Company Announcements

Jazz’s Commitment to ALL Patients: Next Steps in 2021

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Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.1 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.2 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.3 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.4 Hypersensitivity reactions affect up to 30 percent of patients with ALL who are treated with E. coli-derived asparaginase.4

Since 2012, we have been committed to supporting patients with ALL and ongoing research for this patient population. Jazz has been the commercial partner to Porton Biopharma Limited (PBL), the owner and manufacturer of Erwinaze/se, a treatment option for ALL patients with a sensitivity to E. coli-derived asparaginase. Earlier this year, PBL announced its decision to move forward with a new partner, Clinigen, to commercialize and distribute Erwinaze/se in 2021.

Our agreement with PBL ends on December 31, 2020, but Jazz has the right to distribute certain Erwinaze/se inventory in 2021. While the duration of Erwinaze/se supply availability will vary by market, we anticipate being able to distribute Erwinaze/se through Q1 of 2021, subject to quality and regulatory reviews of the product made available to Jazz for distribution.

We understand that PBL is progressing a regulatory and supply strategy independent of Jazz, however Jazz has not been made aware of the details of, and cannot speculate about, PBL and Clinigen’s distribution plans for Erwinaze in 2021.

Jazz remains committed to this patient population and is advancing our own recombinant development programs as quickly as possible. We continue to recognize that any Erwinas/ze supply disruption has the potential to impact patient care. We take any supply disruption very seriously and will continue to take steps to support patient care during the time period that we are responsible for Erwinas/ze distribution.

Erwinaze Important Safety Information

ERWINAZE is part of a chemotherapy program to treat patients who have acute lymphoblastic leukemia (ALL), a type of blood cancer that affects the white blood cells that help fight infection. ERWINAZE is used in patients who have had an allergic reaction to a different type of asparaginase treatment.

ERWINAZE should not be given to people who have had: serious allergic reactions to ERWINAZE (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing – some of which may be life-threatening), or had serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding with past L-asparaginase treatment.

Contact your doctor immediately if you have any of the following serious side effects: allergic reactions, including a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing – some of which may be life-threatening, swelling of the pancreas (stomach pain), too much sugar in your blood (may be thirsty or need to urinate often), or blood clots (may have headache or pain in leg, arm, or chest) or bleeding.

Some of the most common side effects with ERWINAZE include: allergic reactions, too much sugar in your blood, fever, swelling of the pancreas, local reactions (swelling, rash, etc. where the needle entered your skin), vomiting, feeling nauseous, blood clots (may have headache or pain in leg, arm, or chest), liver problems, stomach pain/discomfort, and diarrhea.

ERWINAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving ERWINAZE and for 3 months after the final dose.

These are not all the possible side effects of ERWINAZE. For more information, ask your healthcare provider.

Call your doctor for medical advice about any side effects.

Please see full Prescribing Information and discuss with your doctor.

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.


References
  1. 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 16, 2020.
  2. 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.
  3. 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.
  4. 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.