Shire to Attain Enhanced CINRYZE® Manufacturing Flexibility and Capacity

Shire to Attain Enhanced CINRYZE® Manufacturing Flexibility and Capacity

The company enters into new agreement with Sanquin

Lexington, Mass. – August 25, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today 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.

About CINRYZE

CINRYZE is used for the prophylactic treatment of Hereditary Angioedema (HAE). HAE is a rare genetic disease characterized by recurrent sudden attacks of swelling of the skin or the mucous membranes which can be disfiguring, painful and potentially life-threatening in the case of laryngeal attacks. One of Shire's top selling products, CINRYZE generated $503 million in sales in 2014.

Indication

CINRYZE® (C1 esterase inhibitor [human]) is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE). 

Important Safety Information

You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

Tell your healthcare provider about all of your medical conditions, including if you:

  • have an indwelling catheter/access device in one of your veins.
  • have a history of blood clots, heart disease, or stroke.
  • are taking birth control pills or androgens.
  • are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.

Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

  • wheezing
  • difficulty breathing
  • chest tightness
  • turning blue (look at lips and gums)
  • fast heartbeat
  • swelling of the face
  • faintness
  • rash
  • hives

Serious blood clots may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

  • pain and/or swelling of an arm or leg with warmth over the affected area
  • discoloration of an arm or leg
  • unexplained shortness of breath
  • chest pain or discomfort that worsens on deep breathing
  • unexplained rapid heart rate
  • numbness or weakness on one side of the body

Because CINRYZE is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common side effects seen with CINRYZE were headache, nausea, rash, and vomiting. These are not all the possible side effects of CINRYZE. Tell your healthcare provider about any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report side effects to Shire Medical Information at 1-866-888-0660.

Please see Full Prescribing Information.

About Shire
 

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

www.shire.com

For further information please contact:
 

Investor Relations

Sarah Elton-Farr

[email protected]

+44 1256 894157

Media

Michele Galen

[email protected]

+1 781 482 1867

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