SKP28 Sep 2011 17:27
SkyePharma Announces Submission of New Drug Application in the United States for Lodotra® for the treatment of Rheumatoid Arthritis
LONDON, UK, 28 September, 2011 - SkyePharma PLC (LSE: SKP) today announces that its licensee, Horizon Pharma, Inc ("Horizon"), has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Lodotra® for the treatment of active rheumatoid arthritis (RA).
Lodotra® utilises SkyePharma's Geoclock™ technology to provide a proprietary delayed-release formulation of low-dose prednisone. Prednisone is currently FDA-approved for RA and commonly used to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA.
SkyePharma is entitled to a low-mid single digit percentage royalty on net sales of Lodotra® in North America and a mid-single digit percentage royalty elsewhere. Lodotra® is manufactured at the Lyon Manufacturing Facility recently leased by the Group to Aenova.
The Lodotra® NDA submission was primarily based on results from the Circadian Administration of Prednisone in RA (CAPRA-2) trial, a pivotal, 12-week, double-blind, placebo-controlled Phase 3 trial involving 350 RA patients. Both treatment groups in the trial continued to receive standard of care RA treatment with a disease-modifying anti-rheumatic drug (DMARD). Horizon has announced that the results from CAPRA-2 demonstrated:
· A statistically significant improvement in American College of Rheumatology 20 (ACR20) response criteria, the primary study endpoint, for patients who were treated with Lodotra® compared with the placebo group (48.5% vs. 28.6%; p-value = 0.0002)
· A statistically significant improvement in ACR50 response compared with placebo (22.7% vs. 9.2%; p-value = 0.0027) and an improvement in the more stringent ACR70 response criteria (7.0% vs. 2.5%; p-value = 0.0955)
· A statistically significant reduction in morning stiffness compared with patients in the placebo group (56.5% vs. 33.3%; p-value = 0.0008)