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Agreements

Date: 2015-08-25

Type of information: Production agreement

Compound: Cinryze® (C1 esterase inhibitor )

Company: Shire (UK - USA) Sanquin Blood Supply (The Netherlands)

Therapeutic area: Rare diseases - Genetic diseases

Type agreement:

production

manufacturing

Action mechanism:

enzyme inhibitor/C1 esterase inhibitor. The C1 inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema. Cinryze® is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.

Cinryze® was developed by Viropharma that has been acquired by Shire in 2014.

Disease: hereditary angioedema (HAE)

Details:

* On August 25, 2015, Shire announced it has entered into an agreement with Sanquin Blood Supply, the manufacturer of Cinryze® (C1 esterase inhibitor [human]), providing Shire access to its manufacturing technology and allowing Shire to source additional manufacturers to meet the growing demand for Cinryze®. “We wanted the freedom to operate and expand in a way that makes strategic sense for our business,” said Flemming Ornskov, M.D., CEO, Shire. “When Shire acquired ViroPharma in January 2014, we inherited an arrangement under which Sanquin was the exclusive manufacturer for Cinryze®. We’re pleased that Sanquin was open to expanding our partnership and agreeing to support us as we increase production options for this important therapy.”

The specific terms of the agreement are confidential, but involve payments to Sanquin on achievement of certain milestones, including a successful technical transfer to a second source manufacturer. Sanquin will continue to serve as a key partner with Shire to increase global supply of Cinryze®.

Financial terms:

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Is general: Yes