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 PLC (SKYEF) Announces Exclusive Development, License and Marketing Agreement for Flutiform(TM) with Sanofi (France) (SASY.PA) in Mexico, Central and South America


7/28/2011 10:02:44 AM

LONDON, UK, 28 July, 2011 – SkyePharma PLC (LSE: SKP) today announces that the Group (”SkyePharma”) has entered into an exclusive Development, License and Marketing Agreement with Sanofi in Mexico, Central and South America for Flutiform™, its lead development product for the treatment of asthma.

Under the agreement, SkyePharma is eligible for initial, approval and sales milestones potentially worth several million US dollars and a high single digit percentage royalty on net sales.

Under the agreement, Sanofi aims to pursue marketing authorisation applications for Flutiform™ throughout the region, including in Mexico, Brazil, Argentina, Venezuela and Colombia. The applications will be based on data included in, and subject to approval of, the European Marketing Authorisation Application (“MAA”) for Flutiform™ filed by Mundipharma International Limited. Preparations continue to be made for the potential launch of Flutiform™ in Europe in H2 2011.

Sanofi currently manufactures Flutiform™ under contract to SkyePharma at its factory in Holmes Chapel, UK, and this arrangement has been extended to allow Sanofi to manufacture Flutiform™ and supply it directly to its group companies for Mexico, Central and South America using certain ingredients and components supplied by SkyePharma.

Sanofi is the leading pharmaceutical company in Latin America, and will reinforce its position within the asthma market, with Flutiform™, once approved.

SkyePharma's Chief Executive Officer, Axel Müller, said: “We are very pleased to have attracted such an experienced partner as the licensee for Flutiform™ in Mexico, Central and South America, and we look forward to working with Sanofi as both manufacturer and licensee for Flutiform™. We are continuing to make preparations with our partner Mundipharma, for the potential launch of Flutiform™ in Europe later this year.”

For further information please contact:

SkyePharma PLC

Axel Müller, Chief Executive Officer

+44 207 881 0524

Peter Grant, Chief Financial Officer

Singer Capital Markets Limited

Shaun Dobson / Claes Spång

+44 203 205 7500

Financial Dynamics

Jonathan Birt /Sue Quigley

+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™

Flutiform™ is a fixed dose combination of fluticasone, an inhaled corticosteroid (“ICS”), and formoterol, a long-acting beta agonist (“LABA”) in a Metered Dose Inhaler (“MDI”). Flutiform™ is licensed to Mundipharma International Ltd in Europe and most other territories outside Japan and the Americas and is licensed to Kyorin Pharmaceutical Company Ltd in Japan. A marketing authorisation application for Flutiform™ was filed in Europe in March 2010 and is progressing in line with the Board’s expectations, and preparations continue for its potential launch in the second half of 2011. The development of Flutiform™ in Japan is making good progress with two Phase III studies underway, and the aim of filing the Japanese NDA by the end of March 2013.

Mo Noonan

Senior Manager

Financial Dynamics

Holborn Gate, 26 Southampton Buildings

London, WC2A 1PB

D +44 (0)20 7269 7116

M +44 (0)7876 444 977

www.fd.com



Read at BioSpace.com

   

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