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- _______
Once-Daily REQUIP™ 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 GeomatrixTM 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).
END
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 23, 2007