It's been just over three months since the FDA handed Shire ($SHPG) a rejection for dry eye candidate lifitegrast, giving rival Allergan ($AGN) a boost in the process. But now, the company is back with a resubmission.
In response to regulators' request for an additional study, the Dublin drugmaker's new-and-improved application for the blockbuster hopeful includes positive Phase III data from the OPUS-3 trial that dropped one week after the FDA rejection. With that, the NDA "now includes data from 5 randomized controlled clinical trials, with more than 2,500 patients, making it the largest data set for an investigational stage compound in dry eye disease to date," Shire R&D chief Philip Vickers said in a statement.
Shire hopes that'll be plenty to sway the agency, and the way Bernstein analyst Ronny Gal sees it, it "should be enough for approval," he wrote in a note to clients when the OPUS-3 data hit.
That means rival Allergan--set to join forces with Pfizer ($PFE) this year--had better watch out. Shire's drug takes less time to work than rival Restasis does, and it has posted efficacy in as many or more trial patients, Gal noted, making lifitegrast seem "somewhat superior" to its competitor.Shire CEO Flemming Ornskov
And it may not be too long before the $1.2 billion Allergan product gets its competition. In October, Shire CEO Flemming Ornskov said a first-quarter resubmission could keep lifitegrast "on track" for its planned launch later this year.
Meanwhile, Shire has plenty to keep it busy with a pair of new buys in tow. Earlier this week, it closed a buyout of Dyax, maker of on-market hereditary angioedema med Kalbitor and a candidate for the same disease that could have eventually gone up against its own contender, Cinryze. During this month's J.P. Morgan Healthcare Conference, Shire announced it had inked a pact to buy long-coveted target Baxalta ($BXLT), meaning cost cutting and divestitures could be on the horizon.
- read the release
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