Jazz Pharmaceuticals says further supply outages for its cancer enzyme Erwinaze are expected amid ongoing manufacturing issues at its sole CMO.
For the third quarter 2018, Jazz Pharmaceuticals reported net sales of its acute lymphoblastic leukemia (ALL) drug Erwinaze (asparaginase Erwinia chrysanthemi) of $41 million (€36 million), down 16% on the same period last year.
“Supply challenges continued to impact product availability in the third quarter,” CEO Bruce Cozadd told stakeholders on a conference call (transcript here). He predicted further supply outages in the fourth quarter and into 2019. “We can’t sell product we don’t have.”
Erwinaze – known as Erwinase outside the US – is licensed from Porton Biopharma Limited (PBL), a UK government owned company that serves as the sole manufacturer of the enzyme. The firm’s facility in Wiltshire, UK was hit by a US Food and Drug Administration (FDA) warning letter in January 2017, which it is yet to have shaken off.
“There hasn’t been yet an inspection that went in and showed that everything had been rectified, although I think progress is being made,” Cozadd said on the call.
The firm has lowered its full year revenue guidance for Erwinaze to a range of $165 million to $175 million from a previous range of $190 million to $220 million.
This is because of a production slow-down due to a combination of ongoing quality issues and the undertaking of a corrective action plan, meaningfewer batches with fewer units per batch are coming out of PBL, Cozzard said.
“For several years we’ve been unhappy about occasional temporary supply outages that have meant there are days or weeks when we couldn’t ship product. But you’ll notice, we really didn’t have to change our guidance intra year. It was a question of timing of shipments. And this time we’re coming along late in the year and making a substantial negative revision to guidance, which indicates that this isn’t just about timing of receipt of product, it is really about how much product we can get. And that’s a worse situation we’ve been in.”
He added efforts are underway to improve the situation, and the firm has previously alluded to reducing Erwinaze marketing to minimize the impact on patients. Furthermore, earlier this year PBL told this publication that a 3,000 L second manufacturing plant at its site could help alleviate the shortage. However, Cozzard warned supply is expected to be restricted for the medium-term.
“Even in a good scenario, we’re still supply constrained and in a bad scenario like the one we’re in now, even our existing revenue level can be at risk,” he said. “Unfortunately right now, we’re living something that while we’ve written about it as a risk factor for several years in terms of the potential for even worse supply situation, we hadn’t seen it until now.”