Shire ($SHPG) has the approval it’s been waiting for--and the label it wanted, too.
Late Monday, the FDA green-lighted dry-eye candidate lifitegrast, to be marketed under the brand name Xiidra. And the go-ahead is for both symptoms and signs of the condition--a label that Evercore ISI analyst Umer Raffat said “reads favorably for lifitegrast’s perception in the marketplace” as it faces down rival Restasis from Allergan ($AGN).
The med has taken longer to get to this point than Shire once hoped. Back in October, U.S. regulators handed down a rejection for the Dublin drugmaker, asking for an additional study and more product quality before they would bestow their favor. Shire was quick to meet their requests, though, rounding up positive data that dropped one week after the setback and turning right around with January resubmission.
Now, it’ll get a shot at a market that Bernstein analyst Ronny Gal expects to grow to close to $2 billion, he wrote in a Tuesday investor note. And it’ll also get a shot at stealing share from Restasis, an Allergan blockbuster he expects to decline from $1.3 billion to $900 million in 2020.
The reason? Restasis lacks Xiidra’s full dry eye label; it’s indicated only for “tear production.” That difference will buoy Xiidra in the marketplace, Raffat wrote in a Monday note to clients, and it could also help Shire make a case for pricing the newcomer at a premium to its nemesis.
But Allergan investors needn’t fret. “The key point regarding the competitive matchup is that it will likely be a stable oligopoly,” Gal wrote, noting that while Shire has the label advantage--plus a shorter onset of action--Allergan “enjoys the power of incumbency,” including contracts, sales and an established patient pool.
And even if Xiidra does grab some Restasis volume--say, 30% over time, Raffat estimates--Allergan may be able to offset about 10% to 15% of the top through a series of price increases, he figures.
- read Shire's release
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