 |
| Shire CEO Flemming Ornskov |
Shire ($SHPG) is gearing up to file an FDA application for lifitegrast, a dry eye treatment it picked up for $160 million, despite some mixed results in a late-stage trial.
The company plans to hand in its NDA in the first quarter of 2015, wrapping up chemistry and manufacturing work in the meantime. The treatment, which starred in Shire's buyout of SARcode Bioscience last year, is a keystone in the drugmaker's quest to build an ophthalmology franchise, but, thanks to a disappointing Phase III trial, those plans might be put on hold.
In a 718-patient study, lifitegrast met the coprimary endpoint of relieving dry eye symptoms compared to placebo but missed the mark on signs of corneal staining, a biomarker for the disease. That 50-50 split led some analysts to question the drug's approvability, figuring the FDA would require a second efficacy trial before green-lighting lifitegrast.
Now Shire is taking a cautious step forward, figuring its combined results on more than 1,800 patients adequately demonstrate lifitegrast's safety and efficacy. In parallel with its NDA preparation, though, Shire said it "will be assessing the need for gathering additional clinical data" on the drug, an acknowledgement that the missed endpoint may pose a threat to the treatment's regulatory future.
Shire is counting on lifitegrast to spell its entry point into the world of ophthalmology, and the company has recruited Bausch + Lomb veteran Robert Dempsey to head up a new business unit dedicated to the field. Behind the dry eye drug, Shire is in the midst of Phase II study with SHP607, designed to prevent a retinal ailment that afflicts premature infants, and the company has "every intention of complementing these compounds with additional pipeline products to address significant unmet patient need in ophthalmics," CEO Flemming Ornskov said in a statement.
The turn toward eye drugs is part of Ornskov's move to institute sweeping R&D reforms since taking the reins last year. The move is both an acknowledgement of the ophthalmology space's growth over the past few years and a return to form for the CEO, who ran Novartis' ($NVS) eye drug business before moving over to Bausch + Lomb.
Lifitegrast is a topical therapy that works by blocking the protein integrin, thereby reducing inflammation and relieving symptoms of dry eye disease, according to Shire.
- read the announcement