Marketwire -- -SkyePharma PLC today provides
an update following a meeting held with the US Food and Drug
Administration (FDA) to discuss the previously announced potential
review issues in respect of the New Drug Application (NDA) for its lead
development product, Flutiform(TM) (fluticasone propionate/formoterol
fumarate), an investigational treatment for persistent asthma in
patients 12 years of age and older.
As previously announced, in June 2009 the FDA gave preliminary notice
of some potential review issues which it had identified in its
preliminary evaluation of the NDA, which had been accepted for
substantive review. As a result, the Company announced that it
appeared likely that some additional clinical work may be required to
provide more data on dosing and that a meeting was being sought with
the FDA with a view to agreeing how the potential review issues may be
A meeting has now been held with the FDA and it has been confirmed that
additional clinical work will be required to provide more data on
dosing. The Board believes that it is unlikely that Flutiform(TM) will,
therefore, be approved in the US before the second half of 2011. In
the meantime the review of the NDA is continuing.
Under the current license agreement Abbott is responsible for paying
for additional clinical or other trials required by the FDA, and is
entitled to recoup such costs out of up to 25 per cent. of any approval
or post-approval milestones and royalties.
The potential review issues are not expected to have an impact upon the
development of Flutiform(TM) for Europe or Japan, which remain on track.
Dr Ken Cunningham, Chief Executive Officer, said:"We now have greater
clarity from the FDA on its approach to our
filing and we are working to address these issues as soon as
possible. Flutiform(TM) remains on track in Europe and Japan,
and we remain confident that, once approved and launched in
its various markets, Flutiform(TM) will be a successful product
for SkyePharma in terms of both revenues and cash flows."
For further information please contact:
Ken Cunningham, Chief Executive Officer +44 207 491 1777
Peter Grant, Chief Financial Officer
+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.
Flutiform(TM) 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(TM) 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