- Shire plc this week said the Food and Drug Administration had accepted an application requesting the company be allowed to produce Cinryze in-house due to continued issues with the drug's current and only manufacturer.
- The news came as Shire reported a 66% year-over-year decline in sales of the hereditary angioedema (HAE) drug. The company attributed the poor performance to a manufacturing interruption at Sanquin Blood Supply Foundation that caused Cinryze supply shortages starting in August.
- Those production problems have since been resolved, but Shire isn't looking to take any more chances on what have been "historic difficulties" with the contract manufacturing organization. The Irish pharma expects in-house Cinryze manufacturing to begin in early 2018.
Cinryze (C1 esterase inhibitor) has been under Shire's ownership since the company agreed to acquire ViroPharma Inc. back in November 2013 for more than $4 billion. Yet even before that transaction, manufacturing issues have plagued the drug.
A few months before that transaction, Sanquin received a Food and Drug Administration warning letter detailing how its Amsterdam and Brussels facilities were in violation of current good manufacturing practices (cGMP) with regard to process controls and cleaning procedures, among other things.
More manufacturing snafus have sprouted up in the years since. Shire detailed in a first quarter earnings call this spring how Cinryze sported 38% growth as supply troubles from 2016's third quarter had ironed out. It appears more issues have now arisen, however.
"Since the time we acquired the product from ViroPharma in 2014, ensuring a sufficient and reliable supply of Cinryze has been our top priority," Shire CEO Flemming Ornskov said last week during the company's third quarter earnings call. "This has been a challenge at times as demand for Cinryze has periodically exceeded the supply our third-party partner has been able to produce."
Once again, Shire said the proverbial fires at Sanquin's facilities had been put out and that production had resumed. The pharma also benefited from shipping about $100 million worth of Cinryze in October rather than September, giving the drug a strong start in the fourth quarter.
But Shire isn't waiting around for another setback. The company acknowledged earlier this year it planned to make 30% of the Cinryze supply in-house over the long-term — and its announcement last week looks to be another step toward that end.
"In terms of any longer-term implications from this shortage, we believe that we may have lost some HAE patients who have opted for other products," Flemming Ornskov said during the company's most recent earnings call.
"But given that some patients still had Cinryze inventory on hand, given patient loyalty to Shire, and the availability of Shire's Firazyr access program during this time period, we would expect that the majority of existing Cinryze patients will remain on product moving forward as our supply normalizes."