title /

    Presentation Number

    Phase II Study of CPX–351 Plus Venetoclax in Patients with Acute Myeloid Leukemia (AML)

    Kadia, et al.

    Oral Presentation:

    Saturday, December 5

    8:30 a.m.

    Session Title: 616.

    Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Novel Combination Therapies in Treatment of Newly Diagnosed AML

    Presentation Number: 28

    Liposomal Cytarabine and Daunorubicin (CPX–351) in Combination with Gemtuzumab Ozogamicin (GO) in Relapsed Refractory (R/R) Patients with Acute Myeloid Leukemia (AML) and Post–Hypomethylating Agent (Post–HMA) Failure High–Risk Myelodysplastic Syndrome (HR–MDS)

    Perez, et al.

    ePoster Presentation:

    Saturday, December 5

    7:00 a.m. – 3:30 p.m.

    Session Title: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I

    Poster Number: 987

    Initial Results of a Phase 1 Dose Escalation Study of CPX-351 for Patients with Int-2 or High risk IPSS Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) After Failure to Hypomethylating Agents

    Montalban Bravo, et al.

    Accepted for publication only

    Higher Dose of CPX-351 is Associated With Prolonged Hematologic Recovery:

    Results from an Interim Safety Analysis of the Randomized, Phase III AMLSG 30-18 Trial

    Gaidzik, et al.

    ePoster Presentation:

    Saturday, December 5

    7:00 a.m. – 3:30 p.m.

    Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

    Poster Number: 1043

    Outpatient Vyxeos Induction without Planned Admission for Select Patients with

    Secondary Acute Myeloid Leukemia (sAML) Is Safe and Yields Healthcare Resource Savings

    Keiffer, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II

    Poster Number: 1949

    A Phase I/II Trial of CPX-351 + Palbociclib in Patients with Acute Myeloid Leukemia

    Nazha, et al.

    ePoster Presentation:

    Sunday, December 6

    7:00 a.m. – 3:30 p.m.

    Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

    Poster Number: 1962

    A Phase II Study of CPX-351 as a Novel Therapeutic Approach for Patients with Myelodysplastic Syndromes (MDS) after Hypomethylating Agent Failure

    Nazha, et al.

    Accepted for publication only

    Preliminary Results of a Phase II Study to Determine the Safety of Defibrotide in Children

    and Adolescents with Sickle Cell Disease-Associated Acute Chest Syndrome (IND 127812)

    Milner, et al.

    ePoster Presentation:

    Saturday, December 5

    7:00 a.m. – 3:30 p.m.

    Session Title: 114.

    Hemoglobinopathies, Excluding Thalassemia – Clinical: Poster I

    Poster Number: 805

    A Pilot Trial of Pre-Transplant Risk Stratification and Prophylactic Defibrotide to Prevent Serious

    Thrombotic Microangiopathy in High-Risk Pediatric Hematopoietic Stem Cell Transplant Patients

    Higham, et al.

    ePoster Presentation:

    Monday, December 7

    7:00 a.m. – 3:30 p.m.

    Session Title: 721.

    Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster III

    Poster Number: 3307

    Defibrotide for the Treatment of Endotheliitis Complicating Sars-Cov-2 Infection: Rationale and Ongoing Studies as Part of the International Defacovid Study Group

    Moraleda, et al.

    Accepted for publication only

    About Vyxeos® (daunorubicin and cytarabine)

    In the U.S., Vyxeos® (daunorubicin and cytarabine) is a liposomal formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion that represents the first, only and most proven chemotherapy treatment option specifically for two types of high-risk, secondary acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). In Europe, Vyxeos® Liposomal (daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Backed by a robust clinical development program including Phase 3 data, Vyxeos is currently approved in more than 30 countries, and Jazz continues to work with regulatory authorities worldwide to bring this innovative therapy to appropriate patients.

    Important Safety Information for Vyxeos Liposomal

    Vyxeos Liposomal has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos Liposomal for other daunorubicin- and/or cytarabine- containing products.

    Vyxeos Liposomal should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.

    Vyxeos Liposomal can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos Liposomal. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

    Vyxeos Liposomal can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

    • shortness of breath or trouble breathing
    • swelling or fluid retention, especially in the feet, ankles or legs
    • unusual tiredness

    Vyxeos Liposomal may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

    • trouble breathing
    • severe itching
    • skin rash or hives
    • swelling of the face, lips, mouth, or tongue

    Vyxeos Liposomal contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders.

    Vyxeos Liposomal can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

    Vyxeos Liposomal can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos Liposomal. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos Liposomal.

    The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

    Please see full Prescribing Information for Vyxeos Liposomal including BOXED Warning, and visit www.Vyxeos.com for additional information.

    About Defitelio® (defibrotide sodium)

    In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the prevention of VOD.

    Please see full Prescribing Information for Defitelio. 

    In Europe, defibrotide is marketed under the name Defitelio® ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. It is the first and only approved treatment in Europe for severe VOD. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

    ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC. 

    (http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002393/human_med_001646.jsp)

    Defibrotide is currently being investigated in two Phase 2 trials for the prevention of acute Graft-versus-Host-Disease (aGvHD) and the prevention of neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving CAR T-cell therapy. 

    Important Safety Information for Defitelio

    Defitelio should not be given to patients who are:

    • Currently taking anticoagulants or fibrinolytics
    • Allergic to Defitelio or any of its ingredients

    Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision. 

    Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.

    The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

    Please see full Prescribing Information for Defitelio and visit www.Defitelio.com for additional information. 

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

    Media Contact:

    Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations

    Ireland +353 1 697 2141         U.S. +1 215 867 4910

    Investor Contact:

    Kathee Littrell, Vice President, Investor Relations

    Ireland +353 1 634 7887         U.S. +1 650 496 2717

    Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

     

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    SOURCE Jazz Pharmaceuticals plc

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