Critical Therapeutics, Inc. Files Controlled Release Formulation Of Zileuton

LONDON, Aug. 1 /PRNewswire-FirstCall/ -- SkyePharma PLC announces that its partner Critical Therapeutics Inc has submitted a New Drug Application to the US Food & Drug Administration for a controlled-release formulation of the oral anti- inflammatory drug zileuton for asthma in adults and children aged 12 years or older. The new formulation only needs to be taken twice a day whereas Zyflo(R), the currently marketed version of zileuton, has the drawback of requiring dosing four times a day.

A four times a day immediate-release version of zileuton was marketed by Abbott Laboratories (“Abbott”) as Zyflo(R) Filmtab(R) (zileuton tablets). SkyePharma developed a controlled-release formulation of zileuton, using its Geomatrix(TM) technology, for Abbott, which completed Phase III development in asthma with this product. CTI acquired the rights to zileuton from Abbott and since December 2003 SkyePharma has collaborated with CTI on the further development of this formulation. SkyePharma will receive a single-digit royalty on CTI’s sales of the controlled-release formulation of zileuton and will also manufacture the product for CTI at its plant in Lyon, France.

Frank Condella, Chief Executive of SkyePharma, said: “We are pleased that this successful collaboration with CTI has now culminated in the filing of this version of zileuton, another example of the power of our Geomatrix(TM) technology. Our partner expects this product to reach the market in the second half of next year when it will become another source of royalty and manufacturing income for SkyePharma.”

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

About Critical Therapeutics

Critical Therapeutics, Inc. is a biopharmaceutical company focused on critical care medicine. CTI’s mission is the discovery, development and commercialization of novel therapies for the treatment of acute trauma, cardiopulmonary disease and infectious and inflammatory illness. The Company is headquartered in Cambridge, Massachusetts. More information about CTI is available at

About zileuton

Zileuton is a highly potent oral anti-inflammatory drug. It works by inhibiting the enzyme 5-lipoxygenase. This enzyme, which is involved in the formation of leukotrienes, is a key part of the inflammatory cascade that follows allergic challenge. Inhibition of this enzyme therefore helps minimise bronchoconstriction and mucus secretion in asthma. In its pivotal trials in adult asthma, zileuton was shown to bring the greatest benefit to those with the most severe disease. Zileuton is not intended for acute relief of asthma symptoms but chronic treatment with zileuton allows reduction of other therapies such as oral steroids which have undesirable side-effects.

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: SkyePharma PLC, +44-207-491-1777, or Frank Condella, ChiefExecutive Officer, or Peter Laing, Director of Corporate Communications,+44-207-491-5124, or Sandra Haughton, US Investor Relations,+1-212-753-5780 ; Tim Anderson, or Mark Court, or Rebecca Skye Dietrich,all of Buchanan Communications, +44 207 466 5000