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Shire files for FDA approval of a new plasma manufacturing facility in Covington, Georgia to support growing Immunology franchise

Dublin, Ireland – December 27, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that it has filed its first submission to the United States Food and Drug Administration for the company’s new plasma manufacturing facility in Covington, Georgia. The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.

The first submission is for the transfer of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

“We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our Immunology franchise,” said Matt Walker, Head of Technical Operations for Shire.

Shire has experienced significant growth in Immunology, including a +21% increase in September year-to-date product sales in 2017 (on a pro-forma basis). 

The Covington, Georgia site currently employs approximately 900 full-time colleagues and contract employees. The site plans to ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles. 

Shire also expects to continue expansion of its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington, Georgia facility. 

Indication and Important Safety Information

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution

What is GAMMAGARD LIQUID?

• GAMMAGARD LIQUID is indicated for the treatment of primary humoral immunodeficiency diseases (PI) in patients two years of age and older. GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
• GAMMAGARD LIQUID is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI.
• GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.

Important Safety Information

What is the most important information that I should know about GAMMAGARD LIQUID? 
GAMMAGARD LIQUID can cause the following serious reactions:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use GAMMAGARD LIQUID? 
Do not use GAMMAGARD LIQUID if you:

• Have a known history of a severe allergic reaction to IgG or other blood products.
• Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.

GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
• Fever over 100ºF. This could be a sign of an infection.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID for PI?

• The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions: Mild or moderate pain, swelling, itching, redness, bruising, and warmth.
• During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects: Headache, migraine, fever, fatigue, itching, rash/hives, cough, chest pain/tightness, chills/shaking chills, dizziness, nausea/vomiting, faster heart rate, upper abdominal pain, increased blood pressure, muscle cramps, and sore throat.