SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of April, 2007
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
Press Announcement
Once-Daily REQUIP® (ropinirole HCl) XL 24-Hour™ Extended-Release Tablets Accepted for Filing by U.S. FDA
LONDON, UK, 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 treatment 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 schedule.
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 treatment, 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
Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group (US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
GSK European Analyst/Investor inquiries: Anita Kidgell +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 treatment.
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
About GlaxoSmithKline
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.
About REQUIP Tablets (Immediate-Release Formulation)
Prescription REQUIP is not for everyone. REQUIP Tablets may cause patients to fall asleep or feel very sleepy during normal
activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if
they experience these problems or if they drink alcohol or are taking other medicines that make them drowsy. Patients should also
tell their doctor if they or their family notices that they develop any unusual impulses or behaviors, such as pathological gambling
or hypersexuality. Hallucinations may occur at anytime during treatment. REQUIP may potentiate the side effects of L-dopa. Side
effects include nausea, dizziness, drowsiness or sleepiness, headache, and dyskinesia (uncontrolled movements). Most patients were
not bothered enough to stop taking REQUIP. This is not a complete list of side effects and should not take the place of discussions
with patients' healthcare providers. Their doctor or pharmacist can give patients a more complete list of side effects. Patients
should talk to their doctor about any side effects they may have.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that
any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks
and uncertainties that may cause actual results to differ materially from those projected.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ John Murphy
Name: John Murphy
Title:
Company Secretary
Date: April 13, 2007