SkyePharma regains United States marketing rights to Flutiform
LONDON, UK, 20 August 2010 - SkyePharma PLC (LSE: SKP) announces that it has regained the United States marketing rights to FlutiformTM, an investigational treatment for persistent asthma in patients 12 years of age and older.
Abbott Respiratory LLC ("Abbott") has terminated the U.S. Development, License and Marketing Agreement for FlutiformTM with SkyePharma. Under the agreement there are no material payments due by either party on termination.
As previously announced, following a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter received in January 2010 in respect of the New Drug Application (NDA) for FlutiformTM, SkyePharma is continuing to investigate whether there is a viable way forward for FlutiformTM in the United States. In that event, the Group would seek a new U.S. licensee with strategic interest in the product and which would finance any additional clinical work required. The NDA was transferred back to SkyePharma earlier this year.
The European Marketing Authorisation Application for FlutiformTM, filed in March 2010, remains under regulatory review in Europe, where the regulatory approach is different from the United States, and progress continues to be made with the development in Japan, with Phase III studies expected to commence by March 2011.
Dr Ken Cunningham, Chief Executive Officer, said:
"Given the delay in obtaining approval for FlutiformTM in the United States, we are not surprised that Abbott has decided to terminate its interest in the product. However, SkyePharma is continuing to investigate whether there is a viable way forward in the United States, and we have not given up on finding a pathway. If there is a way forward, the Group would seek a new U.S. licensee with strategic interest in the product and which would finance any additional clinical work required.
"In the meantime, FlutiformTM is under review in Europe, which remains a very big market for inhaled combination products for asthma.
For further information please contact:
SkyePharma PLC
Ken Cunningham, Chief Executive Officer
+44 207 491 1777 begin_of_the_skype_highlighting +44 207 491 1777 end_of_the_skype_highlighting
Peter Grant, Chief Financial Officer
Financial Dynamics
Jonathan Birt /Sue Quigley
+44 207 831 3113 begin_of_the_skype_highlighting +44 207 831 3113 end_of_the_skype_highlighting
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.