SkyePharma PLC - Annual General Meeting Statement
28 Juin 2006 - 2:31PM
PR Newswire (US)
LONDON, June 28 /PRNewswire-FirstCall/ -- The Annual General
Meeting of SkyePharma plc (LSE:SKPLSE:Nasdaq:LSE:SKYE) was held in
London today. All resolutions were passed, with the minimum support
level of 99%. Three directors are retiring; Michael Ashton, Sir
Michael Beavis and Dr Keith Mansford, have not stood for
re-election and were thanked for their contribution. Non-Executive
Chairman Dr Argeris "Jerry" Karabelas made the following comments
to shareholders: "Earlier this year, a strategic review of the
company was completed. This led to a six-point strategic plan. We
were gratified that the Extraordinary General Meeting in March
supported this new strategic direction for the company. 1. Appoint
new leadership SkyePharma's founder Ian Gowrie-Smith resigned from
the Board in January and I was appointed Non-executive Chairman in
his place. A new executive management team has also been appointed
this year with Frank Condella as Chief Executive and Dr Ken
Cunningham as Chief Operating Officer. Both have since joined the
Board. 2. Divest the injectables unit The injectables unit is a
stand-alone operation with its own management team and R&D and
manufacture in San Diego. SkyePharma's Board has concluded that the
unit requires significant investment in R&D and capital
expenditure before it can become profitable. Divestment of the
injectables unit is expected to bring a number of benefits,
including improving SkyePharma's profitability and reducing the
cash requirements of the ongoing business, and the cash raised by
divestment should strengthen SkyePharma's balance sheet and permit
the Company to explore strategic options. Furthermore the
divestment will allow management to focus on the core
oral/inhalation unit. UBS has been appointed as investment bank for
this disposal and currently a number of interested parties are
completing due diligence and are in negotiations. We are working to
complete this sale before the end of the year. 3. Continue Phase
III for Flutiform(TM) and out-license this year I am pleased to
report that Flutiform(TM) commenced its Phase III trial in
February, as planned. We have now completed recruitment for the 12
month safety study and the three pivotal studies will commence in
the second half, all on track for our target of filing with the FDA
in the second half of 2007. In May, we announced that we had
granted exclusive marketing rights for Flutiform(TM) in US (with a
right of first negotiation for Canada) to Kos Pharmaceuticals, a US
specialist pharmaceutical company with a highly successful sales
record and experience in the respiratory market. Kos has 750 sales
representatives and this number will increase to over 1000 by the
time that Flutiform(TM) is launched. We are convinced that Kos has
an ideal profile to optimise sales of Flutiform(TM) in the key US
market and we are gratified by their obvious degree of commitment
to the product. This agreement will bring SkyePharma up to $165
million in milestone payments (including $25 million paid on
signature) and a royalty rate that starts in mid-teens and
escalates on sales targets. We will share with Kos the development
of Flutiform(TM) for asthma and COPD: we will manage and fund the
trials needed for approval of Flutiform(TM) in adult asthma while
Kos will manage and fund the trials needed for all other
indications and all marketing and post- approval studies. We remain
in negotiation with other potential partners for Europe, Latin
America, Japan and other territories. 4. Focus on core
oral/inhalation unit and expand pipeline On 21 June SkyePharma held
a Business Review day that focused on the core oral and inhalation
business, we disclosed two new projects about to enter clinical
trials: a treatment for pain and inflammation and a novel approach
to the treatment of sleep disorders. We also announced one new
partnered project (a controlled release version of Sular(R), the
lead product of Sciele Pharma (the new name for First Horizon, our
partner for Triglide(TM)) and reviewed two late-stage products that
had not previously been discussed in detail and which will be filed
later this year: a controlled release version of the oral asthma
drug Zyflo(R) that we have developed for Critical Therapeutics and
Lodotra(TM), a novel controlled release formulation of an
anti-inflammatory drug for rheumatoid arthritis that we have
developed for Nitec. We will be seeking additional complementary
projects to reinforce our pipeline. 5. Improve operational
efficiency Most of SkyePharma's operating cost consists of R&D
expenditure. There is little scope to cut this without prejudicing
the Company's future. However we are determined to save costs where
possible. We have reviewed the rental cost of our London head
office and while this was found to be highly competitive we have
decided to relocate all of the head office staff on a single floor
and sublet the rest of space. This will reduce our rental cost by
nearly half and also avoid the inevitable disruption and cost
incurred by moving to new premises. In the US we will be vacating
our office in New York, which will be sublet. A new small office on
the East Coast is planned once the injectables divestment has been
completed. We have also reviewed overall staffing levels and
reduced the number of personnel at our plant in Lyon. Concluding
remarks I would also like to draw shareholders' attention to
certain recent developments. Our injectable product DepoDur(TM) for
post-operative pain was approved in the UK in May. This approval
will be used as the basis for seeking approval throughout the
European Union. As disclosed in the Annual Report, Foradil(R)
Certihaler(TM) was launched in Germany and Switzerland in September
2005 but was recalled from these markets early this year because of
concerns that accidental mishandling of the device had resulted in
inaccurate dosing in a small number of cases. With our partner
Novartis we have now completed modifications to our dry powder
inhaler device to prevent mishandling that we hope will allow
Foradil(R) Certihaler(TM) to be returned to the market in Europe
and obtain approval in the USA. Finally we have agreed with our US
partner Endo Pharmaceuticals to terminate development of Propofol
IDD-D(TM). We believe that the strategic initiatives we have
adopted will enable the Company to maximise the potential of
Flutiform(TM) and other pipeline products, to become profitable in
the near term and to deliver long-term value for shareholders." 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 develops pharmaceutical products benefiting
from world-leading drug delivery technologies that provide
easier-to-use and more effective drug formulations. There are now
ten 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 http://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. DATASOURCE: SkyePharma plc CONTACT:
Frank Condella, Chief Executive Officer of SkyePharma PLC,
+44-207-491-1777, or Peter Laing, Director of Corporate
Communications, +44-207-491-5124, or Sandra Haughton, US Investor
Relations, +1-212-753-5780; or Tim Anderson, Mark Court, or Rebecca
Skye Dietrich, +44-207-466-5000, all of Buchanan Communications Web
site: http://www.skyepharma.com/
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