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MEDA's Dymista Approved by the FDA



5/2/2012 6:57:59 AM

GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, Dymista has consistently showed a rapid and more complete symptom relief than standard treatment.

"Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work and live a normal life. Dymista can offer an effective treatment for patients suffering from these symptoms”, said Anders Lönner, CEO of Meda AB. “The approval of Dymista represents an important achievement for Meda’s clinical development groups in the US and Europe. Meda’s franchise in the allergy area is strengthened and gives opportunities for the company to grow and establish collaborations in the field. Dymista will be available in the US during the second half of 2012”.

“Many patients are dissatisfied with currently available treatments”, said Dr. Warner W. Carr, MD, FAAAAI, FACAAI, Allergy & Asthma Associates of Southern California, Mission Viejo, CA, USA, principal investigator in the clinical development program for Dymista. “At the first onset of seasonal allergies, Dymista has the potential to help reduce the number of allergy medications patients may need to take and offers greater efficacy than traditional first line agents - which in turn can lead to greater compliance and more efficient use of healthcare system resources for this common condition”.

The United States Patent and Trademark Office (USPTO) has also issued two patents related to Dymista. The patents extend through 2023 and 2026, excluding potential patent term extension.

About Dymista

Dymista Nasal Spray is approved in the U.S. for the relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone proprionate for symptomatic relief. SAR annually affects approximately 60 million people in the U.S. Dymista is administered twice daily in each nostril. 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.

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

Contact:

Anders Larnholt, Vice President Corporate Development & IR

ph: 46 709-458 878


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