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MEDA Dymista Filed in Europe


10/28/2011 9:05:40 AM

GÖTEBORG, Sweden--(BUSINESS WIRE)--Regulatory News:

“The regulatory filing for Dymista in Europe is important for our azelastine franchise. Earlier this year, Dymista was filed in the US and we will continue now with filings in other key markets” The marketing authorization application for Dymista (a novel formulation of azelastine hydrochloride and fluticasone propionate) has been filed in Europe. The application uses a decentralized procedure and the reference member state is Germany.

Dymista is a nasal spray formulation for patients with symptomatic treatment of moderate to severe allergic rhinitis and rhinoconjuctivitis. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long-term safety study with more than 600 patients.

"The regulatory filing for Dymista in Europe is important for our azelastine franchise. Earlier this year, Dymista was filed in the US and we will continue now with filings in other key markets", said Anders Lönner, CEO of Meda AB.

The marketing authorization application for Dymista (a novel formulation of azelastine hydrochloride and fluticasone propionate) has been filed in Europe. The application uses a decentralized procedure and the reference member state is Germany.

Dymista is a nasal spray formulation for patients with symptomatic treatment of moderate to severe allergic rhinitis and rhinoconjuctivitis. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long-term safety study with more than 600 patients.

"The regulatory filing for Dymista in Europe is important for our azelastine franchise. Earlier this year, Dymista was filed in the US and we will continue now with filings in other key markets", said Anders Lönner, CEO of Meda AB.

MEDA AB (publ)(STO:MEDAA) 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

Contacts

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


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