Shire forms ophthalmic unit, to submit lifitegrast NDA

Shire plc (LSE:SHP; NASDAQ:SHPG) formed a business unit to commercialize its ophthalmic products and said it plans to submit an NDA to FDA for lifitegrast to treat dry eye disease in 1Q15. The submission timeline update came after the company met with FDA to discuss the lifitegrast program, including data from two Phase III trials. In one trial, lifitegrast met the co-primary endpoint of improving patient-reported eye dryness scores but missed the co-primary endpoint of improving inferior corneal staining scores. In a second trial, it met the co-primary endpoint of improving inferior corneal staining scores but missed the co-primary endpoint of improving visual-related function scores. Shire gained lifitegrast -- an eye drop formulation of a small molecule integrin beta(2) (LFA-1; MAC-1; CD18) antagonist -- through its 2013 acquisition of SARcode Bioscience Inc. (see BioCentury, April 1, 2013).

Robert Dempsey will lead Shire's new ophthalmics business unit as VP of eye care. He was executive director of pharmaceutical medical science-North America at Bausch + Lomb Inc. Shire also hired Reza Haque as VP and therapeutic area head for ophthalmology. Haque was global program head at Bausch + Lomb, which Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) acquired last year. ...