LONDON, Aug. 11 /PRNewswire-FirstCall/ -- SkyePharma PLC notes the recent decline in the Company’s share price and confirms that it is not aware of any fundamental reason for this decline.
Frank Condella, SkyePharma’s Chief Executive Officer, said: “We are disappointed by the fall in our share price over the past few weeks. We are continuing our efforts to deliver on the strategy outlined earlier this year to divest our injectable unit and to out-license Flutiform(TM) outside the US and we remain confident that we will be able to achieve these objectives. We are pleased by the support of our major shareholders who have maintained their shareholdings during 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 certain companies that have expressed an interest in DepoBupivacaine(TM) alone or in other assets. The Company is progressing with several options, all of which are geared towards bringing in cash and reducing the ongoing cash burn. The Company continues to expect to complete a transaction before the end of the year.
For key pipeline products, the Phase III trials of Flutiform(TM) are proceeding and remain on track for the Company’s target of filing this key product with the US Food & Drug Administration (“FDA”) in the second half of 2007. SkyePharma notes the recent FDA approval of AstraZeneca’s combination asthma product Symbicort(R) and is encouraged by the speed with which this product was reviewed and approved, increasing confidence that the Company’s previous expectation of a US market launch for Flutiform(TM) in 2009 is reasonable or possibly conservative. Having now appointed Kos Pharmaceuticals as the licensee for Flutiform(TM) in the US market, the Company is engaged in late-stage negotiations for other key markets.
With its partner Novartis, the Company has successfully completed modifications to its dry powder inhaler device to prevent mishandling that it is hoped will allow Foradil(R) Certihaler(TM) to be returned to the market in Europe and to obtain approval in the USA. The modified product is currently being reviewed by the FDA and a decision is expected before the end of the year.
In addition to the above, the Company is cognisant of the longer term requirement to grow the business. Besides Flutiform(TM), there are a number of early-stage projects under active consideration. Following a planning meeting scheduled for September, the Company expects to be in a position to outline its strategic plans in more detail.
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 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.
SkyePharma PLC
CONTACT: Frank Condella, Chief Executive Officer, or Peter Laing, Directorof Corporate Communications, +44-207-491-5124, or Sandra Haughton, USInvestor Relations, +1-212-753-5780, all of SkyePharma PLC,+44-207-491-1777; or Tim Anderson, or Mark Court, or Rebecca Skye, all ofDietrich Buchanan Communications +44-207-466-5000
Web site: http://www.skyepharma.com/
