Positive study supporting a potential once-daily nasal antihistamine

Positive study supporting a potential once-daily nasal antihistamine

In October 2008, the US Food and Drug Administration (FDA) accepted the New Drug
Application (NDA) for the newly formulated higher strength azelastine nasal
spray as complete for substantive review after initial evaluation. 

This NDA contained data on six phase III studies and a long-term safety study,
involving more than 1,600 patients in total. In these clinical studies, the
product demonstrated improvement in nasal symptom relief scores in patients with
seasonal and perennial allergic rhinitis, and was well tolerated.

Parallel to FDA's review process, Meda initiated a seventh phase III study. This
study has now been completed and the results support a potential claim for a
once-daily administration. Meda has decided to add this study to the submitted
NDA. In response, FDA has requested three additional months to review this new
information. Therefore, Meda anticipates a formal response on this NDA during
September 2009.

For more information contact:

Anders Larnholt, VP Corporate Development & Investor Relations	tel. +46 709 458
878

MEDA AB (publ) is a leading international specialty pharma company. The company
specialises in marketing and pharmaceutical development in late clinical stage.
Acquisitions and long-term partnerships drive the company's strategy. Meda is
represented by its own organizations in about 40 countries. Meda's products are
sold in 120 countries worldwide. The Meda share is listed under Large Cap on the
Nasdaq OMX Nordic Stock Exchange Stockholm. Find out more, visit www.meda.se.