SkyePharma PLC (LSE: SKP) today announces
that the US Food and Drug Administration (FDA) has issued a
communication in respect of the New Drug Application (NDA) for its lead
development product, FlutiformTM (fluticasone propionate/formoterol
fumarate), an investigational treatment for persistent asthma in
patients 12 years of age and older.
The communication, known as a 74-day letter, confirms, as previously
announced, that the NDA is sufficiently complete to permit a
substantive review and, in line with standard review practice, the FDA
has given preliminary notice of some potential review issues. The FDA
states that its filing review is only a preliminary evaluation of the
application and is not indicative of deficiencies that may be
identified during its review and that issues may be added, deleted,
expanded upon, or modified as it reviews the application.
Further clarification is required of some of these potential review
issues and steps are being taken to seek discussions with the FDA with
a view to agreeing how they may be addressed. Although the
requirements cannot be precisely assessed prior to discussion with the
FDA, based on a preliminary assessment, it appears likely that some
additional clinical work may be required to provide more data on
As previously announced, the regulatory review timeline for asthma
treatments is typically longer than the standard 10-month Prescription
Drug User Fee Act timeline. Should additional clinical work be
required this is likely to impact on the timeline for the review and
any potential approval.
The potential review issues are not expected to have an impact upon the
development of FlutiformTM for Europe or Japan.
For further information please contact:
Ken Cunningham, Chief Executive Officer
Peter Grant, Chief Financial Officer
+44 207 491 1777
+44 207 831 3113
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.
FlutiformTM 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 FlutiformTM in
the U.S. are licensed to Abbott Respiratory LLC, a wholly-owned
subsidiary of Abbott.