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, 2005
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- _______
FOR IMMEDIATE RELEASE
28 April, 2005
SkyePharma PLC
SkyePharma and GlaxoSmithKline
Reach Agreement on Payment of Royalties for Paxil CR™
LONDON, ENGLAND, 28 April, 2005 -- SkyePharma PLC (Nasdaq: SKYE;
LSE: SKP) announces today that it has entered into an amendment agreement with
GlaxoSmithKline ("GSK") in respect of Paxil CR™. Under the terms of the
amendment agreement, GSK will make a one-time payment of approximately $10
million. In addition, SkyePharma will also be entitled to an increase in the
royalty rate from 3% to 4% on actual net sales of Paxil CR™, with effect
from 4 March 2005. As GSK has been unable to supply Paxil CR™ in the US
since 4 March 2005, GSK has also agreed to pay SkyePharma the same level of
royalty on GSK's budgeted sales of Paxil CR™ from 4 March 2005 while the
product remains off the market, subject to other terms of the agreement.
Michael Ashton, SkyePharma's Chief Executive, said: "The royalties from Paxil
CR™ are currently the single most important income flow for SkyePharma. We
are therefore delighted that GSK has agreed to continue the royalty payment as
if supply was maintained. We look forward to continuing our work together with
GSK on this and other product collaborations."
On 4 March 2005, the US Food & Drug Administration ("FDA") halted
distribution of supplies of Paxil CR™ and another unrelated product at
GSK's manufacturing plant at Cidra in Puerto Rico and distribution depots,
thereby halting US distribution of Paxil CR™. Both GSK and the FDA agreed
at the time that manufacturing issues cited by the Agency posed no significant
safety issue for patients. GSK is working with the FDA to resolve these
manufacturing issues as quickly as possible.
For further information please contact:
SkyePharma PLC
+44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications
+44 207 491 5124
Sandra Haughton, US Investor Relations
+1 212 753 5780
Buchanan Communications
+44 207 466 5000
Tim Anderson / Mark Court
Notes to Editors
About SkyePharma
SkyePharma PLC uses its world-leading drug delivery technology to develop
easier-to-use and more effective formulations of drugs. The majority of
challenges faced in the formulation and delivery of drugs can be addressed by
one of the Company's proprietary technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
For more information, visit www.skyepharma.com.
About Paxil CR™
In March 1996, SkyePharma entered into a License Agreement with SmithKline
Beecham (now part of GlaxoSmithKline) for the development, manufacture and
marketing of a modified release version of Paxil®/Seroxat® (paroxetine
hydrochloride) using a combination of SkyePharma's Geomatri™ Positioned
Release and Zero Order systems. Paxil® is an FDA-approved antidepressant
drug that is currently marketed primarily in the United States and Europe (where
it is known as Seroxat®) and is an immediate release formulation prescribed
for central nervous system disorders. Paxil CR™ was approved by the FDA in
February 1999 for the treatment of depression. Subsequently Paxil CR™ has
been approved by the FDA for four additional indications: panic disorder, the
continuous treatment of Pre-Menstrual Dysphoric Disorder (PMDD), social anxiety
disorder and the intermittent treatment of PMDD.
Except for the historical information herein, the matters discussed in this
news release include forward-looking statements that may involve a number of
risks and uncertainties. Actual results may vary significantly based upon a
number of factors, which are described in SkyePharma's 20-F and other documents
on file with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, SkyePharma's marketing partners' ability to market a
pharmaceutical product on a large scale and manage their sales and marketing
organisation and maintain or expand sales and market share for its products,
risks relating to the ability to ensure regulatory compliance, risks related to
the research, development and regulatory approval of new pharmaceutical
products, risks related to research and development costs and capabilities,
market acceptance of and continuing demand for SkyePharma's products and the
impact of increased competition, risks associated with anticipated top and
bottom line growth and the possibility that upside potential will not be
achieved, competitive products and pricing, and risks associated with the
ownership and use of intellectual property rights. SkyePharma undertakes no
obligation to revise or update any such forward-looking statement to reflect
events or circumstances after the date of this release.
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/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: April 28, 2005