JAZZ Jazz Pharmaceuticals plc

109.75
+0.14  (+0%)
Previous Close 109.61
Open 110.01
52 Week Low 86.88
52 Week High 154.24
Market Cap $6,074,317,995
Shares 55,346,861
Float 52,294,345
Enterprise Value $6,854,805,434
Volume 440,305
Av. Daily Volume 714,726
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Upcoming Catalysts

Drug Stage Catalyst Date
JZP-258
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
PDUFA priority review
PDUFA priority review
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Defibrotide
acute Graft-versus-Host-Disease (aGvHD)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Lurbinectedin
Small cell lung cancer (SCLC)
Approved
Approved
FDA Approval announced June 15, 2020.
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.
JZP-458
Acute lymphoblastic leukemia (ALL)
Phase 2/3
Phase 2/3
Phase 2/3 enrolment to be completed 4Q 2020.
Solriamfetol (JZP-110)
Excessive daytime sleepiness (EDS) in major depressive disorder
Phase 3
Phase 3
Phase 3 trial to commence mid-2020.
Solriamfetol (JZP-110)
Excessive sleepiness associated with narcolepsy
Approved
Approved
FDA Approval announced March 20, 2019.
JZP-258
Idiopathic Hypersomnia
Phase 3
Phase 3
Phase 3 enrolment to be completed 2H 2020.
JZP-385
Essential Tremor
Phase 2
Phase 2
Phase 2b trial to be initiated 4Q 2020.
Vyxeos in combination with venetoclax
First-line unfit Acute myeloid leukemia
Phase 1b
Phase 1b
Phase 1b ongoing.
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, June 15, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced along with its partner PharmaMar (MSE: PHM) that the U.S. Food and Drug Administration (FDA) approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

    The FDA approval of Zepzelca is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive…

    DUBLIN, June 15, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced along with its partner PharmaMar (MSE: PHM) that the U.S. Food and Drug Administration (FDA) approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1 Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

    The FDA approval of Zepzelca is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.2 The data, which appeared in The Lancet Oncology May 2020 issue, showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35 percent and a median duration of response of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC)).1  

    "Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of Zepzelca and we are proud to partner with them to bring this new therapy to the U.S. market, expanding our presence in oncology."

    Zepzelca will be commercially available in the U.S. in early July. As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.

    "Seeing first-hand the aggressive nature of SCLC and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses," said Dr. Jeff Petty, oncology specialist, Wake Forest Baptist Health. "For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC."

    "We are pleased to bring a new treatment choice to relapsed SCLC patients," said José María Fernández Sousa-Faro, PhD, president of PharmaMar. "The U.S. FDA accelerated approval of Zepzelca underscores its potential to fill an unmet need in this often-overlooked SCLC community."

    Zepzelca is administered by an intravenous (IV) infusion delivering a 3.2 mg/m2 dose over the course of one hour, repeated every 21 days until disease progression or unacceptable toxicity.1 Zepzelca can be administered in an outpatient clinic and its dosing schedule of a single infusion every 21 days may result in less time a patient receives treatment in the clinic or hospital compared to other options.

    The most common adverse reactions (≥20%), including laboratory abnormalities, are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.1  

    "In addition to the physical toll it takes on patients, a relapse of SCLC also takes a mental and emotional toll on the entire family," said Andrea Stern Ferris, president and CEO, LUNGevity. "The availability of Zepzelca presents new hope for patients and their loved ones, and we're eager to see its impact on the SCLC community."

    About the Phase 2 Monotherapy Trial

    The Phase 2 trial of Zepzelca was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the U.S.2 In the trial, platinum-sensitive and platinum-resistant patients were treated with Zepzelca 3.2 mg/m2, administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoint, ORR, was 35 percent and the median duration of response was 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an IRC).1 Zepzelca was discontinued in 1.9 percent of patients and was delayed in 30.5 percent of patients due to an adverse reaction. Dose reductions for an adverse reaction occurred in 25 percent of patients.1

    Investor Webcast on Wednesday, June 17, 2020 at 6:15 p.m. EDT

    The company will host a webcast on Wednesday, June 17, 2020 at 6:15 p.m. EDT/11:15 p.m. IST to provide investors with an update on Zepzelca. The investor webcast will include an overview of SCLC, Zepzelca and launch plans from the company's senior management.  

    A live 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 for at least one week following the presentation on the Investors section of the company's website at www.jazzpharmaceuticals.com.

    More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here. < http://pp.jazzpharma.com/pi/zepzelca.en.USPI.pdf >

    About Zepzelca (lurbinectedin)

    Zepzelca, also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.1

    Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

    Important Safety Information

    Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

    • have liver or kidney problems.
    • are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.

      Females who are able to become pregnant:
      • Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
      • You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
      • Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.

    Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.

      • are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

    What should I avoid while using ZEPZELCA?

    Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

    ZEPZELCA can cause serious side effects, including:

    • Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.

      Tell your healthcare provider right away if you develop:
      • fever or any other signs of infection
      • unusual bruising or bleeding
      • tiredness
      • pale colored skin
    • Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.

       

      Tell your healthcare provider right away if you develop symptoms of liver problems including:
      • loss of appetite     
      • nausea or vomiting          
      • pain on the right side of your stomach area (abdomen)

    Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.

    The most common side effects of ZEPZELCA include:

    • tiredness
    • low white and red blood cell counts
    • increased kidney function blood test (creatinine)
    • increased liver function blood tests
    • increased blood sugar (glucose)
    • nausea
    • decreased appetite
    • muscle and joint (musculoskeletal) pain
    • low level of albumin in the blood
    • constipation
    • trouble breathing
    • low levels of sodium and magnesium in the blood
    • vomiting
    • cough
    • diarrhea

    These are not all of the possible side effects of ZEPZELCA.

    Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

    About PharmaMar

    Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

    PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

    About Jazz Pharmaceuticals plc

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people 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 medicine and movement disorders, and in oncology, including hematologic 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 "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 Jazz Pharmaceuticals' expectations regarding the timing of commercial availability of Zepzelca in the U.S., its potential to fill an unmet need and have an impact on the SCLC community; 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: effectively commercializing Zepzelca, including risks related to the impact of COVID-19 pandemic on the successful launch of Zepzelca; and other risks and uncertainties affecting Jazz Pharmaceuticals, 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 the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and future filings and reports by the company. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect the company's 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.

    References:

    1. ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
    2. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645–654.

    Jazz Pharmaceuticals Media and Investor Relations Contact

    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)

     

    PharmaMar Logo (PRNewsfoto/Jazz Pharmaceuticals plc)

     

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    SOURCE Jazz Pharmaceuticals plc

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  2. DUBLIN, June 9, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ("Jazz Pharmaceuticals") today announced the pricing of $850 million aggregate principal amount of 2.000% exchangeable senior notes due 2026 in a private offering (the "offering") by Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").  The Issuer also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes.  The sale of the notes is expected to close on June 11, 2020, subject to customary closing conditions.

    The notes will be general unsecured…

    DUBLIN, June 9, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) ("Jazz Pharmaceuticals") today announced the pricing of $850 million aggregate principal amount of 2.000% exchangeable senior notes due 2026 in a private offering (the "offering") by Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").  The Issuer also granted the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes.  The sale of the notes is expected to close on June 11, 2020, subject to customary closing conditions.

    The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2020, at a rate of 2.000% per year.  The notes will mature on June 15, 2026, unless earlier exchanged, repurchased or redeemed.  Prior to March 15, 2026, the notes will be exchangeable only upon satisfaction of certain conditions and during certain periods, and thereafter, at any time until the close of business on the second scheduled trading day immediately preceding the maturity date.  The notes will be exchangeable for cash, ordinary shares ("ordinary shares") of Jazz Pharmaceuticals or a combination thereof, at the Issuer's election.  The initial exchange rate will be 6.4182 ordinary shares per $1,000 principal amount of notes (equivalent to an initial exchange price of approximately $155.81 per ordinary share, which represents approximately a 40.0% premium over the closing price per ordinary share on the Nasdaq Global Select Market on June 8, 2020), subject to adjustment in some events but not for any accrued and unpaid interest.  The Issuer's obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals and will rank pari passu in right of payment with the Issuer's existing 1.875% exchangeable senior notes due 2021 (the "2021 notes") and 1.500% exchangeable senior notes due 2024.

    The Issuer may redeem the notes at its option, prior to June 15, 2026, in whole but not in part, in connection with certain tax-related events.  The Issuer also may redeem the notes at its option on or after June 20, 2023 and prior to March 15, 2026, in whole or in part, if the last reported sale price of ordinary shares has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending within the three trading days immediately preceding the date on which the Issuer provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

    If Jazz Pharmaceuticals undergoes a "fundamental change," subject to certain conditions and limited exceptions, holders of the notes may require the Issuer to repurchase for cash all or part of their notes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.  In addition, following certain corporate events that occur prior to the maturity date of the notes or upon the Issuer's issuance of a notice of redemption, the Issuer will, in certain circumstances, increase the exchange rate for holders of the notes who elect to exchange their notes in connection with such a corporate event or exchange their notes called for redemption during the related redemption period, as the case may be. Jazz Pharmaceuticals estimates that the net proceeds from the offering will be approximately $833.6 million (or approximately $981.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers' discount and commissions and estimated offering expenses payable by the Issuer.  The Issuer intends to use approximately $332.9 million of the net proceeds from the offering to repurchase for cash up to approximately $332.9 million aggregate principal amount of the 2021 notes through individual privately negotiated transactions concurrently with the offering of notes.  The remaining net proceeds will be used for general corporate purposes, which may include additional repurchases of 2021 notes from time to time following the offering.  Note repurchases occurring concurrently with the offering of the notes, and the potential related market activities by selling holders of the 2021 notes, could increase (or reduce the size of any decrease in) the market price of the ordinary shares concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes.  Note repurchases that may occur from time to time following the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares or the trading price of the notes.

    None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. 

    This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. 

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options. Jazz Pharmaceuticals has a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas, with a focus in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. Jazz Pharmaceuticals is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. 

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

    This press release contains forward-looking statements, including, but not limited to, all statements related to the closing of the offering, the timing and amount of any repurchases of the 2021 notes, potential effects of the repurchases of the 2021 notes and the expected use of net proceeds from the offering.  These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  Do not place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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 the satisfaction of closing conditions related to the offering and market risks, trends and conditions.  These and other risks and uncertainties relating to Jazz Pharmaceuticals and its business can be found under the caption "Risk Factors" and elsewhere in its Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including its recently filed Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as future filings and reports by Jazz Pharmaceuticals.  Except as required by law, Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations. 

     

    Jazz Pharmaceuticals Contacts:







    Investors:



    Media:

    Kathee Littrell



    Jacqueline Kirby

    Vice President, Investor Relations



    Vice President, Corporate Affairs & Government Relations

    Ireland, +353 1 634 7887



    Ireland, +353 1 697 2141

    U.S., +1 650 496 2717



    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-pricing-of-private-offering-of-850-million-of-2-000-exchangeable-senior-notes-due-2026--301072646.html

    SOURCE Jazz Pharmaceuticals plc

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  3. DUBLIN, June 8, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), intends to offer, subject to market conditions and other factors, $850 million aggregate principal amount of exchangeable senior notes due 2026 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").  The Issuer also expects to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes.

    The notes will be exchangeable under certain circumstances for cash, ordinary shares ("ordinary…

    DUBLIN, June 8, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), intends to offer, subject to market conditions and other factors, $850 million aggregate principal amount of exchangeable senior notes due 2026 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").  The Issuer also expects to grant the initial purchasers of the notes a 13-day option to purchase up to an additional $150 million aggregate principal amount of notes.

    The notes will be exchangeable under certain circumstances for cash, ordinary shares ("ordinary shares") of Jazz Pharmaceuticals plc ("Jazz Pharmaceuticals"), or a combination thereof.  The interest rate, initial exchange rate and other terms of the notes will be determined at the time of pricing of the offering. The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears.  The Issuer's obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals and will rank pari passu in right of payment with the Issuer's existing 1.875% exchangeable senior notes due 2021 (the "2021 notes") and 1.500% exchangeable senior notes due 2024.  

    The Issuer intends to use a portion of the net proceeds from the offering to repurchase for cash up to approximately $400 million aggregate principal amount of the 2021 notes through individual privately negotiated transactions concurrently with the offering of the notes. The remaining net proceeds will be used for general corporate purposes, which may include additional repurchases of 2021 notes from time to time following the offering.  Note repurchases occurring concurrently with the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. Note repurchases that may occur from time to time following the offering of the notes could increase (or reduce the size of any decrease in) the market price of the ordinary shares or the trading price of the notes.

    None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. 

    This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.  

    About Jazz Pharmaceuticals

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options.  Jazz Pharmaceuticals has a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas, with a focus in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. Jazz Pharmaceuticals is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries. 

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

    This press release contains forward-looking statements, including, but not limited to, all statements related to the offering and proposed terms of the notes and the expected use of the net proceeds from the offering, including the timing and amount of any repurchases of the 2021 notes and the potential effects of the repurchases of the 2021 notes.  These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties.  Do not place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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 market risks, trends and conditions. These and other risks and uncertainties relating to Jazz Pharmaceuticals and its business can be found under the caption "Risk Factors" and elsewhere in its Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including its recently filed Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as future filings and reports by Jazz Pharmaceuticals.   Except as required by law, Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations. 

    Jazz Pharmaceuticals Contacts:













    Investors:



    Media:

    Kathee Littrell



    Jacqueline Kirby

    Vice President, Investor Relations



    Vice President, Corporate Affairs & Government Relations

    Ireland, +353 1 634 7887



    Ireland, +353 1 697 2141

    U.S., +1 650 496 2717



    U.S., +1 215 867 4910

     

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  4. DUBLIN, May 27, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentations at the following virtual investor conferences:

    • Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 4:30 p.m. EDT / 9:30 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
    • Goldman Sachs Virtual Healthcare Conference on Wednesday, June 10, 2020 at 11:20 a.m. EDT / 4:20 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.

    A live audio webcast of each presentation may be accessed from the Investors section of…

    DUBLIN, May 27, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the company will webcast its corporate presentations at the following virtual investor conferences:

    • Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020 at 4:30 p.m. EDT / 9:30 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.
    • Goldman Sachs Virtual Healthcare Conference on Wednesday, June 10, 2020 at 11:20 a.m. EDT / 4:20 p.m. IST. Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update.

    A live audio webcast of each 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 each presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

    An archive of each webcast will be available for at least one week following each presentation 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 life-changing medicines for people 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 medicine and movement disorders, and in oncology, including hematologic 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

     

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  5. DUBLIN, May 14, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that it and its partners will present seven new abstracts at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting from May 29-June 2, 2020 and six abstracts at the virtual 25th Annual Congress of the European Hematology Association (EHA) from June 11-14, 2020. These new data from Jazz's expanding hematology and oncology portfolio and pipeline are focused on difficult-to-treat cancers, or related disorders, which have few, if any, treatment options.  

    "Jazz is committed to oncology, including developing meaningful hematologic and solid tumor therapies that address unmet needs of patients facing unique challenges and difficult odds…

    DUBLIN, May 14, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that it and its partners will present seven new abstracts at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting from May 29-June 2, 2020 and six abstracts at the virtual 25th Annual Congress of the European Hematology Association (EHA) from June 11-14, 2020. These new data from Jazz's expanding hematology and oncology portfolio and pipeline are focused on difficult-to-treat cancers, or related disorders, which have few, if any, treatment options.  

    "Jazz is committed to oncology, including developing meaningful hematologic and solid tumor therapies that address unmet needs of patients facing unique challenges and difficult odds," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "Our dedication to patient-centered research, through internal R&D capabilities and strategic external partnerships, will help ensure a greater number of people benefit from the development of new treatment options, as well as expand our presence in oncology."

    Research findings to be presented include new data from Jazz's marketed products, Vyxeos®/Vyxeos® Liposomal (daunorubicin and cytarabine), also known as CPX-351, and Defitelio® (defibrotide sodium), as well as late-stage investigational drug candidates, JZP-458 and lurbinectedin.

    Highlights from Jazz and its partners at ASCO will include:

    • A poster discussion presentation featuring final results from a five-year analysis of a pivotal Phase 3 study comparing outcomes for Vyxeos (CPX-351) versus 7+3 in older adults with newly diagnosed high-risk/secondary acute myeloid leukemia (sAML)
    • A poster presentation from Jazz's partner, PharmaMar, featuring a pooled safety analysis of lurbinectedin from the Phase 2 basket study

    Highlights from Jazz at EHA will include:

    • A poster presentation featuring final results from a five-year analysis of a pivotal Phase 3 study comparing outcomes for CPX-351 versus 7+3 in older adults with newly diagnosed high-risk/sAML
    • A poster presentation of outcomes in adult and pediatric patients from an observational registry study of defibrotide treatment for veno-occlusive disease/sinusoidal obstruction syndrome after hematopoietic cell transplantation

    All ASCO virtual poster presentations and poster discussion presentations will be available on-demand to registered participants for 180 days beginning May 29, 2020. The Jazz-supported and partner poster and poster discussion presentations covering CPX-351, JZP-458 and lurbinectedin at the ASCO Annual Meeting are:

    Vyxeos Poster and Poster Discussion Presentations

    Presentation Title

    Author

    Poster Number / Abstract Link

    Phase 1B Study of CPX-351 Lower-Intensity Therapy Plus Venetoclax as First-Line Treatment for Patients with Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy (trial in progress)

    Lin et al.

    Poster Number: 340

    Abstract Link

    Outcomes in Older Patients with High-Risk/Secondary Acute Myeloid Leukemia Who Achieved Remission with CPX-351 Versus 7+3 But Did Not Undergo Transplant: Phase 3 Exploratory Analysis

    Lin et al.

    Poster Number: 310

    Abstract Link

    Five-Year Final Results of a Phase III Study of CPX-351 Versus 7+3 in Older Adults with Newly Diagnosed High-Risk/Secondary Acute Myeloid Leukemia (Poster discussion)

    Lancet et al.

    Poster Number: 283

    Abstract Link

    Children's Oncology Group Poster Presentation

    Presentation Title

    Author

    Poster Number / Abstract Link

    Change in Cardiac Function with CPX-351 in Relapsed Pediatric Acute Myeloid Leukemia Patients: A Children's Oncology Group (COG) Report from AAML 1421

    Leger et al.

    Poster Number: 419

    Abstract Link

    JZP-458 Poster Presentation

    Presentation Title

    Author

    Poster Number / Abstract Link

    Phase II/III Study of JZP-458 in Patients with Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma Who Are Hypersensitive to E. coli-Derived Asparaginases (trial in progress)

    Maese L, et al.

    Poster Number: 341

    Abstract Link

    Lurbinectedin Poster and Poster Discussion Presentations

    Presentation Title

    Author

    Poster Number / Abstract Link

    Pooled Safety Analysis of Single-Agent Lurbinectedin Versus Topotecan

    Leary et al.

    Poster Number: 365

    Abstract Link

    Lurbinectedin in Combination with Irinotecan in Patients with Advanced Solid Tumors (Poster discussion)

    Ponce et al.

    Poster Number: 244

    Abstract Link

    The Jazz-supported poster presentations and publications covering CPX-351 and defibrotide at the 25th Annual Congress of the EHA are:

    Vyxeos Liposomal Poster Presentations

    Presentation Title

    Author

    Abstract Code / Abstract Link / Session Title

    Outcomes in Older Patients with High-Risk/Secondary Acute Myeloid Leukemia Who Achieved Remission with CPX-351 Versus 7+3 But Did Not Undergo Transplant: Phase 3 Exploratory Analysis

    Lin et al.

    Abstract Code: EP562

    Abstract Link

    Session Title: Acute myeloid leukemia – clinical

    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

    Lancet J, et al.

    Abstract Code: EP556

    Abstract Link

    Session Title: Acute myeloid leukemia – clinical

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

    Prebet et al.

    Abstract Code: EP571

    Abstract Link

    Session Title: Acute myeloid leukemia – clinical

    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 2011-2016 Using Hospital Episode Statistics

    Legg et al.

    Abstract Code: EP605

    Abstract Link

    Session Title: Acute myeloid leukemia – clinical

    Patient Experiences with CPX-351 Versus Conventional Induction Regimens: An Analysis of Patient-Reported Outcomes Data from a Prospective Trial

    LeBlanc et al.

    Abstract Code: PB1832

    Abstract Link

    Publication only

    Therapeutic Targeting of DNA-Dependent Protein Kinase Catalytic Subunit (DNA-PKcs) with M3814 in Combination with CPX-351 In TP53wt and TP53mut AML

    Nishida et al.

    Abstract Code: EP473

    Abstract Link

    Session Title: Acute myeloid leukemia - Biology & Translational Research

    Defibrotide Poster Presentation

    Presentation Title

    Author

    Abstract Code / Abstract Link / Session Title

    Defibrotide Treatment for Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation: Outcomes in Adult and Pediatric Patients from an Observational Registry Study

    Mohty et al.

    Abstract Code: EP1377

    Abstract Link

    Session Title: Stem cell transplantation – clinical

    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 JZP-458
    Investigational drug, JZP-458 is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. It is being investigated 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. The FDA has yet to review JZP-458, and its safety and effectiveness have not yet been established. JZP-458 was granted Fast Track designation by the FDA in October 2019.

    About Lurbinectedin (PM1183)
    Lurbinectedin (PM1183) is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. Lurbinectedin was discovered and is owned by Pharma Mar, S.A. (PharmaMar). As previously announced in December 2019, PharmaMar and Jazz Pharmaceuticals have entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to lurbinectedin.  Lurbinectedin is an investigational drug under review by the FDA, and its safety and effectiveness have not yet been established.

    About Jazz Pharmaceuticals plc
    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people 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 medicine and movement disorders, and in oncology, including hematologic 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

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