FDA’s first-cycle review of Reloxin® extended

Ipsen (Euronext: IPN) today announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Reloxin® (botulinum toxin of type A) Biologics License Application (BLA) in aesthetic indications (glabellar lines) has been extended to April 13, 2009.

The FDA did not issue any specific request on the occasion of this extension. Furthermore, FDA has confirmed in its Establishment Inspection Report that the manufacturing process for Ipsen’s botulinum toxin type A in its Wrexham (Wales) facility is in compliance with current Good Manufacturing Practices (CGMPs). 

In March 2006, Ipsen granted Medicis (NYSE: MRX) the rights to develop, distribute and commercialize Ipsen's botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians.

Ipsen announces its corporate agenda for 2009

Ipsen (Euronext: FR0010259150; IPN) announces today its corporate agenda* for 2009.

29 January 2009: Full year 2008 sales 
 2 March 2009: Full year 2008 results
 4 May 2009: First quarter 2009 sales
 4 June 2009: General shareholders’ meeting
 12 June 2009: Payment of 2008 dividend **
 28 August 2009: First half 2009 sales & results
 29 October 2009: First nine months 2009 sales

* This financial calendar is for indicative purposes only and the Group could change its publication dates should it deem it necessary. 
** Depending on the approval of the Board of directors (27 February 2009) and of the General shareholders’ meeting (4 June 2009)