London, UK -- (MARKET WIRE) -- April 23, 2007 --
Once-Daily REQUIP(TM) LP Extended-Release Tablets Approved in France
LONDON, UK, Monday, April 23, 2007 - SkyePharma PLC (LSE:SKP; NASDAQ: SKYE)
today announces that regulatory approval has been received in France for
ropinirole prolonged release tablets (which will be marketed as REQUIP™ LP
(1) in France). The new prolonged release tablet of ropinirole is taken once
daily, and is indicated for the treatment of Parkinson's disease (PD).
SkyePharma's partner for the product, GlaxoSmithKline has also received approval
in Slovakia, Slovenia, Latvia, Estonia and Canada, and plans to gain further
marketing authorisations in other countries.
On 13 April, SkyePharma announced that the United States Food and Drug
Administration had accepted for filing the application by GSK for approval to
market the product in the US. REQUIP™ LP has been designed to provide a
steady rate of absorption in the body to help reduce blood plasma fluctuations
over 24 hours.
Frank Condella, CEO of SkyePharma, commented: "We are pleased to announce the
French approval of REQUIP™ LP, a significant step in the roll-out of
ropinirole prolonged release tablets across the Continent. In the coming
months, we expect to gain additional European approvals and will continue the
roll-out of this important product across other member states of the European
Union."
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
NOTES TO EDITORS
About Ropinirole
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™ LP uses
SkyePharma's proprietary Geomatrix™ technology and has been designed to be
given once daily and to have a simpler and faster titration schedule.
Our partner GSK conducted two pivotal studies to support of the registration of
ropinirole prolonged release tablets in Europe. One study was a ropinirole
monotherapy study in early PD, and the other was an adjunct study with levodopa
(L-dopa) in advanced PD. These studies confirmed the efficacy of ropinirole
prolonged release tablets, in terms of symptomatic control to allow patients to
continue their daily activities.
About Parkinson's Disease
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).
In Europe, an estimated 800,000 people live with PD, with about 75,000 new cases
diagnosed every year.(i) The correct medication is key to helping them maintain
a good quality of life and minimising long-term side effects. As with many
diseases, compliance is a significant barrier to positive patient outcomes in
PD.
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 ten 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.
1. In the other member states of the European Union, the product suffixes
under consideration are REQUIP-MODUTAB™, REQUIP™ XL, or REQUIP DEPOT™.
REQUIP, MODUTAB AND DEPOT are trademarks of the GlaxoSmithKline group of
companies.
i European Federation of Pharmaceutical Industries and Associations: Disease
Burden in Europe.
http://www.efpia.org/Content/Default.asp?PageID=133 (Accessed
April 2007).
This information is provided by RNS
The company news service from the London Stock Exchange