SOURCE: SkyePharma PLC

June 16, 2008 02:08 ET

Skyepharma PLC Announces Regulatory Approval

London, UK--(Marketwire - June 16, 2008) -


FDA APPROVES REQUIP® XL™, THE FIRST AND ONLY ORAL ONCE-DAILY 
NON-ERGOT DOPAMINE AGONIST FOR PARKINSON'S DISEASE

Extended-Release Formulation Improved Symptoms in Patients Not
Optimally Controlled with Levodopa and Reduced Patients'"Off" Time by
Nearly Two Hours Per Day

LONDON, UK, 16 June 2008 -- SkyePharma PLC (LSE: SKP) today announces
that the United States Food and Drug Administration (FDA) has approved
GlaxoSmithKline's (NYSE: GSK) Requip® XL™ (ropinirole 
extended-release tablets).  Requip® XL™ is the first and only 
once-daily oral non-ergot dopamine agonist indicated for Parkinson's
disease. The product is expected to be available in U.S. pharmacies in
mid-July 2008.

The new Requip® XL™ formulation uses SkyePharma's patented 
Geomatrix™ technology. This innovative tri-layer formulation allows
for continuous delivery of ropinirole over 24 hours to provide smooth
blood levels. Extended-release ropinirole offers physicians and
patients a simple titration regimen; it also offers a convenient, once-
daily dosing schedule compared to other oral dopamine agonists, which
are dosed multiple times a day.

Requip® XL™ is currently approved in 23 countries in Europe for 
the treatment of Parkinson's disease. SkyePharma will receive low-mid
single digit royalties on sales.

The pivotal study showed that adding Requip® XL™ to patients'
existing levodopa ("L-dopa") therapy reduced the amount of "off" time
experienced by patients with Parkinson's disease by more than two hours
per day on average, compared with baseline.  "Off" time is experienced
by patients with Parkinson's disease when their medication wears off
and their symptoms return. "Many patients require multiple doses of one
or more medications to control their Parkinson's symptoms, which makes
taking their medicines correctly and at the right times challenging. In
addition, patients with Parkinson's disease may have trouble completing
routine activities of daily living and self-care," said clinical
investigator Rajesh Pahwa, M.D., professor of Neurology and director of
the Parkinson's Disease and Movement Disorder Centre at the University of
Kansas Medical Centre in Kansas City. "Requip® XL™ provides
continuous delivery of ropinirole over 24 hours to provide smoother blood
levels without the peaks and troughs that multiple daily doses typically
deliver. It is an important once-daily treatment option for patients
with Parkinson's disease."

Frank Condella, Chief Executive Officer of SkyePharma added: "We are
delighted by today's FDA approval of Requip® XL™ which uses our
unique Geomatrix™ technology. This represents yet another successful
collaboration between SkyePharma and GSK and demonstrates the clinical
value of our drug delivery technologies."

FDA approval was based primarily on results from the EASE-PD (Efficacy
And Safety Evaluation in Parkinson Disease) Adjunct Study, a
multi-centre, double-blind, placebo-controlled study conducted in
patients with idiopathic Parkinson's disease not adequately controlled
with L-dopa. A total of 393 patients in the study were randomized to
receive either extended-release ropinirole (n=202) or placebo (n=191)
once daily for 24 weeks, in addition to 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. Results from the
study showed 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. 


Once-daily use of extended-release ropinirole was generally well
tolerated in the study. The withdrawal rate due to adverse reactions
was low and similar between groups (6 percent extended-release
ropinirole vs. 5 percent placebo). The most common adverse reactions
reported in patients taking extended-release ropinirole compared
with placebo were dyskinesia (13 percent vs. 3 percent), nausea (11
percent vs. 4 percent), dizziness (8 percent vs. 3
percent), hallucination (7 percent vs. 3 percent), somnolence (7
percent vs. 4 percent), abdominal pain/discomfort (6 percent vs. 3
percent) and orthostatic hypotension (5 percent vs. 1 percent). 


For further information please contact: 


SkyePharma PLC                    Frank Condella    +44 20 7491 1777 
During office hours               Ken Cunningham
                                  Peter Grant
Financial Dynamics (UK Enquiries) David Yates       +44 20 7831 3113
Outside office hours              Deborah Scott
Trout Group (US Enquiries)        Christine Labaree +1 617 583 1308
                                  Seth Lewis


About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops
new formulations of existing products to provide a clinical advantage
and life-cycle extension. The Company has twelve approved products in
the areas of oral, inhalation and topical delivery. The Group's
products are marketed throughout the world by leading pharmaceutical
companies. For more information, visit www.skyepharma.com.


About GlaxoSmithKline

Requip® XL™ was developed and is marketed by GlaxoSmithKline, one
of the world's leading research-based pharmaceutical and healthcare
companies. For more information regarding Requip® XL™, please see
the Complete Prescribing Information available at www.gsk.com. More
information on GlaxoSmithKline is available at the company's website
at www.gsk.com.  



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