Shire Comments on Press Release from NPS Pharma Regarding FDA Approval of NATPARA® (parathyroid hormone)

Shire Comments on Press Release from NPS Pharma Regarding FDA Approval of NATPARA® (parathyroid hormone)

Dublin, Ireland – January 23, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) notes the announcement today by NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) that the U.S. Food and Drug Administration (FDA) has approved NATPARA® (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH. NATPARA is a bioengineered replica of human PTH. NPS has previously indicated that this product is expected to be available in the second quarter of 2015. The full text of the NPS Pharma announcement was posted today on the company's website.

Shire's Chief Executive Officer, Flemming Ornskov, MD, MPH, commented:

"The FDA's approval of NATPARA provides a new treatment option for patients with hypoparathyroidism – a devastating rare disease with significant unmet need. The NATPARA label is in line with our expectations, and we believe this approval further validates Shire's decision to acquire NPS Pharma, which is an excellent strategic fit allowing us to leverage our  market expertise, core capabilities in rare disease patient management, and global footprint. We look forward to combining our strengths with NPS Pharma to launch NATPARA in the U.S. after the expected close of the transaction in Q1 of this year."

Pending satisfaction of customary closing conditions, it is anticipated that the transaction will close during the first quarter of 2015.

About Natpara® (parathyroid hormone) for Injection

Natpara® (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara is a bioengineered replica of human parathyroid hormone.

Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.

In clinical studies, Natpara has been shown to increase serum calcium levels while reducing the need for oral calcium and active vitamin D and, in some cases, eliminate the need for active vitamin D altogether. The most common adverse reactions associated with Natpara and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, and hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity.

Natpara is self-administered once daily by subcutaneous injection. The starting dose of Natpara is 50 mcg once daily.

Natpara received orphan drug status for the treatment of hypoparathyroidism from the FDA in 2007 and the EMA in 2013.

Important Safety Information

What is NATPARA?

·   NATPARA is a prescription parathyroid hormone (PTH) used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low PTH blood levels (hypoparathyroidism).

·   NATPARA is only for people who do not respond well to treatment with calcium and active forms of vitamin D alone, because it may increase the possible risk of bone cancer (osteosarcoma).

·   NATPARA was not studied in people with hypoparathyroidism caused by calcium sensing receptor mutations.

·   NATPARA was not studied in people who get sudden hypoparathyroidism after surgery.

·   It is not known if NATPARA is safe and effective for children 18 years of age and younger. NATPARA should not be used in children and young adults whose bones are still growing.

What is the most important information I should know about NATPARA?

NATPARA may cause serious side effects, including:

Possible bone cancer (osteosarcoma).

·         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

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