BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

SkyePharma Inc. (SKYE) Says More Tests Needed for Asthma Drug


9/1/2009 7:23:52 AM

Bookmark and Share

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 addressed.

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:

SkyePharma PLC

Ken Cunningham, Chief Executive Officer +44 207 491 1777

Peter Grant, Chief Financial Officer

Financial Dynamics

Jonathan Birt +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.

About Flutiform(TM)

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

Contacts: RNS Customer Services 0044-207797-4400 Email Contact http://www.rns.com

Read at Reuters
Read at BioSpace.com

   
Asthma

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES