SkyePharma Plc (SKP.L, SKYEF.PK,SKYEY.PK) said Monday that the U.S. Food and Drug Administration or FDA has approved Requip XL, a drug developed by GlaxoSmithKline Plc's (GSK, GSK.L) for the treatment of Parkinson's disease. SkyePharma would receive low-mid single digit royalties on sales of the product, which is expected to hit the U.S. market in mid-July 2008.
The London, U.K.-based SkyePharma noted that Requip XL or ropinirole extended-release tablets, currently approved in 23 countries in Europe, are the first and only once-daily, oral, non-ergot dopamine agonist indicated for the disease. The new formulation uses its patented Geomatrix technology, a tri-layer formulation, which allows a 24-hours continuous delivery of the medicine to provide smooth blood levels.
SkyePharma stated that the FDA approval was based principally on results from an Efficacy And Safety Evaluation in Parkinson Disease Adjunct Study. The multi-center, double blind, placebo-controlled study was conducted in 393 patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. The study's primary endpoint was the mean change from baseline at week 24 in awake time spent "off," which was measured via patient diaries.
The results demonstrated that extended-release ropinirole significantly reduced "off" time by an average of 2.1 hours per day from baseline, compared with a reduction of 0.4 hours per day for placebo. The study also showed that the once-daily use of ropinirole was generally well tolerated, and that the withdrawal rate due to adverse reactions was low and similar between groups. SKP.L is currently trading on the LSE at 6.1120 pence, up 0.6120 pence, or 11.13%, on a volume of 749,076 shares.
GSK.L is trading currently on LSE at 1.088.80 pence, rising 13.00 pence, or 1.21%, with a volume of 1.9 million shares.
GSK closed trading on Friday at $42.04, up $0.44, or 1.06%, with a volume of 1.34 million shares.
SKYEY.PK closed Friday's trading at $1.00, down $0.01, or 0.99%.
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