Jazz recognizes the critical need by patients for Erwinaze and is committed to providing timely, accurate information about Erwinaze supply to the patient and healthcare community.
Both the quality and supply of Erwinaze from Porton Biopharma Limited (PBL), the owner and sole manufacturer of Erwinaze, continue to be of serious concern. These issues have directly resulted in regular global shortages of this life-saving medicine.
Jazz requested 17 batches of Erwinaze for 2020. To date*, PBL has only made 4 batches. Only 1 of those batches (Batch 201) has been deemed suitable for supply to patients to date. Two batches (Batches 200 and 203) are unacceptable for patient use due to insurmountable sterility assurance issues that occurred during PBL’s manufacture of the product. The fourth batch, (Batch 202) remains under investigation at PBL due to foreign matter contamination and has yet to be made available to Jazz.
Because the manufacturing quality of Erwinaze is unreliable, Jazz must take several steps to review manufacturing and quality information provided by PBL. Then, issues identified with the product during this review must be investigated and resolved prior to Jazz picking up product for packaging and labelling. This process can take several months and requires information and assistance from PBL.
Given the life-saving nature of this medicine, Jazz undertakes these additional activities to ensure the product provided to us for collection, which at that time is not suitable for release to patients, can be made suitable for patients. At Jazz, patients are our top priority and we are fully committed to doing what we can to make quality product available to patients.
The types of activities Jazz is required to undertake so we can be confident the product is suitable for patient use, include:
Although every effort is made to expedite this process, these activities require additional time before product is suitable for patient use.
Following these unfortunately necessary activities, if product is confirmed suitable for release to patients, it then undergoes packaging, labelling and distribution (and, in some instances, review by Regulatory Authorities prior to release).
PBL’s manufacturing and quality issues are not new. PBL has been operating under a warning letter from the U.S. Food and Drug Administration (FDA) since January 2017 for repeated contamination of batches of Erwinaze. The warning letter reinforces earlier citations that PBL had not thoroughly investigated why batches of Erwinaze had been contaminated with visible contaminants, including metal, cardboard and some of a proteinaceous nature. The warning letter was the culmination of numerous inspections since 2015, all of which showed serious, new and repeated quality and Good Manufacturing Practice failures by PBL, which PBL repeatedly failed to adequately remediate. This has heighted global scrutiny by other regulators and stakeholders. The letter is available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/porton-biopharma-limited-509689-01172017.
Because PBL owns the product and controls the manufacturing process, we have limited influence over PBL’s practices and are not able to move manufacture from PBL to a different manufacturer.
Jazz has a long-standing commitment to addressing unmet needs for patients with serious health conditions. Jazz recognizes that any supply disruption for Erwinaze can impact patient care, and the company takes this supply disruption very seriously. Jazz has worked extensively with PBL, health authorities, customers and medical institutions to make Erwinaze available, and to educate healthcare providers on any accommodation necessary to address manufacturing deviations to maintain patient care.
Earlier in 2020, PBL announced its decision not to partner with Jazz to commercialize and distribute Erwinaze beginning in 2021. Jazz cannot speculate about what PBL and its new partner’s distribution plans are for Erwinaze following the end of our partnership with PBL. Jazz currently holds the BLA and marketing authorizations for Erwinaz/se in multiple countries and is committed to an orderly transition related to the marketing and distribution of Erwinaze as of 31 December 2020 to ensure continued patient care.
Our goal is and has been to ensure patients with hypersensitivity to E-coli derived asparaginase have access to a safe and effective asparaginase product. Jazz remains committed to the ALL community and if PBL can manufacture and make quality Erwinaze supply available we will continue to distribute Erwinaze as long as it can be deemed suitable for use by patients and we have the distribution rights to do so.
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