Skyepharma PLC To Develop Improved Controlled Release Version Of Sular For First Horizon Pharmaceutical Corp.

LONDON, May 22 /PRNewswire-FirstCall/ -- SkyePharma PLC (Nasdaq: SKYE - News; LSE: SKP - News) announces that it has entered into an agreement with First Horizon Pharmaceutical Corporation (“First Horizon”) (Nasdaq: FHRX - News) to develop a novel controlled-release version of Sular (nisoldipine), an antihypertensive that is First Horizon’s largest product. First Horizon’s cardiovascular and metabolic product portfolio sales amounted to $145 million in 2005. The SkyePharma version is designed to have an improved pharmacokinetic profile and is expected to replace the current version and to expand the market opportunity for Sular.

Frank Condella, SkyePharma’s Chief Executive Officer, said: “SkyePharma’s core competency is the development of improved formulations of existing products. This new agreement reinforces our activities in this area now that we are focusing on our core business of oral and inhalation products. We are also pleased to expand our collaboration with First Horizon, a fast growing US pharmaceutical company.”

SkyePharma will receive a mid-single digit royalty on net sales of Sular CR. SkyePharma will also receive a total of up to $5 million in milestone payments. $1 million has been paid at signing and up to $4 million will be paid conditional on obtaining approval by the US Food & Drug Administration (“FDA”), which is expected in 2008. SkyePharma may manufacture and supply the product from its Lyon manufacturing facility. First Horizon will fund all of SkyePharma’s development costs for Sular CR and will market this product through its speciality sales force (currently 525 representatives of whom 450 are focused on primary care physicians).

Nisoldipine, the active ingredient in Sular, is an antihypertensive agent used to reduce blood pressure. It is estimated that 65 million Americans (nearly one quarter of the population) currently have elevated blood pressure, a recognised risk factor for stroke and heart attacks, and this number is increasing from demographic factors as the post-war “Baby Boom” reaches middle age. 60% of those affected are diagnosed and receive treatment but only half of those treated attain treatment goals so there is a recognised opportunity for better treatments. Nisoldipine is a calcium channel blocker that prevents calcium from entering certain types of muscle cells. Because muscle cells need calcium to contract, calcium channel blockers prevent the cells from contracting and cause them to relax. Nisoldipine selectively relaxes the muscles of small arteries causing them to dilate but has little or no effect on muscles or the veins of the heart.

For further information please contact:

SkyePharma PLC Frank Condella, Chief Executive +44 207 491 1777 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

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

About First Horizon

First Horizon is a leading US specialty pharmaceutical company that acquires, develops and markets prescription medicines within its chosen therapeutic areas of cardiovascular, obstetrical and gynaecological, paediatric and gastroenterological conditions and disorders. Since 1992, First Horizon has introduced 17 products. First Horizon promotes its products through its nationwide sales and marketing force of more than 500 professionals. For more information, visit

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.

Source: SkyePharma PLC