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European Commission (EC) Approves Meda AB (MEDA-A.ST)'s Zyclara


8/27/2012 8:18:46 AM

GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: Meda announced today that the European Commission (EC) has granted marketing authorization for Zyclara in the European Union. Zyclara (imiquimod 3.75% cream) is a patented product for the treatment of actinic keratosis. The approval is valid in all EU countries.

"Skin cancer is increasing and it is important to develop and improve the treatment of actinic keratosis. Zyclara is unique since it can treat large areas of the skin", said Anders Lönner, CEO of Meda AB.

About Zyclara and actinic keratosis

Actinic keratosis (AK), early skin carcinoma in situ is an under-diagnosed and under-treated disease and the number of affected patients is increasing. There is a close regional coexistence of invisible (subclinical AK lesions) as well as clinical visible AK lesions on areas of sun exposed skin - a phenomenon which is called field cancerization.

Zyclara is to date the first clinically proven treatment option which can detect and eliminate subclinical as well as clinical AK lesions on large areas of the skin. Zyclara has shown in a large clinical development program to be an effective therapy in eliminating both kinds of AK lesions and with low recurrence rate.

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.

Forward-looking statements

This press release is not an offer to sell or a solicitation to buy shares in Meda. This press release also contains certain forward-looking statements with respect to certain future events and Meda’s potential financial performance. These forward-looking statements can be identified by the fact that they do not relate only to historical or current facts, and may sometimes include words such as “may”, “will”, “seek”, “anticipate”, “expect”, “estimate”, “intend”, “plan”, “forecast”, “believe” or other words of similar meaning. These forward looking statements reflect the current expectations on future events of the management at the time such statements are made, but are made subject to a number of risks and uncertainties. In the event such risks or uncertainties materialize, Meda’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research and product development, manufacturing and commercialization, the impact of competitive products, patents, legal challenges, government regulation and approval, Meda’s ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Meda AB’s interim or annual reports, prospectuses or press releases. Listeners and readers are cautioned that no forward-looking statement is a guarantee of future performance and that actual result could differ materially from those contained in the forward-looking statements. Meda does not intend, nor undertakes, to update any such forward looking statements.

This information was brought to you by Cision http://www.cisionwire.com

Contact:

MEDA AB (publ)

Anders Larnholt, Vice President Corporate Development & IR

+46 709-458 878



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