Shire target NPS Pharma wins FDA approval for Natpara

Shire has hailed the regulatory approval of a rare disease drug created by NPS Pharmaceuticals, a firm that the FTSE 100 group is currently in the process of acquiring, and received good news about one of its own drugs.
Natpara, a drug for the rare hormone disorder hypoparathyroidism, has been approved by the US Food and Drug Administration (FDA) as an adjunct to calcium and vitamin D to control hypocalcemia and produce insufficient levels of parathyroid hormone (PTH), which hypoparathyroidism sufferers lack.

NPS, which Shire is set to acquire for $5.2bn, has said Natpara is expected to become available in the second quarter of 2015.

Shire also announced that its investigational drug SHP609, Idursulfase-IT, has received FDA fast-track designation for the treatment of neurocognitive decline associated with Hunter Syndrome

The group’s chief executive officer, Flemming Ornskov, said: “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 US after the expected close of the transaction in Q1 of this year.”

Mike van Dulken, head of research at Accendo Markets, said the NPS news “adds weight” to SHP’s acquisition plans in order to help accelerate growth via an innovative portfolio and market expertise in gastro disorders and rare disease management.

“The brace of positive news is helping the shares above recent highs and near to closing the mid-Oct gap-down from 5,100p when AbbVie pulled out of its planned $54bn acquisition for Shire following a change in US tax inversion rules.”

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