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 June, 2006
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 21 June 2006
SkyePharma Business Review Day 2006
LONDON, UK, 21 June 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces
today that it is holding a Business Review meeting. This meeting (which is being
webcast on SkyePharma's website live at 09.30 a.m. (BST) www.skyepharma.com) is
taking place at the offices of Buchanan Communications (45 Moorfields London
EC2).
Frank Condella, SkyePharma's Chief Executive, said: "I welcome the opportunity
to review our expanding portfolio of marketed products, our near-term and
early-stage pipeline of products that we have developed for subsequent
out-licensing and also our family of delivery technologies. With our Injectables
business unit scheduled for divestment, this will provide an excellent
opportunity for investors to learn more about our core business of oral and
inhalation products."
Frank Condella is providing the Introduction on SkyePharma's strategy. As
previously announced, SkyePharma has decided to concentrate on oral and
inhalation products and to divest its injectable business interests. The
proposed divestment is expected not only to release cash but also to relieve the
Company of a significant cash burn and future capital expenditure. The residual
core business is also expected be able to achieve profitability in the near
term. Furthermore, with greater focused resources the Company expects to be in a
better position to further develop its pipeline of oral and inhalation products.
Ultimately, it is the Company's strategy to add a niche sales and marketing
capability in one or more markets that would improve profit growth and give it
greater control over revenue generation. This section contains information on
the Injectables business that is being divested, including clinical and market
potential data on DepoBupivacaine™, SkyePharma's novel sustained-release
injectable formulation of the local anaesthetic bupivacaine for control of
post-operative pain. DepoBupivacaine™ has completed Phase II trials and is
expected to commence its Phase III trial programme later this year. Frank is
also reviewing the portfolio of sustained-release injectable formulations of
protein and peptide drugs.
Dr Werner Enz, SkyePharma's Vice-President - Commercial, is reviewing
SkyePharma's currently marketed products. These include Paxil CR™, SkyePharma's
improved formulation of GlaxoSmithKline's antidepressant Paxil® (paroxetine);
Xatral® OD (Uroxatral® in the USA), a once-daily version of Sanofi-Aventis's
Xatral® (alfuzosin), a treatment for the urinary symptoms of benign prostatic
hypertrophy; and Solaraze®, SkyePharma's topical gel treatment for actinic
keratosis, now marketed in the US by the Doak Dermatologics unit of Bradley
Pharmaceuticals and in Europe and certain other territories by Shire
Pharmaceuticals. Dr Enz is accompanied by Patrick Fourteau, Chief Executive of
Sciele Pharma, Inc, (the new name for First Horizon Pharmaceutical Corporation),
who is presenting information on Triglide™, SkyePharma's novel formulation of
fenofibrate for the treatment of lipid disorders, which is marketed in the US by
Sciele. Mr Fourteau is also presenting on the controlled release formulation
that SkyePharma is developing for Sciele of its lead product Sular®
(nisoldipine), which is expected to reach the market in 2008.
Dr Francesco Patalano, Managing Director of SkyePharma AG, is reviewing
SkyePharma's near-term and pre-approval pipeline. This includes Pulmicort®
HFA-MDI, a non-CFC aerosol inhaler containing the inhaled steroid budesonide for
asthma, developed for AstraZeneca and approved in its first market in Europe
earlier this year; Requip Once-a-day, a new controlled release oral formulation
of Requip®, GlaxoSmithKline's treatment for Parkinson's disease, filed at the
end of 2005; a new controlled release formulation of Zyflo® (zileuton),
Critical Therapeutics' oral treatment for severe asthma, due to be filed
shortly; and Nitec's Lodotra™, a novel approach to the treatment of rheumatoid
arthritis that uses SkyePharma's GeoClock™ technology to deliver the active
ingredient at the most appropriate time of day. This product, previously
undisclosed, has recently completed Phase III and is expected to be filed later
this year.
Dr Geraldine Venthoye, the head of SkyePharma's Inhalation Business Unit, is
reviewing Foradil® Certihaler™, a new version of Novartis bronchodilator
Foradil® based on SkyePharma's novel multi-dose dry-powder inhaler, the
SkyeHaler™. Foradil® Certihaler™ has now been approved in more than 20
countries and has an "approvable" letter from the FDA. The product was launched
in Germany and Switzerland in September 2005 but a recall from these markets was
initiated in January 2006 because of concerns that accidental mishandling of the
device had resulted in inaccurate dosing in a small number of cases. SkyePharma
is collaborating with Novartis and the relevant health authorities to
investigate the reasons and the actions necessary before the product can be
returned to the market. In the US, the FDA issued an "approvable" letter for
Foradil® Certihaler™ in April 2006 but the FDA is requiring device
modification as a prerequisite for approval.
Dr Ken Cunningham, Chief Operating Officer, is reviewing Flutiform™, a
fixed-dose combination of the long-acting bronchodilator formoterol and the
inhaled steroid fluticasone in a metered-dose aerosol inhaler (MDI) using a
hydrofluoroalkane (HFA) propellant. This is expected to be the third entrant to
the fast-growing US market for combination treatments for asthma and COPD. The
Phase III trial of Flutiform™, started in February 2006, is on track for the
target of filing in the second half of 2007 and US market entry in early 2009.
Dr Cunningham's review includes a video interview with Professor Peter Barnes,
one of the leading authorities in the field of respiratory disease, and a
contribution from Adrian Adams, the President and Chief Executive of Kos
Pharmaceuticals, recently appointed as SkyePharma's US licensee and development
partner for Flutiform™.
Dr Guy Vergnault, head of SkyePharma's Oral Delivery Business Unit, and Dr
Venthoye are reviewing SkyePharma's oral and inhalation delivery technologies.
Dr Vergnault is focussing on the GeoClock™ and solubilisation technologies and
Dr Venthoye on SkyePharma's family of inhalation devices and associated
formulation technologies.
Dr Cunningham is reviewing the early-stage pipeline. This includes two
previously undisclosed oral products: SKLP-132, a fixed-dose combination of an
opioid analgesic and a non-steroidal anti-inflammatory for moderate to severe
pain; and SKP-1041, a non-benzodiazepine hypnotic in a novel delivery
formulation for the maintenance of sleep. Both of these products address
substantial market opportunities.
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, 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 / Rebecca Skye Dietrich
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading
drug delivery technologies that provide easier-to-use and more effective drug
formulations. There are now twelve approved products incorporating SkyePharma's
technologies in the areas of oral, injectable, inhaled and topical delivery,
supported by advanced solubilisation capabilities. For more information, visit
www.skyepharma.com.
Certain statements in this news release are forward-looking statements and are
made in reliance on the safe harbour provisions of the U.S. Private Securities
Litigation Act of 1995. Although SkyePharma believes that the expectations
reflected in these forward-looking statements are reasonable, it can give no
assurance that these expectations will materialize. Because the expectations are
subject to risks and uncertainties, actual results may vary significantly from
those expressed or implied by the forward-looking statements based upon a number
of factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. Factors that could cause differences between actual results and
those implied by the forward-looking statements contained in this news release
include, without limitation, risks related to the development of new products,
risks related to obtaining and maintaining regulatory approval for existing, new
or expanded indications of existing and new products, risks related to
SkyePharma's ability to manufacture products on a large scale or at all, risks
related to SkyePharma's and its marketing partners' ability to market products
on a large scale to maintain or expand market share in the face of changes in
customer requirements, competition and technological change, risks related to
regulatory compliance, the risk of product liability claims, risks related to
the ownership and use of intellectual property, and risks related to
SkyePharma's ability to manage growth. 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: June 21, 2006