Skyepharma PLC - Once-Daily Requip (ropinirole HCl) XL 24-Hour Extended-Release Tablets Accepted for Filing by U.S. FDA
Once-Daily Requip (ropinirole HCl) XL 24-Hour Extended-Release Tablets Accepted for Filing by U.S. FDA
LONDON, April 13, 2007 - SkyePharma PLC (LSE:SKP; NASDAQ: SKYE) today announces that the United States Food and Drug Administration has accepted for filing the application by its partner, GlaxoSmithKline (NYSE: GSK), for Requip XL 24-Hour Extended-Release Tablets, the proposed brand name for a once-daily formulation of ropinirole for treating Parkinson's disease. It has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours.
Ropinirole is a non-ergot dopamine agonist currently marketed as
Requip (ropinirole HCl) Tablets, an immediate-release
formulation. It has an indication in the U.S. for the treaent of
the signs and symptoms of idiopathic Parkinson's disease and is
administered three times a day. Requip XL 24-Hour uses SkyePharma's
proprietary GeoMatrix technology and has been designed to be given
once daily and to have a simpler and faster titration
On 3 April 2007, GlaxoSmithKline announced positive results of the Ropinirole 24-Hour Efficacy and Safety Evaluation in PD-Adjunct (EASE-PD Adjunct) study, which were published in the 3 April issue of Neurology. In that study, adding Requip XL 24-Hour once daily to Parkinson's patients' existing levodopa (L-dopa) therapy significantly reduced 'off' time by an average of more than 2 hours per day when compared with baseline prior to treaent, thus allowing these patients to continue their daily activities for a longer period of time.
Requip is indicated for Parkinson's disease and Restless Legs Syndrome in the U.S. Parkinson's disease makes up about 40 percent of current Requip sales in the U.S. If approved for Parkinson's disease, future sales of Requip XL 24-Hour will generate low mid-single digit royalties for SkyePharma.
Parkinson's disease is a chronic, progressive and debilitating neurological condition that impairs the body's ability to move and balance. Researchers have determined that Parkinson's disease involves pathways in the brain responsible for motor control that are functioning improperly. Patients with Parkinson's disease experience a reduction in dopamine, a key chemical in the brain that communicates messages about movement, resulting in the symptoms of Parkinson's disease. These symptoms may include bradykinesia (slower-than-normal voluntary movements), rigidity (stiffness), tremor (involuntary shaking) and postural instability (trouble with balance).
More than one million people in the United States have Parkinson's disease, and it is estimated that nearly 60,000 new cases are diagnosed in the U.S. each year. Most people develop Parkinson's disease between the ages of 40 and 70, but the disease can also develop at an earlier age.
Commenting on today's announcement, Frank Condella, CEO of SkyePharma, said:
'This is an important step towards gaining approval in the US for Requip XL 24-Hour which we believe has the potential to be a significant product for SkyePharma. Dopamine agonists are increasingly recommended by doctors as a first-line therapy for patients suffering from Parkinson's disease and this new, once-daily version of Requip could deliver significant benefits for these patients and may improve compliance.'
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Financial Dynamics (UK
+44 20 7831 3113
Trout Group (US
+1 617 583 1308
GSK European Analyst/Investor
+44 20 8047 5542
Sally Ferguson +44 20 8047 5543
David Mawdsley +44 20 8047 5564
NOTES TO EDITORS
About the EASE-PD Study
The EASE-PD Adjunct study was a multi-center, double-blind,
placebo-controlled study, conducted in patients with idiopathic
Parkinson's disease not adequately controlled with L-dopa.
Subjects were randomized (1:1) to receive Requip XL 24-Hour once
daily (n=202) or placebo (n=191) in addition to L-dopa for 24
weeks. The primary endpoint was mean change from baseline in
awake time spent '
off' (measured via patient diaries). 'Off' time describes the return of Parkinson's symptoms as a patient's medication wears off. Requip XL 24-Hour decreased patients' awake time spent 'off' by an average of 2.1 hours per day, while placebo decreased awake time spent 'off' by 0.3 hours per day compared to baseline prior to treaent.
The study also included a wide variety of motor and non-motor
secondary endpoints, including 'on' time which refers to the time
during which medication is working and providing benefit, and 'on'
time without troublesome dyskinesia which refers to 'on' time
without involuntary movements interfering with
function or causing discomfort, a common problem in Parkinson's disease. Requip XL 24-Hour significantly increased both 'on' time and 'on' time without troublesome dyskinesia by 1.6 hours per day (a greater than 12 percent increase) and reduced the percentage of 'off' time by more than 12 percent compared to baseline. Requip XL 24-Hour also improved sleep problems associated with Parkinson's disease, as measured by the Parkinson's Disease Sleep Scale total score.
There were other motor and non-motor secondary endpoints in the study that were statistically significant. However, there were no significant differences between Requip XL 24-Hour and placebo in PDQ-39 subscales of social support, cognition or bodily discomfort. Additionally, there was no significant difference between Requip XL 24-Hour and placebo on the Epworth Sleepiness Scale total score signifying no increase in daytime sleepiness.
In the EASE-PD Adjunct study, once daily use of Requip XL 24-Hour was generally well tolerated. The withdrawal rate due to adverse events was low and similar between the two groups (Requip XL 24-Hour 5 percent versus placebo 5 percent). The most common adverse events reported in patients taking Requip XL 24-Hour (n=202) versus placebo (n=191) were dyskinesia (13 percent versus 3 percent), nausea (11 percent versus 4 percent), dizziness (8 percent versus 3 percent), somnolence (7 percent versus 4 percent), hallucinations (6 percent versus 1 percent), and orthostatic hypotension (5 percent versus 2 percent).
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma
develops new formulations of known molecules to provide a clinical
advantage and life-cycle extension. The Company has nine approved
products in the areas of oral, inhalation and topical delivery that
are marketed throughout the world by
leading pharmaceutical companies. For more information, visit www.skyepharma.com
GlaxoSmithKline, with U.S. operations in Philadelphia and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and health care companies.
Posted: April 2007