Jazz scales back Erwinaze push due to manufacturing disruptions

To minimize impact on patients, Jazz Pharmaceuticals has reduced promotion of its cancer drug due to continued manufacturing issues at its CMO Porton Biopharma Limited (PBL).

Erwinaze (asparaginase Erwinia chrysanthemi), an asparaginase enzyme derived from the bacteria Erwinia chrysanthemi, is used for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. The product is made for Jazz Pharmaceuticals by Wiltshire, UK-based and UK-government backed biomanufacturer PBL.

However, the US Food and Drug Administration (FDA) sent PBL a warning letter in January 2017 citing deficiencies relating to aseptic operations, failures in investigating particulate matter observed in batches of Erwinaze, and problems with the firm’s management of process changes surrounding the working cell banks. The drug is currently on the FDA shortage list.

Despite this, for the second quarter 2018, Jazz reported a 20% year-on-year increase in sales of Erwinaze, to US$59 million (€52 million), but in a financial call warned that the supply disruptions will continue to occur for the remainder of 2018.

“While we unfortunately continue to have supply challenges, we are actively working with the manufacturer, PBL, to do everything that we can to improve future reliability of supply,” said CEO Bruce Cozadd.

Promotion pull back

“While we have had some supply outages for periods of time, of course at the conclusion of those outages, we’ve generally been able to ship significant product out and try to get it to all patients who need treatment,” he continued.

However, “to minimize impact at the patient level in terms of availability of product” the firm has decided to scale back on its marketing push for the cancer drug.

“Knowing we’ve not had sufficient product supply to meet all demand, we have chosen to reduce our promotional efforts around that,” said Cozadd. “So we don’t want to go out and create demand, particularly in new patient populations that we then can’t satisfy.”

New Erwinaze plant

Though not mentioned in the investor call, shortage may be alleviated through an additional 2,100 m2 facility at PBL, which opened its doors earlier this year. Full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.

“This facility will be the main Erwinaze production facility when on-line and will enable us to increase capacity from our current production facility,” PBL spokesperson Phil Luton told BioProcess Insider in May.

The facility is built around a stainless steel bioreactor, supplied by Pierre Guerin with a working volume of 3,000 L. It is also houses downstream processing rooms for harvesting product.