SkyePharma PLC: Flutiform NDA Accepted for Review

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 USUSD10
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 USUSD2
million (GBP1.3 million) is due to SkyePharma from which the filing fee
of USUSD1.2 million (GBP0.8 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

Ken Cunningham, Chief Executive Officer +44 207 491 1777

Peter Grant, Chief Financial Officer

Financial Dynamics

Jonathan Birt                           +44 207 831 3113

Susan Quigley


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.



                    This information is provided by RNS
          The company news service from the London Stock Exchange

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