In January, Salisbury, UK-based contract manufacturing organisation (CMO) Porton Biopharma Limited (PBL) received a warning from the US Food and Drug Administration (FDA) citing a number of cGMP deviations relating to the manufacture of Erwinaze (asparaginase Erwinia chrysanthemi) – approved to treat acute lymphoblastic leukemia (ALL) in patients with allergies to E. coli derived chemotherapy drugs.
While the manufacturing and sale of Erwinaze is still permitted, for the biologics license application (BLA) holder Jazz Pharmaceuticals the FDA's warning created “fluctuations in inventory levels and temporary disruptions to the company's ability to supply certain markets, including the US,” the company said in an end-of-year release yesterday.
Expanding capacity initiatives
Erwinaze is exclusively licensed to Jazz by PBL – a company wholly owned by the UK Government – which also serves as the sole supplier.
On a call with stakeholders, Jazz CEO Bruce Cozadd said the manufacturing problems were having “a meaningful impact” on the firm and supply constraints are likely to continue throughout 2017.
“There's both the current demand we can't supply, which is particularly painful to us, but there's also demand beyond that that we're not helping to generate because of supply constraints,” he told stakeholders.
“We and PBL certainly are working on initiatives that will expand effective capacity, ability to produce more products in a calendar year, and simply put, we'll be able to sell what we can supply.”
COO Russell Cox added a number of efforts are already underway including what he described as “24/7 shifts” at the production site to increase capacity by “doing more shifts on a regular basis.”
He added: “We've also brought in an efficiency expert who has analysed every possible way to increase efficiencies within PBL. We're pleased with some of the recommendations that are coming out of there.”
However, he acknowledged these initiatives will take some time to actually generate additional supply.
For the full year 2016, sales of the orphan drug clocked in $105m in sales for Jazz, up 1% year-on-year.