Last month, Allergan ($AGN) execs downplayed the threat from Shire's ($SHPG) dry-eye candidate to its own blockbuster Restasis, pointing out that their company had its own new dry-eye product in the works. But now, it's run into a regulatory snag.
The FDA handed the Dublin drugmaker a complete response letter on the multidose, preservative-free formulation of Restasis, it said Thursday. Regulators want to see more information about the drug's bottle--a "first-of-its-kind" container, Allergan says, with a uni-directional valve and air filter technology that the company has patented.
It's a setback for the pharma, which is counting on its new-and-improved version of Restasis to ward off forthcoming competition from Shire prospect lifitegrast. On Q4's conference call, Allergan's president of branded pharma, Bill Meury, told investors the new version would be easier to administer than its predecessor, and users would receive one 60-dose vial instead of 60 single-unit vials.Allergan's Bill Meury
"I think dry eye sufferers are going to love it," Meury said, adding, "I like the overall outlook for the business."
As Allergan said in a statement, though, as long as the agency doesn't follow up with another data request, the company doesn't "anticipate a significant impact" to its timeline for the drug, which it has expected to win approval in the second half of this year.
Shire has already shown lately that a CRL comeback may be possible. Last October, it ran into its own FDA roadblock when it picked up a CRL for lifitegrast. But just over three months later, it was back with a resubmission--including new Phase III data--giving it hope that it may still be able to snag an FDA go-ahead by the end of this year.
- read Allergan's release
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