Regulatory Application

23 Mar 2009 07:00



SkyePharma Announces Filing of New Drug Application  

for Flutiform™ to the FDA

Primary endpoints were met in all of the clinical programmes required for the submission of the NDA, comprising a long-term safety study and four efficacy studies, covering nearly 2,300 patients.

Flutiform™ HFA-MDI is a fixed-dose combination of an inhaled corticosteroid (ICS) fluticasone and formoterol, long-acting beta agonist (LABA) in a metered dose inhaler.  ICS/LABA combinations are the fastest growing segment of the global asthma/COPD market, which was worth an estimated U.S. $28.8 billion in 2007 globally.

Dr. Ken Cunningham, CEO of SkyePharma said, "The submission of the NDA for Flutiform™ is a major milestone for SkyePharma. We believe that Flutiform™, when approved, will provide physicians and asthma patients with an additional treatment option to better manage this serious, chronic condition." 

SkyePharma will announce its results for the year ended 31 December 2008 on 26th March 2009.

For further information please contact: 

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

About Flutiform™

Flutiform™ HFA-MDI is a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler ("MDI"). The product incorporates the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a fast onset long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane ("HFA") and is being developed for asthma. Flutiform™ is licensed in the U.S. to Abbott Respiratory LLC (formerly known as Kos Life Sciences, Inc.), a wholly owned subsidiary of Abbott.