22 May 2009 07:00
SKYEPHARMA PLC - Flutiform™ NDA Accepted for Review
LONDON, UK, 22 May 2009 - SkyePharma PLC (LSE: SKP) today announces that the New Drug Application (NDA) for its lead development product, Flutiform™ (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older, has been accepted for review by the US Food and Drug Administration (FDA).
If approved, Flutiform™ will be the first ever fixed-dose medication combining fluticasone, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta agonist (LABA), in the US. Using an environmentally-friendly aerosol propellant, hydrofluoroalkane (HFA), in a metered-dose inhaler, Flutiform™ is aimed at the combination ICS/LABA inhaler market, which is forecast to generate approximately US$10 billion worldwide by 2010.
As previously announced, the NDA for Flutiform™ was submitted to the FDA in Q1 2009. The acceptance of the filing means the FDA has determined that the NDA is sufficiently complete to permit a substantive review. The regulatory review timeline for asthma treatments is typically longer than the standard 10-month Prescription Drug User Fee Act (PDUFA) timeline.
Following the acceptance of the NDA for review, an amount of US$2 million (£1.3 million) is due to SkyePharma from which the filing fee of US$1.2 million (£0.8 million) will be deducted.
Dr. Ken Cunningham, CEO of SkyePharma, said "We are pleased that the FDA has accepted the Flutiform™ NDA for review. This is a further step in the development of Flutiform™. We believe that, if approved, Flutiform™ will provide physicians and asthma patients with an important additional treatment option to help manage this serious, chronic condition."
For further information please contact:
| SkyePharma PLC |
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| Ken Cunningham, Chief Executive Officer | +44 207 491 1777 |
| Peter Grant, Chief Financial Officer |
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| Financial Dynamics |
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| Jonathan Birt | +44 207 831 3113 |
| Susan Quigley |
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About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Group 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 long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (HFA) and is being developed for asthma. The rights for commercialisation of Flutiform™ in the U.S. are licensed to Abbott Respiratory LLC, a wholly-owned subsidiary of Abbott.