The US drug firm provided the update last week, telling investors on its Q3 call it will start making some batches of the enzyme-based hereditary angioedema treatment itself to “enhance reliability of supply” early in 2018.
A spokeswoman confirmed the plan, telling us "Shire is preparing to develop in-house Cinryze manufacturing capabilities to increase volume and reduce the risk of supply constraints in the future.
She declined to say at which facility the drug will be made, telling us "Shire does not share details on where our products are produced."
Shire has sold Cinryze since 2014 when it acquired developer Viropharma.
Netherlands-based contract manufacturing organisation (CMO) Sanquin is the sole supplier of Cinryze at present under a contract established in 2012.
Demand for the drug has “periodically” exceeded supply according CEO Flemming Ornskov, who told investors the most recent shortage occurred this summer.
“Unfortunately, in the third quarter, we experienced a manufacturing interruption resulting in a subsequent product shortage that began in August. We tackled this immediately, and the good news is that the manufacturer [Sanquin] has addressed the issue and resumed production.”
To address the interruption, Shire secured US Food and Drug Administration for permission to release previously made Cinryze. According to Ornskov part of the stockpile - worth $100m - was shipped to the US in October.
In May, Ornskov said the firm would start manufacturing 30% of the global supply.
Plant sale
In other news, the Shire spokeswoman confirmed the firm plans to divest its facility in Milford, Massachusetts
Shire acquired the site when it bought Baxalta. At present 100 people are employed at the facility.