Zyclara receives positive opinion from the Committee for Human Medicinal Products in the European Union

The Committee for Human Medicinal Products (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion regarding marketing authorization of
Zyclara (treatment of actinic keratoses on large skin areas). The European
Commission generally follows the recommendations of the CHMP (EMA) and announces
its final decision within three months after the recommendation. Following an
approval, the marketing authorization is valid across the European Union.

"I’m pleased that the CHMP has adopted a positive opinion for Zyclara, which
will further strengthen Meda’s product portfolio in dermatology. Our launch
pipeline looks very promising", said Anders Lönner, CEO of Meda AB.

About actinic keratosis and Zyclara
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 - an imiquimod 3.75% cream - 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.

“Zyclara represents a breakthrough product in actinic keratosis management and
could transform how this disease is managed”, said Prof. Eggert Stockftleth,
Professor of dermatology, Charité, Berlin and founder of the EpiDerm project
which is sponsored by the European Union and has the aim to raise awareness of
AK.
For further inquiries, please contact:
Anders Larnholt, Vice President Corporate Development & IR ph: +46 709-458 878
anders.larnholt@meda.se

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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