Shire decided to take some production of Cinryze in-house after problems at a contractor last year led to a shortage. The drugmaker said today that with an FDA approval, it will soon start manufacturing the rare disease drug at a site in Europe.
The company said the FDA has signed off on a technology transfer to a Shire manufacturing site in Vienna, Austria, that it got in its $32 billion buyout of Baxalta in 2016. The company said it expects to begin production of Cinryze at the site this quarter. A spokesperson said in an email that Shire was able to add production of the drug to existing lines at the Vienna plant without adding workers.
“With the FDA’s approval of the tech transfer, we are pleased to strengthen our supply reliability for adult and adolescent HAE patients who count on Cinryze to help prevent attacks,” Matt Walker, head of technical operations, said in a statement.
Problems at Dutch contractor Sanquin led to a shortage of the drug in August. While the company scrambled to keep supplies flowing, Shire acknowledged in the third quarter that it lost some patients to competing drugs in the process.
The company, which at one point said it expected to produce about 30% of Cinryze in-house, says it will continue to lean on its third-party supplier as an “additional supply source to meet patient demand.”
The tech transfer comes even as Shire is in the midst of paring back some the 17-plant manufacturing network it was left with after the Baxalta merger. It has said it needs about 12 production facilities and has already begun shedding the extra five. It has deals to sell a vaccine plant in Europe to Merck & Co. and a mammalian manufacturing facility in Hayward, California, to Lonza.