Approval Makes Xiidra The Apple Of Shire's Eye

Jul. 13, 2016 9:46 AM ETShire PLC (SHPG), SHPGF2 Comments
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The FDA go-ahead for Shire’s (NASDAQ:SHPG) (OTCPK:SHPGF) dry eye drug Xiidra is not only a relief after a checkered path to approval, but should also help the group reduce its reliance on its ADHD franchise. Xiidra is easily the company’s most valuable pipeline asset and is expected to be Shire’s second biggest seller in 2022 behind ADHD drug Vyvanse (see table below).

To get there, Xiidra will need to capture market share from Allergan’s (AGN) Restasis – which might not be too difficult, as Xiidra’s label cites a quicker onset of action and the fact it can treat both the signs and symptoms of dry eye disease. Restasis, meanwhile, is only approved to treat the signs.

Shire has not yet given pricing details but Leerink analysts expect Xiidra to cost about the same as Restasis, at around $300 per prescription, while Evercore ISI’s Umer Raffat believes a premium could be justified.

How well Shire does at luring away Allergan’s customers could depend on its pricing strategy: Xiidra will benefit from a better label, but payers might still prefer Restasis if it is much cheaper.

Shire’s top-five products in 2022

Product

Indication

Status

2022e sales ($m)

Vyvanse

ADHD

Marketed

3,133

Lifitegrast/Xiidra

Dry eye

Approved

1,036

Lanadelumab

Hereditary angioedema

Phase III

809

Cinryze

Hereditary angioedema

Marketed

660

Elaprase

Hunter syndrome

Marketed

621

According to EvaluatePharma consensus

But the drug could also appeal to more patients, with Leerink saying the treatable patient population could number nine million versus the one million currently using Restasis. And the overall market is even bigger: Mr Raffat noted that around 54 million people in the US suffer from dry eye disease, and that around 16 million are seeking treatment.

Dry your eyes mate

The decision is a turnaround for Shire, which

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