shire plc (SHPGF) Key Developments
Shire plc Reports Top-Line Results on OPUS-2, Phase 3 Study Investigating the Use of Lifitegrast (5.0% Ophthalmic Solution) in Adults with Dry Eye Disease
Dec 5 13
Shire plc announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution. OPUS-2 compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in dry eye patients with history of active artificial tear use within 30 days prior to screening. Lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12) (p-value<0.0001). Lifitegrast did not meet the prespecified co-primary endpoint for the sign of inferior corneal staining score (change from baseline to Week 12) using fluorescein staining compared with placebo (p-value=0.6186). The study also evaluated the safety and tolerability of lifitegrast based on occurrence of treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2% vs 0.3% for placebo), instillation site irritation (7.8% vs 1.4% for placebo), instillation site reaction (7.0% vs 1.1% for placebo) and visual acuity reduced (5.0% vs 6.4% for placebo). There were no ocular serious TEAEs or drug-related serious TEAEs. 93.2% of patients enrolled in the study remained for the entire duration of the 12-week clinical trial.
Shire plc Presents at 2013 Therapeutic Area Partnerships Conference, Nov-19-2013 03:10 PM
Nov 15 13
Shire plc Presents at 2013 Therapeutic Area Partnerships Conference, Nov-19-2013 03:10 PM. Venue: One Avenue De Lafayette, Boston, MA 02111, United States. Speakers: Sam Rasty, PhD, Vice President, New Products Rare Disease Business Unit.
Shire plc, ViroPharma Inc. - M&A Call
Nov 11 13
To discuss the merger agreement between Shire and ViroPharma
Shire Pharmaceuticals Presents at UBS European Conference, Nov-12-2013
Nov 9 13
Shire Pharmaceuticals Presents at UBS European Conference, Nov-12-2013 . Venue: The Landmark London Hotel, 222 Marylebone Rd, London NW1 6JQ, United Kingdom.
Roche, Astra and Shire Eyes BioMarin
Nov 8 13
Roche Holding AG (SWX:ROG), AstraZeneca PLC (LSE:AZN) and Shire plc (LSE:SHP) can possible make a bid for BioMarin Pharmaceutical Inc. (NasdaqGS:BMRN), possibly as soon as next week, according to market sources.