GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News:
Valeant Pharmaceuticals International Inc. (Meda’s partner for ezogabine - known as retigabine outside of the U.S.) has received approval from the U.S. Food and Drug Administration (FDA) for Potiga (ezogabine). Potiga is approved for adjunctive treatment for adults with partial-onset seizures. It is the first approved potassium channel opener for this indication.
“We are glad to see Potiga approved in the U.S. and we hope that this novel treatment can be beneficial to patients”, said Anders Lönner, CEO Meda AB.
This FDA approval triggers a milestone payment to Meda of 6 MUSD. Meda is also entitled to receive royalties in the U.S. of 7% on net sales and other milestone payments related to future development of the product. GlaxoSmithKline is responsible for the global commercialization.
Trobalt (retigabine) was approved in Europe on 28 March 2011 and the launch by GlaxoSmithKline has already begun in Germany, the UK, Switzerland and Denmark. Meda will receive a royalty of between 6 - 8% in Europe.
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 50 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.
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Anders Larnholt, 46 709-458 878
Vice President Corporate Development & IR ph:
KEYWORDS: Europe Sweden
INDUSTRY KEYWORDS: Health Pharmaceutical FDA