FDA Grants Approval to Shire for Technology Transfer of CINRYZE® Drug Product Manufacturing Process to Vienna, Austria Manufacturing Site

 FDA Grants Approval to Shire for Technology Transfer of CINRYZE® (C1 esterase inhibitor [human]) Drug Product Manufacturing Process to Vienna, Austria Manufacturing Site


Second production source for Cinryze drug product strengthens Shire's ability
to meet growing patient demand

Dublin, Ireland - January 24, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the U.S. Food and Drug Administration has granted approval for the technology transfer of CINRYZE^® (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site. CINRYZE^® is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE), a rare genetic disease.

"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," said Matt Walker, Head of Technical Operations.

Shire will begin commercial manufacturing of Cinryze drug product in Vienna in the first quarter of 2018. Cinryze will also continue to be produced by a third-party supplier, providing an additional supply source to meet patient demand.

Hereditary angioedema (HAE) is a rare genetic disorder that is thought to affect between 1 in 10,000 and 1 in 50,000 people in the world. HAE can cause attacks of swelling in any part of the body, but the most common locations include the abdomen, face, feet, genitals, hands and throat. HAE attacks affecting the throat are potentially life-threatening, because patients are at risk of suffocation. The swelling in an HAE attack is sometimes painful and can happen without warning or an obvious trigger, lasting for days if untreated.

CINRYZE® (C1 esterase inhibitor [human]) is one of the leading therapies approved for the treatment of HAE in adolescent and adult patients. CINRYZE can help reduce how often attacks occur, how severe they are, and how long they last. Shire's OnePath program offers patients help with their access to the therapy and product support needs. 

  
Indication and Important Safety Information
CINRYZE® (C1 esterase inhibitor [human])

What is CINRYZE?
CINRYZE was the first C1 esterase inhibitor (C1-INH) proven to help prevent swelling attacks in teenagers and adults. CINRYZE can help reduce the frequency, severity and length of attacks.