Meda AB's Dymista Approved in Europe

Published: Jan 24, 2013

GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: MEDA AB (publ)(STO:MEDAA) Dymista has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial allergic rhinitis. National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches are anticipated in 2013 in several countries.

"Patients in Europe that suffer from allergic rhinitis will soon have access to a better treatment option than the current standard therapy. The faster and more complete effect offers significant benefit to the growing numbers of patients suffering from this difficult and inhibiting disease", said Anders Lönner, CEO of Meda AB.

About Dymista

Dymista is a novel nasal formulation of azelastine and fluticasone. The efficacy and safety of Dymista has been documented in several studies with more than 4,000 patients, including a long-term safety study with more than 600 patients. Dymista has consistently showed faster and more complete symptom relief than standard treatment. Dymista has been available in the US since September 2012.

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

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.

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Anders Larnholt

Vice President Corporate Development & IR

ph: +46 709-458 878

Paula Treutiger,

Investor Relations

ph: +46 733-666 599

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