Shire Comments On Press Release From NPS Pharma Regarding FDA Approval Of NATPARA® (Parathyroid Hormone)

 

• During animal drug testing, NATPARA caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take NATPARA will have a higher chance of getting osteosarcoma.

• NATPARA is only available through the NATPARA Risk Evaluation and Mitigation Strategy (REMS) Program.  The purpose of the NATPARA REMS program is to inform patients about the potential risk of osteosarcoma associated with the use of NAPTARA.  For more information about this REMS program, call 1-855-628-7272 or go to www.NATPARAREMS.com.

High blood calcium (hypercalcemia)

• NATPARA can cause some people to have a higher blood calcium level than normal.
  • Your doctor should check your blood calcium before you start and during your treatment with NATPARA
  • Tell your doctor if you have nausea, vomiting, constipation, low energy, or muscle weakness.  These may be signs that you have too much calcium in your blood.

Low blood calcium (hypocalcemia)

• People who stop using or miss a dose of NATPARA may have an increased risk of severe low blood calcium levels

• Tell your doctor if you have tingling of your lips, tongue, fingers and feet, twitching of face muscles, cramping of feet and hands, seizures, depression, or have problems thinking or remembering. 

Tell your doctor right away if you have any of these signs and symptoms of high or low blood calcium levels.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of NATPARA?

The most common side effects of NATPARA include

• Tingling, tickling, or a burning feeling of your skin (paresthesia), headache and nausea

These are not all the possible side effects of NATPARA. For more information, ask your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the NPS Adverse Event/Product Complaint Line at 1-855-215-5550 or by calling the Food and Drug Administration (FDA) at 1-800-FDA- 1088 or www.fda.gov/medwatch.

U.S. full prescribing information for Natpara, including boxed warning, is available at http://www.npsp.com/file_depot/0-10000000/0-10000/262/folder/2023/NatparaPI.pdf

For further information please contact:

Investor Relations
Sarah Elton-Farr	[email protected]	+44 1256 894157
Media
Stephanie Fagan	[email protected]	+1 201 572 9581
Jessica Cotrone	[email protected]	+1 781 482 9538

NOTES TO EDITORS

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 we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

www.shire.com

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• a governmental or regulatory approval required for the proposed acquisition of NPS Pharma may not obtained, or may be obtained subject to conditions that are not anticipated, or another condition to the closing of the proposed acquisition may not be satisfied;
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