SKP.L Regulatory News (SKP)

11 Aug 2006 07:01

Skyepharma PLC11 August 2006 For Immediate Release 11 August 2006 SkyePharma PLC Statement Regarding Recent Share Price Movement LONDON, UK, 11 August 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) notes therecent decline in the Company's share price and confirms that it is not aware ofany fundamental reason for this decline. Frank Condella, SkyePharma's Chief Executive Officer, said: "We are disappointedby the fall in our share price over the past few weeks. We are continuing ourefforts to deliver on the strategy outlined earlier this year to divest ourinjectable unit and to out-license Flutiform(TM) outside the US and we remainconfident that we will be able to achieve these objectives. We are pleased bythe support of our major shareholders who have maintained their shareholdingsduring this period." Earlier this year the Board decided to divest the injectables unit, a stand-alone operation with its own management team, R&D and manufacture in San Diego.UBS, the investment bank appointed for this disposal, is managing the process.Discussions are continuing with interested parties and also with certaincompanies that have expressed an interest in DepoBupivacaine(TM) alone or inother assets. The Company is progressing with several options, all of which aregeared towards bringing in cash and reducing the ongoing cash burn. The Companycontinues to expect to complete a transaction before the end of the year. For key pipeline products, the Phase III trials of Flutiform(TM) are proceedingand remain on track for the Company's target of filing this key product with theUS Food & Drug Administration ("FDA") in the second half of 2007. SkyePharmanotes the recent FDA approval of AstraZeneca's combination asthma productSymbicort(R) and is encouraged by the speed with which this product wasreviewed and approved, increasing confidence that the Company's previousexpectation of a US market launch for Flutiform(TM) in 2009 is reasonable orpossibly conservative. Having now appointed Kos Pharmaceuticals as the licenseefor Flutiform(TM) in the US market, the Company is engaged in late-stagenegotiations for other key markets. With its partner Novartis, the Company has successfully completed modificationsto its dry powder inhaler device to prevent mishandling that it is hoped willallow Foradil(R) Certihaler(TM) to be returned to the market in Europe and toobtain approval in the USA. The modified product is currently being reviewed bythe FDA and a decision is expected before the end of the year. In addition to the above, the Company is cognisant of the longer termrequirement to grow the business. Besides Flutiform(TM), there are a number ofearly-stage projects under active consideration. Following a planning meetingscheduled for September, the Company expects to be in a position to outline itsstrategic plans in more detail. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications 44 207 491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court / Rebecca Skye Dietrich About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now twelve approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances after the date of this release. This information is provided by RNS The company news service from the London Stock Exchange