FDA accepts NDA filing for Retigabine

FDA accepts NDA filing for Retigabine

The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug
Application (NDA) seeking marketing approval for Retigabine. In addition, the
European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA
(Marketing Authorization Application) was successfully validated thus enabling
the MAA review to commence. 
 
Retigabine comprises a new way of affecting potassium channels in the central
nervous system. It has been documented to treat epilepsy and has a different
mechanism of action compared to current antiepileptic therapies. 

Meda's partner for Retigabine, Valeant Pharmaceuticals International (Valeant),
has a global collaboration agreement with the pharmaceutical company
GlaxoSmithKline for the commercialization of Retigabine. Meda is entitled to
receive significant royalties on sales and certain milestone payments from
Valeant on Retigabine. This acceptance by the FDA triggers a milestone payment
to Meda of 8 MUSD.

If questions, please contact:

Anders Larnholt, Vice President Corporate Development & IR	ph: +46 709-458 878


MEDA AB (publ) is a leading international specialty pharma company. Meda's
products are sold in 120 countries worldwide and the company is represented by
its own organizations in more than 40 countries. The Meda share is listed under
Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more,
visit www.meda.se.